Safety Clinical
Resume:
WILLIAM GERSON, DO. CPI
WILLIAM GERSON, DO, CPI
*******@*********.***
Over 5 years as a practicing Neurologist with the last 9+ years working as a Certified Principal
Investigator on industry sponsored trials with over 180 studies in early and late phase research
involving a variety of medical indications including special populations, Neuroscience (migraine,
sleep disorder, epilepsy, movement disorders, pain, schizophrenia, depression, bipolar disorder,
and eating disorders, and others), DM, Hypogonadism, Hypertension, tyramine challenge,
Biologics, glucose clamp, Depression, Epilepsy, Arthritis, dyslipidemia, and others.
Successful skills for being part of the Pharma team include leadership, preparedness, team work,
communication and respect for my co-workers.
I. PROFESSIONAL EXPERIENCE:
03/12 – Present Principal Investigator
Piedmont Clinical Research /Segal Institute of Clinical Trials
Miami, FL
04/07 – 03/12 Principal Investigator/ Sub-Investigator
CNS Comprehensive Clinical Development, Inc., Miramar, FL
07/06 – 03/07 Medical Director/ Investigator
In Vivo Clinical Trials, Miami, FL
07/04 – 07/06 Principal Investigator
PDGI/ Clinical Pharmacology Associates, Miami, FL
02/04 – 07/04 Sub-Investigator
Comprehensive Phase One, Ft. Lauderdale, FL
04/00 – 07/04 Attending Physician
Neuro-Rehabilitation and General Neurology Group Practice,
Miami, FL
04/99 – 08/00 Attending Physician
Hospital and Office Based Neurology Practice, Miami, FL
II. EDUCATION & CREDENTIALS:
D.O. Doctor of Osteopathic Medicine 1991
Southeastern University of Health Sciences, North Miami Beach, FL
B.S. Bachelor of Science in Microbiology and Cell Sciences 1987
University of Florida, Gainesville, FL
III. MEDICAL LICENSURE & CERTIFICATION:
LICENSURE:
D.O. OS6990 Exp. March 31, 2014
DEA BG3438694 Exp. September 30, 2013
CERTIFICATION:
NIH Training in Good Practice, Certified
NIH Clinical Pharmacology courese, 2011 - 2012
WILLIAM GERSON, DO. CPI
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IV. POST DOCTORAL TRAINING/RESIDENCY/FELLOWSHIP/INTERNSHIP:
1996 – 1997 Cleveland Clinic Foundation
Cleveland, Ohio
Postgraduate Education
EEG/EMG/EP Intra-operative and Clinical
Monitoring & Sleep Fellowship, Dr. Hans Lüders
Sleep Medicine Dr. D. Dinner
1992 – 1995 Cleveland Clinic Foundation
Cleveland, Ohio
Neurology Residency and
EMG/NCS 6 mos. Fellowship
3 mos. EEG course
1992 – 1992 Cleveland Clinic Foundation
Cleveland, Ohio
Postgraduate Education
Internal Medicine
1991 – 1992 Cleveland Clinic Foundation
Cleveland, Ohio
Postgraduate Education
Transitional Year Residency
1987 – 1991 Southeastern University of Health Sciences
North Miami Beach, Florida
Cum laude
Osteopathic Medicine, D.O.
1983 – 1987 University of Florida
Gainesville, Florida
Bachelor of Science, Microbiology and Cell Science
V. RATER CERTIFICATION/SCALES:
Clinical Global Impression (CGI-S/I)
Antidepressant Treatment Response Questionnaire (ATRQ)
Beck Depression Inventory
Brief Psychiatric Rating Scale (BPRS)
Calgary Depression Scale for Schizophrenia (CDSS)
Clinical Global Impression (CGI)
Clinical Opiate Withdrawal Scale (COWS)
Clinicians Interview Based Impression of Change (CIBIC)
Cogstate Cognitive Assessment
Columbia-Suicide Severity Rating Scale (C-SSRS)
Conners’ Rating Scales
Global Assessment of Functioning (GAF)
Hamilton Anxiety (HAM-A)
Hamilton Depression (HAM-D)
Inventory of Depressive Symptomotology (IDS-30)
WILLIAM GERSON, DO. CPI
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Kiddie Schedule of Affective Disorders (K-SADS)
MATRICS Consensus Cognitive Battery (MCCB)
Mini International Neuropsychiatric Interview (MINI)
Mini-Mental State Examination (MMSE)
Modified Himmelsbach Opiate Withdrawal Scale (MHOWS)
Montgomery-Asburg Depression Rating Scale (MADRS)
Negative Symptom Assessment (NSA-16)
Personal and Social Performance (PSP)
Positive and Negative Syndrome Scale (PANSS)
Sheehan Disability Scale (SDS)
Stroop Color Word Test
Structured Clinical Interview for DSM-IV (SCID)
Subscale for the Assessment of Negative Symptoms ( SANS)
Young Mania Rating Scale (YMRS)
VI. OTHER TRAINING:
Osteopathic and American Boards of Psychiatry and Neurology, eligible
National Board of Osteopathic Medical Examiners
Advanced Cardiac Life Support
DEA full prescribing privileges
Certified Physician Investigator (CPI), APPI
NIH Training in Good Practice, certified
NIH Clinical Pharmacology Course
VII. PROFESSIONAL MEMBERSHIPS & FACILITY AFFILIATIONS:
MEMBERSHIPS
American Academy of Pharmaceutical Physicians
Drug Information Association
American Academy of Neurology
American Osteopathic Association
Florida Osteopathic Medical Association
AFFILIATIONS
03/12 – Present Affiliation with Following SICR – Managed Entities:
Healthcare Clinical Data, Inc, Scientific Clinical Research, Inc and
Innovative Clinical Research, Inc
Piedmont Clinical Research, Inc
1065 NE 125th Street Suite 417/221/219
03/12 – Present
WILLIAM GERSON, DO. CPI
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North Miami, FL33161
VIII. PUBLICATIONS AND PRESENTATIONS:
PRESENTATIONS, ARTICALES. PAPERS
2011 Lack of Tyramine Pressor Response Effect with Oral CX157 (Tririma), a Reversible MAOI.
Daniel Burch, M.D.; Mahnaz Asgharnejad, Pharm.D.; William Gerson, D.O.; CPI
2007 Pharmacokinetics and Relative Bioavailability of Diazepam Following Intramuscular
Administration with Vanquix in Healthy Volunteers, Fall 2006
IX. CLINICAL RESEARCH EXPERIENCE:
Sub Investigator for Clinical Research Studies
Migraine
01/13 -- Present A Parallel Group, Double-Blind, Randomized, Placebo Controlled Phase 1b
Trial to Evaluate the Safety Pharmacokinetics, and Efficacy of a Single
Dose of (study drug) Administered Intravenously in Patients with Frequent
Episodic Migraines
ADHD
05/12 – Present A Phase IV, Randomized, Double-Blind, Multicenter, Parallel-Group,
Active-Controlled, Dose-Optimization, Safety and Efficacy Study of (Study
Drug) compared with (Study Drug) with a Placebo Reference Arm, in
Adolescents aged 13-17 years with ADHD
05/12 – Present A Phase IV, Randomized, Double-Blind, Multicenter, Parallel-Group,
Active-Controlled, Forced-Dose Titration, Safety and Efficacy Study of
(Study Drug) compared with (Study Drug) with a Placebo Reference Arm,
in Adolescents aged 13-17 years with ADHD
03/12 – Present A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to
Evaluate the Efficacy and Safety of (Study Drug) Extended Release Tablets
WILLIAM GERSON, DO. CPI
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as Adjunctive Therapy in Children with Impulsive Aggression Comorbid
with Attention-Deficit/ Hyperactivity Disorder (ADHD)
03/12 – 04/12 A 40-Week, Phase IV, Double-Blind, Placebo-Controlled, Multicenter,
Randomized-Withdrawal Study to Evaluate the Long-Term Efficacy and
Safety of (Study Drug) Extended-Release in Children and Adolescents with
Attention Deficit Hyperactivity Disorder
Bipolar Disorder
07/12 – Present A Phase III, Multicenter, Double-Blind, Fixed-Dose, Parallel-Group, Three
Week Placebo-Controlled Trial Evaluating the Safety and Efficacy of (Study
Drug) in Subjects with Bipolar I Disorder Experiencing an Acute Manic or
Mixed Episode
Depression
10/12 – Present Phase III, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo
Controlled, Flexible-Dose Titration, Efficacy and Safety Study of (Study
Drug) in Combination with an Antidepressant in the Treatment of Adults
with Major Depressive Disorder with Inadequate Response to Prospective
Treatment with an Antidepressant
08/12 – Present A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel
Group Study to Investigate the Efficacy and Safety of (Study Drug) versus
Placebo, as Adjunctive Therapy in Patients with Major Depressive Disorder
having Inadequate Response to Ongoing Antidepressant Treatment
04/12 – Present (Study Drug/Study Drug) versus (Study Drug) and versus (Study Drug) in
Moderate to Severe Major Depressive Disorder (MDD): A Randomized,
Double-Blind Phase III Clinical Trial of 10 Weeks
03/12 – Present A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group,
Assessment of the Efficacy, Safety and Tolerability of (Study Drug)
Modified Release Tablet, 125 mg Twice Per Day in Subjects with Treatment
Resistant Depression
03/12 – Present A Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of
(Study Drug) vs. Placebo in the Treatment of Psychotic Symptoms in
Patients with Major Depressive Disorder with Psychotic Features
03/12 – Present A Phase 3, Long-Term, Open-Label, Flexible-Dose, Extension Study
Evaluating the Safety and Tolerability of (Study Drug) (15 and
20 mg) in Subjects with Major Depressive Disorder
03/12 – Present A Randomized, Double-Blind, Parallel-Group, Active-Controlled, Flexible
Dose Study Evaluating the Effect of (Study Drug) vs (Study Drug) on Sexual
WILLIAM GERSON, DO. CPI
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Functioning in Adults with Well Treated Major Depressive Disorder
Experiencing SSRI-Induced Sexual Dysfunction
03/12 – Present Phase IIb/III Multicenter, Randomized, Double-Masked, Placebo-Controlled,
Parallel Study to Investigate the Safety and Efficacy of 20 mg (Study Drug)
versus Placebo in Adult Subjects with Major Depressive Disorder Followed
by a 52-Week Open-Label Extension
General Medicine
03/12 – 06/12 An Open Label Safety Study of (Study Drug) in Subjects with
Osteoarthritis or Chronic Low Back Pain
03/12 – 05/12 A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of
(Study Drug) for the Treatment of Opioid-Induced Constipation (OIC) in
Subjects with Non-Malignant Chronic Pain Receiving Opioid Therapy
Schizophrenia
10/12 – Present A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Assess
the Efficacy and Safety of (Study Drug) for the Treatment of Tradive
Dyskinesia in Subjects with Schizophrenia or Schizoaffective Disorder
10/12 – Present A Randomized, Double-Blind, Placebo-Controlled, Parallel, 12-Week, Phase
III Study of 2 Doses of an (Study Drug) or Placebo as an Adjunctive Pro-
Cognitive Treatment in Schizophrenia Subjects on Chronic Stable Atypical
Antipsychotic Therapy
10/12 – Present A Multicenter 40-Week Extension Study to Evaluate the Safety and Clinical
Effects of Prolonged Exposure to 1 and 2 mg Doses of (Study Drug) as an
Adjunctive Pro-Cognitive Treatment in Subjects with Schizophrenia on
Chronic Stable Atypical Antipsychotic Therapy
08/12 – Present A Long-Term, Phase III, Multicenter, Open-Label Trial to Evaluate the Safety
and Tolerability of Oral (Study Drug) as Maintenance Treatment in Adults
with Schizophrenia (DeNovo)
06/12 – 08/12 A Placebo-and Positive-Controlled Study of the Electrophysiological
Effects on the QT Interval after a Supratherapeutic Dose of (Study Drug) in
Subjects with Schizophrenia
04/12 – Present A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to
Evaluate the Effect of Add-On (Study Drug) on Schizophrenia Negative
Symptoms
02/12 – 09/12 A Phase III, Short-Term, Multicenter, Placebo-Controlled, Randomized,
Withdrawal Study of (Study Drug) Monohydrate in Patients with DSM-IV-TR
WILLIAM GERSON, DO. CPI
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Schizophrenia
03/12 – Present A Phase III, Multicenter, Randomized, 24-Week, Double-Blind, Parallel-
Group, Placebo-Controlled study to Evaluate Efficacy and Safety of (Study
Drug)in stable patients with Persistent, Predominant Negative Symptoms of
Schizophrenia Treated with Antipsychotics Followed By a 28-Week Double-
Blind Treatment Period
03/12 – Present A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled
Study of Three Fixed Doses of (Study Drug) in the Treatment of Adults with
Acute Schizophrenia
03/12 – Present A Multicenter, Double-Blind, Placebo-Controlled, Comparator Study of 2
Doses of (Study Drug) versus Placebo in Patients with DSM-IV-TR
Schizophrenia
03/12 – Present A Long-Term, Phase III, Multicenter, Open-Label Trial to Evaluate the Safety
and Tolerability of Oral (Study Drug) as Maintenance Treatment in Adults
with Schizophrenia
03/12 – 09/12 A Long-Term, Open-Label, Phase III, Multicenter Study of (Study Drug)
Compared to Atypical Antipsychotic Standard of Care in Patients with DSM-
IV-TR Schizophrenia
03/12 – 09/12 A Long Term Open Label Safety study of (Study Drug) in patients with DSM
IV-TR Schizophrenia
03/12 – Present A Phase II/III, Multi-Center, Randomized, 4-Week, Double-Blind, Parallel
Group, Placebo and Active-Controlled Trial of the Safety and Efficacy of
(Study Drug) versus Placebo in Patients with an Acute Exacerbation of
Schizophrenia
03/12 – Present A Phase III, Multicenter, Randomized, 3-Month, Double-Blind, Parallel-
Group, Placebo-Controlled Study to Evaluate Efficacy and Safety of (Study
Drug) in Stable Patients with Sub-Optimally Controlled Symptoms of
Schizophrenia Treated Antipsychotics, Followed by a 9-Month, Double-
Blind Treatment Period
03/12 – Present A Phase III, Short-Term, Multicenter, Placebo-Controlled, Randomized
Withdrawal Study of (Study Drug) in Patients with DSM-IV-TR
Schizophrenia
Substance Abuse
WILLIAM GERSON, DO. CPI
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08/12 – Present An Open-Label Study to Assess the Safety and Tolerability of (Study Drug)
in Opioid Dependent Subjects
03/12 – Present A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of
(Study Drug) for the Treatment of Opioid-Induced Constipation (OIC) in
Subjects with Non-Malignant Chronic Pain Receiving Opioid Therapy
Previous Clinical Research Studies
2011
A Study to Assess Potential Pharmacokinetic Interaction between (Study
Drug) and (Study Drug) after Multiple-Dose Administration
A Study to Evaluate the Effect of (Study Drug) on the Pharmacokinetics of
(Study Drug) in Healthy Volunteers
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single
Doses of (Study Drug) Dosed in Combination with (Study Drug) in Healthy
Elderly Male, Elderly Female and Young Female Subjects
A Double Blind, Active-Comparator-, and Vehicle-Controlled, Multiple-Dose
Study to Evaluate the Efficacy and Safety of (Study Drug) in Patients with
A Single Dose Study to Evaluate the Effects of Controlled, on the
Pharmacokinetics of (Study Drug) in Subjects
A Study to Evaluate the Comparative (Study Drug) of Four Formulations of
(Study Drug) in Healthy Subjects
A Study to Evaluate the Effect of Food on the Pharmacokinetics of (Study
Drug)
A Phase 1, Randomized, Single Center, Open-Label, Multiple-Dose, Three-
Way Crossover Study to Evaluate the Efficacy, Tolerability and Safety of
(Study Drug) in Comparison with (Study Drug) delayed release(Study Drug)
and (Study Drug) in Healthy Volunteers.
A Randomized, Double Blind, (Study Drug) Ascending Dose Study to
Evaluate the Safety, Tolerability, and Pharmacokinetics of (Study Drug) in
Elderly Subjects with and without Alzheimer’s Disease
A Phase 1, Double-blind, Randomized, Placebo-controlled,
Multiple Ascending Dose Study to Examine the Safety,
Tolerability, and Pharmacokinetics of (Study Drug)
in Healthy Subjects
WILLIAM GERSON, DO. CPI
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A Double-Blind, Randomized, Placebo- and Active Comparator-
Controlled, 4-Week Study to Evaluate the Safety, Tolerability,
Pharmacokinetics and Pharmacodynamics of Multiple Oral
Doses of (Study Drug) in Subjects with
Type 2 Diabetes Mellitus
A Randomized, Double-blind, Placebo-Controlled, Ascending
Single-Dose Study of the Safety and Tolerability of
Subcutaneous (Study Drug) in Healthy Volunteers
Placebo-Controlled, Randomized, Single and Multiple Dose
Study to Evaluate the Safety, Tolerability, and
Pharmacokinetics of in Healthy Subjects
A Phase I, Multiple-Dose, Randomized, Double-Blind, Two-
Period, Safety, Tolerance and Pharmacokinetic Study
Comparing (Study Drug) Modified Release Tablets to (Study
Drug) in Healthy Volunteers
Safety and Tolerability of (Study Drug) Ascending Doses of
(Study Drug) in Patients with Type 2 Diabetes Mellitus
A Single-Dose Study to Assess the Pharmacokinetics, Safety, and
Tolerability of (Study Drug) in Adolescents
A Study to Assess the Effect of Co-administration of (Study Drug)
and (Study Drug) on the Pharmacokinetics of
A Study to Assess Definitive Bioequivalence Between (Study Drug)
Tablets and Co-Administration of (Study Drug) and (Study Drug)
A Multiple Dose Study to Evaluate the Safety, Tolerability,
Pharmacokinetics and Pharmacodynamics of (Study Drug) in Obese
Subjects and in Patients with Type 2 Diabetes
A Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics,
and Pharmacodynamics of (Study Drug) in Healthy Elderly, Obese Male and
Female Subjects, and in Healthy Young Female Subjects
A 4 Period, Open Label, Randomized, Crossover Study to Investigate the
Safety, Effects of Food and evening dosing on the Pharmacokinetics of
Single Oral Doses of (Study Drug) in Healthy Male and Female Subjects
A Phase 1, Single-Center, Double-Blind, Randomized, Single- and Multiple-
Ascending Dose Study of (Study Drug) in Healthy Young and Older
Volunteers
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A Phase 1, Double-blind, Randomized, Placebo-controlled, Single
Ascending Dose Study to Examine the Safety, Tolerability, and
Pharmacokinetics of (Study Drug) in Healthy Volunteers
A Phase 2, Randomized, Two-Stage, Open-Label, Multi-Center, 24-Week
Study to Evaluate the Efficacy, Safety, and Tolerability of (Study Drug) in
Subjects with Type 2 Diabetes Mellitus
An Open-Label, Randomized, Two-Period, Crossover Pivotal Study to
Evaluate the Relative Bioequivalence of an Extended-Release Test Tablet
Formulation of (Study Drug) Compared to an Equivalent Dose of the (Study
Drug) in Normal Healthy Subjects Under Fasting Conditions
An Open-Label, Randomized, Two-Period, Crossover Pivotal Study to
Evaluate the Relative Bioequivalence of an Extended-Release Test Tablet
Formulation of (Study Drug) Compared to an Equivalent Dose of the (Study
Drug) in Normal Healthy Subjects Under Fed Conditions
A Randomized, Double-blind, Placebo-controlled, Ascending Multiple Dose
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and
Pharmacodynamics of (Study Drug) in Healthy Men and Postmenopausal
Women with Low Bone Mineral Density
A Double-Blind, Placebo-Controlled, Randomized, Parallel-Group, Multi-
Center Study to Evaluate the Multiple Dose Pharmacokinetic and
Pharmacodynamic Characteristics of (Study Drug) in Subjects With Type 2
Diabetes Mellitus
Post-Market Surveillance of Tobacco Products: A Multicenter Clinical Trial
of Natural Adopters of Cigarettes, Moist Snuff, Camel SNUS, and Dual Use
2010
A Randomized, Multicenter, Double-Blind, Double-Dummy, Active-
controlled, Parallel-design, Phase II Study to Assess the Efficacy, Safety,
and Pharmacokinetics of 75 and 100 mg Once-a-month Delayed-release
(Study Drug) Formulations Compared to a 150 mg Once-a-Month
Immediate-release (Study Drug) Formulation for 3 Months in
Postmenopausal Women Age 45-80
A Single and Multiple-Dose Study to Evaluate the Safety, Tolerability,
Pharmacokinetics, and Pharmacodynamics of (Study Drug)
A Multi-centered, Randomized, Double-Blind, Placebo-Controlled, Single
Dose Efficacy and Safety Study of (Study Drug) for Inhalation in
Schizophrenic Patients with Agitation
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A Single-Dose Study to Assess the Pharmacokinetics, Safety, and
Tolerability of (Study Drug) in Adolescents
A Placebo-Controlled Multiple Dose Study to Evaluate the
Pharmacokinetics and Pharmacodynamics of (Study Drug) in Subjects with
Type 2 Diabetes
A Study to Evaluate the Comparative Bioavailability of Three Formulations
of (Study Drug) in Healthy Subjects
A Two-Period, Two-Treatment, Open Label, Two-Way Steady-State
Crossover Bioequivalence Study of (Study Drug) Extended Release 400 mg
Tablets under Fasting Conditions in Schizophrenic Patients
A Single-Dose Study to Evaluate the Safety, Tolerability, bioavailability and
IV Pharmacokinetics of (Study Drug) in Healthy Subjects
A Study of Higher Single Doses of (Study Drug) in Type 2 Diabetics
A Study to Evaluate the Effect of Multiple-Doses of (Study Drug) on the
Pharmacokinetics of Oral Contraceptives in Healthy Female Subjects
A Multiple Dose Study of (Study Drug) in Elderly Subjects
A Study to Assess the Effect of Co-administration of (Study Drug) and
(Study Drug) on the Pharmacokinetics of (Study Drug)
A 4 Period, Open Label, Randomized, Crossover Study to Investigate the
Safety, XXXXXX and evening dosing on the Pharmacokinetics of Single
Oral Doses of XXXXX in Healthy Male and Female Subjects
A Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics,
and Pharmacodynamics of (Study Drug) in Healthy Elderly Male and
Female Subjects, and in Healthy Young Female Subjects
A Randomized Clinical Trial to Evaluate the Effects of (Study Drug) on
(Study Drug)in Healthy Women
A Phase 2, Randomized, Two-Stage, Open-Label, Multi-Center, 24-Week
Study to Evaluate the Efficacy, Safety, and Tolerability of (Study Drug) in
Subjects With
A Two-Period, Two Treatment, Two-Way Steady-State Crossover
Bioequivalence Study of(Study Drug) 300 mg Tablets under Fasting
Conditions in Schizophrenic Patients
A Double-Blind Randomized, Parallel Trial to Define the Effects of (Study
Drug) Using a Clinical and a (Study Drug) Dose Compared to Placebo and
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(Study Drug) (a Positive Control) in Healthy Men and Women: A Thorough
ECG Trial
A Double-Blind, Randomized, Placebo-Controlled, Sequential Cohort Study
To Evaluate the Safety, Tolerability, Pharmacokinetics, and
Pharmacodynamics of Multiple Oral Daily Doses of (Study Drug) in
Subjects with Type 2 Diabetes Mellitus.
A Randomized, Double-blind, Placebo-controlled, Ascending Dose Study to
Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics
of (Study Drug) following a Single Intravenous or a Single Subcutaneous
Administration in Healthy Subjects and in Subjects with Moderate to Severe
Psoriasis
A Phase 1, Single-Center, Randomized, Double-Blind, Placebo-Controlled,
Multiple-Ascending Dose Study of (Study Drug) in Healthy Older Volunteers
An Open-Label Study To Assess The Pharmacokinetics, Safety, And
Pharmacodynamics Of Repeated Doses Of (Study Drug) In Adult Patients
With Type 1 Gaucher Disease.
A Randomized, Open-Label, Phase 2 Study of (Study Drug) in Healthy
Subjects
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of (Study
Drug) with 28 days of Subcutaneous Injections in Subjects with Type 2
Diabetes Mellitus
A Multi-Center, Randomized, Double-Blind, Multiple Ascending Dose,
Placebo-Controlled, Parallel Group, 3-Part Study to Investigate the Safety,
Tolerability, Pharmacokinetics, and Pharmacodynamics of (Study Drug)
Administered Once weekly for 4 Weeks in Patients with Type 2 Diabetes
Mellitus on a stable dose of (Study Drug)
2009
An Open-Label Clinical Trial of the Safety and Pharmacokinetics of Single
Escalating Doses of (Study Drug) in Healthy Volunteers
A Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Parallel,
Dose-Escalation Study of (Study Drug), a Humanized Antibody to (Study
Drug), in Patients with Rheumatoid Arthritis
Clinical phase I/IIA study of subcutaneous administration of (Study Drug) in
Rheumatoid Arthritis patients on stable dose (Study Drug)
A Two-Period, Two Treatment, Two-Way Steady-State Crossover
Bioequivalence Study of (Study Drug) 300 mg Tablets under Fasting
Conditions in Schizophrenic Patients
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A Two-Period, Two-Treatment, Open Label, Two-Way Steady-State
Crossover Bioequivalence Study of (Study Drug) Extended Release 400 mg
Tablets under Fasting Conditions in Schizophrenic Patients
A Single-Center, Double-Blind, Randomized, Placebo-Controlled,
Sequential Cohort Study To Evaluate The Safety,Tolerability,
Pharmacokinetics And Pharmacodynamics Of Multiple Ascending Oral
Doses Of (Study Drug) In Overweight And Obese Male And Female Subjects
Double-Blind, Randomized, Placebo-Controlled Study Evaluating the
Safety, Tolerability, and Pharmacokinetics of Single- and Multiple-Doses of
(Study Drug) 1.5 mg Administered as a 4-hour Intravenous infusion and
(Study Drug) 2 g Administered as Either a 4-hour or 1-hour Intravenous
Infusion in Healthy Adults
A Single Dose Clinical Trial to Study the Safety, Tolerability,
Pharmacodynamics, and Pharmacokinetics of (Study Drug)
An Open-Label Study to Evaluate the Effects of (Study Drug) on the
Pharmacokinetics of (Study Drug) in Healthy Subjects
A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the
Safety, Tolerability, and Pharmacokinetics of Single Oral Doses of (Study
Drug) in Healthy Elderly Male and Healthy Elderly Female Subjects
An Open-Label, Partially Randomized, Single-Dose, 3-Period, Crossover
Biocomparison Study to Evaluate the Pharmacokinetic Profile of the Phase
I and Phase II Formulations of in Healthy Male Subjects
A Study to Evaluate the Definitive Bioequivalence of (Study Drug) with
Marketed
A Study to Assess the Safety, Tolerability, Pharmacokinetics and
Pharmacodynamics of (Study Drug) After Multiple Daily Administration in
Subjects With Type 2 Diabetes
A Multi-centered, Randomized, Double-Blind, Placebo-Controlled, Single
Dose Efficacy and Safety Study of (Study Drug) for Inhalation in
Schizophrenic Patients with Agitation
A Study to Assess the Effects of Co-Administration of (Study Drug) and
(Study Drug) on (Study Drug) Hormone Concentrations
A Single-Dose Study to Evaluate the Comparative Bioavailability of Four
Formulations of (Study Drug) in Subjects
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A Study to Evaluate the Effect of Multiple-Doses of (Study Drug) on the
Pharmacokinetics of Oral Contraceptives in Healthy Female Subjects
A Phase II, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging
Study of Fixed Doses of Oral (Study Drug) and (Study Drug) in the
Treatment of Outpatients with Moderate Depression
A Randomized, Double-Blind, Placebo-Controlled Parallel Study to Evaluate
the Effects of Estrogen on Estrogen Receptor Biomarkers in Healthy
Postmenopausal Women
A Single Dose Study to Assess the Bioavailability of (Study Drug)
A Multiple Dose Clinical Trial to Study the Safety, Tolerability,
Pharmacokinetics and Pharmacodynamics of (Study Drug)
A Randomized Clinical Trial to Evaluate the Effects of (Study Drug) on
(Study Drug) in Healthy Postmenopausal Women
Phase 1A Clinical Study with (Study Drug): Double-Blind, Randomized,
Placebo-Controlled, Single Dose Escalating Study in Healthy Adults
A Phase 1, Repeated-Dose, Open-Label, Study to Investigate the
Pharmacokinetics and Safety of (Study Drug) 750 mg bid Administered to
Patients with Impaired hepatic Function Compared to Matching Healthy
Subjects
Randomized Pilot Study to Assess the Relative Bioavailability of Three
Modified Release (MR) Formulations of (Study Drug) Compared to the
Immediate Release Formulation and to Assess the Effects of Food on the
Bioavailability of the XX Formulations in Healthy Subjects
A Randomized Open-label, Single-dose, Four-period Crossover Study to
Assess the Influence of Food on the Relative Bioavailability of a (Study
Drug) 20 mg Delayed-release [DR] Tablet and to Compare the 20 mg XX
Tablet to 35 mg XX s and 35 mg Immediate-release Tablets in
Postmenopausal Women
A Randomized, Partially-blinded, Single-rising-Dose, Multicenter, Parallel-
design, Phase I, Tolerability, and Pharmacokinetic Study of 3 Delayed-
release (Study Drug) Formulations Compared to a 150 mg Immediate-
release (Study Drug) Formulation in Normal Healthy Women Between the
Ages of 40-70
A Multi-center, Randomized, Double-blind, Two-treatment, Two-period, Two-
sequence, Crossover Study to Assess the Bioequivalence of the Phase III
WILLIAM GERSON, DO. CPI
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and Commercial (Study Drug) 35 mg Delayedrelease Formulations in
Healthy Male and Female Subjects
A Double-Blind Randomized Parallel Study to define the ECG effects of
(Study Drug) using a Clinical and Supratherapeutic Dose compared to
Placebo and (Study Drug) in Healthy volunteers: A Thorough ECG study
A Single-Dose, Randomized, Double-Blind, Double-Dummy, Placebo-
Controlled, Active-Comparator, Four-Way Crossover Study to Investigate
the Effect of (Study Drug) at a Projected Therapeutic and (Study Drug) Dose
on the QT/QTc Interval in Healthy Volunteers
A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-
Group, Multiple-Ascending-Dose Study to Investigate the Safety,
Tolerability, and Pharmacokinetics of (Study Drug) Following Intravenous
Infusion in Healthy Subjects.
A Double-Blind, Placebo-Controlled Study to Evaluate the Safety,
Tolerability, and Pharmacokinetics of Single, Escalating Oral Doses of
(Study Drug) in Healthy Male Subjects
A Randomized, Double-blind, Placebo-Controlled, Single-, Ascending-, Oral
Dose Safety, Tolerability and Pharmacokinetic Study of (Study Drug) in
Healthy Adult Human Male and Female Volunteers
A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose
Study of (Study Drug) in Subjects with Genotype 1 Chronic Hepatitis C
An Evaluation of the Relative Bioavailability of Testosterone at Steady State
from Two 70 cm2 Testosterone Matrix (Study Drug) Systems in Males
Comparative Bioavailability of (Study Drug) 1000DC/40 mg (Study Drug)
Tablets versus (Study Drug) 500WG/20 mg Study Drug) Tablets
Administered as a Single2000/80 mg dose
A Phase 1, Randomized, Double-blind, Placebo-controlled, Multiple
Ascending Dose Study Evaluating the Safety, Tolerability
and Pharmacokinetics of (Study Drug) Administered for Two Weeks in
Healthy Subjects and Subjects with Type 2 Diabetes
2006
A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel Group
Study Evaluating the Efficacy and Safety of (Study Drug) Administered
Daily for Four Weeks in Subjects with Low HDL-C Levels
An Open-label, Single-dose Study of the Pharmacokinetics of (Study Drug)
in Subjects With Various Degrees of Renal Function
WILLIAM GERSON, DO. CPI
Page 17 of 21
A Randomized, Double-blind, Placebo-controlled, Ascending Multiple Dose
Study to Evaluate the Safety, Tolerability, Pharmacokinetics and
Pharmacodynamics of (Study Drug) in Postmenopausal Women with Low
Bone Mass
An Open-Label, Parallel-Group Study to Assess the Effect of Age on the
Pharmacokinetics and Safety (Study Drug) in Healthy Subjects
An Open-Label Clinical Trial of the Safety and Pharmacokinetics of Single
Escalating Doses of (Study Drug) in Healthy Volunteers
A Multiple-Dose, Open-Label Study Evaluating the Pharmacokinetics of a
(Study Drug) Capsule at Steady-State in Healthy Human Subjects
An open label, single-sequence, repeat-dose study to investigate the
effects of (Study Drug) on the pharmacokinetics of an oral contraceptive
pill when given to healthy female volunteers
An open-label, randomized, single dose, four-treatment crossover study to
evaluate platelet function in healthy adult male volunteers following
administration of intravenous sodium (Study Drug mg), oral potassium
(Study Drug mg), intravenous (Study Drug) 30 mg and acetylsalicylic acid
(325 mg)
An Open-Label, Single Center, Single-Dose Study to Assess the Effects of
Age, Weight, and Body Composition on the Pharmacokinetic Profile, Safety,
and Tolerability of Intravenous (Study Drug) Sodium in Adult Volunteers
A double-blind, randomized, placebo-controlled, sequential cohort study to
evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics
of multiple ascending oral doses of (Study Drug) in otherwise healthy
obese male and female subjects"
A Double-Blind, Randomized, Placebo- Controlled, Sequential Group Study
to Evaluate the Safety, Tolerability and Pharmacokinetics of Single
Ascending Doses of (Study Drug) in Healthy Female Subjects
Double-blind, randomized, placebo-controlled study evaluating the safety,
tolerability, and pharmacokinetics of single- and multiple-doses of 2-g
(Study Drug) administered as either a 4-hour or 1-hour intravenous infusion
in healthy adults
An Open-Label, Randomized, Single-Dose, 2-Period Crossover Study to
Evaluate the Comparative Bioavailability of Two Formulations of (Study
Drug) Dry Filled Capsules in the Fasted State with a Fixed Period to
WILLIAM GERSON, DO. CPI
Page 18 of 21
Evaluate the Effect of a High and Low-Fat Meal in Healthy Young Male
Subjects
A Double-Blind, Randomized, Placebo Controlled Study to Assess the
Safety, Tolerability, and Pharmacokinetics of Multiple Doses of ( Study Drug)
in Healthy, Young, Male Volunteers
A Randomized, Double-Blind, Placebo Controlled, 2-Period Fixed-Sequence
Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of
Orally Administered (Study Drug) in Patients during and between their
Acute Migraine Attacks
A Double-Blind, Randomized, Placebo-Controlled, Single and Divided
Rising-Dose, Sequential Panel Study to Assess the Safety, Tolerability,
Pharmacokinetics and Pharmacodynamics of (Study Drug) in Subjects with
Type 2 Diabetes
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Sequential
Panel Study to Assess the Safety, Tolerability, Pharmacokinetics and
Pharmacodynamics of (Study Drug) After Multiple Daily Administration of
(Study Drug) Before Each Meal (q.a.c.) or Before Two Meals (b.i.d. a.c.) in
Subjects With Type 2 Diabetes
A Multicenter, 2-Part, Randomized, Double-Blind, Placebo-Controlled,
Multiple-Dose Study to Assess the Safety, Tolerability, Pharmacokinetics
and Phamacodynamics of (Study Drug) on Postprandial Plasma Glucose
Concentrations After Daily Administration of (Study Drug) Before Each
Meal (q.a.c.) in Subjects With Type 2 Diabetes Being Treated With Basal
Insulin
A Randomized, Double-Blind, Placebo-Controlled, 4-Period, Crossover
Study to Evaluate the Effects of (Study Drug), and Placebo on Urinary
Metabolites in Subjects with Hypercholesterolemia
A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the
Safety, Tolerability, and Pharmacokinetics of a Single Oral Dose of (Study
Drug) in Healthy Elderly Male and Elderly Female Volunteers
A 3-Part, Open-Label, Randomized, 2-Period Crossover Study to
Demonstrate the Definitive Bioequivalence After Administration of the Final
Market Image (Study Drug) 50-mg/500-mg, 50-mg/850-mg, and 50-mg/1000-
mg Fixed-Dose Combination (Study Drug) Tablet and Co-administration of
Corresponding Doses of (Study Drug) and (Study Drug) as Individual
Tablets to Healthy Adult Subjects
An Open-Label, Multi-Part, Multi-Panel, Randomized, Multi-Period, Partially
Fixed-Sequence, Crossover Study to Evaluate the Comparative
WILLIAM GERSON, DO. CPI
Page 19 of 21
Bioavailability of Three Formulations of (Study Drug) in the Fasted State
and in the Fed State in Healthy Young Subjects
A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single
Oral Dose of (Study Drug) in Healthy Elderly Male, Elderly Female, and
Young Female Volunteers
A Randomized, Double-Blind, Double Dummy, Placebo-Controlled, Multiple-
Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and
Pharmacodynamic Efficacy of (Study Drug) and (Study Drug) in Healthy
Postmenopausal Women
The Pharmacokinetics and Safety of a Single Dose of (Study Drug)
Administered With and Without Food in Healthy Volunteers
A Phase Ib/IIa Multiple-Dose, Double-Blind, Randomized, Placebo-
Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and
Pharmacodynamics of (Study Drug) in Subjects with Mild to Moderate
Atopic Dermatitis
A Randomized Open-label, Single-dose, Four-period Crossover Study to
Assess the Influence of a High-fat Meal on the Relative Bioavailability of a
35 mg Delayed-release Formulation of (Study Drug) Compared to the Same
35 mg Delayed-release Formulation Under Fasted Conditions and a 35 mg
(Study Drug)-release Formulation Administered Fasted or 30 Minutes Prior
to a High-fat Meal in Postmenopausal Women
An Open-label, Multiple-dose, Randomized, Two-period Crossover Study to
Assess Bioequivalence of the 300 mcg/day (Study Drug) Reduced-size
(Study Drug) (14 cm2) Relative to the 300 mcg/day (Study Drug) Reference
(Study Drug) (28 cm2) in Healthy Postmenopausal Women
A Randomized Open-label, Single-dose, Four-period Crossover Study to
Assess the Influence of a High-fat Meal on the Relative Bioavailability of a
35 mg Delayed-release Formulation of (Study Drug) Compared to the Same
35 mg Delayed-release Formulation Under Fasted Conditions and a 35 mg
(Study Drug) -release Formulation Administered Fasted or 30 Minutes Prior
to a High-fat Meal in Postmenopausal Women
A randomized, open-label, 2-period, crossover study to assess the
bioequivalence of one150 mg (Study Drug) tablet versus two 75 mg (Study
Drug) tablets administered as a single oral dose in healthy male and female
subjects
WILLIAM GERSON, DO. CPI
Page 20 of 21
A Phase I, open-label trial to investigate the pharmacokinetic interaction
between (Study Drug) and (Study Drug) both at steady-state in healthy
subjects."
2005
A double blind, randomized, placebo-controlled study of the safety and
pharmacokinetics of repeated oral doses of (Study Drug), administered
either QD (0.15, 0.5 and 1 mg) or BID (0.5 or 1 mg) for 14 days to elderly
male and female subjects
A Study to Investigate the Influence of (Study Drug) on the
Pharmacokinetics of (Study Drug) in Healthy Male Subjects
A Phase II, 28-day, Partially-blinded, Multicenter, Randomized, Parallel-
group Study to Evaluate 200 and 300μg Daily (Study Drug) Compared to
Daily (Study Drug) on Bone Turnover Markers, Pharmacokinetics, and
Safety in Postmenopausal Women
A Randomized, Open-Label, Crossover Study to Assess the Influence of
(Study Drug) on the Relative Bioavailability of 35 mg Delayed-release
Formulation of (Study Drug) in Postmenopausal Women.
An Observer-Blind, Parallel-Group Study To Evaluate Gastrointestinal
Tolerability And Amoxicillin Pharmacokinetics After Oral Administration Of
X Gram Amoxicillin (Immediate Release) Powder For Oral Suspension
Versus X Gram (Study Drug) XR® Tablets Twice Daily For Seven Days In
Healthy Adult Subjects.
A Phase I, Double-Blind, Placebo-Controlled, CCCC Active-Controlled,
Daily-Dose, Safety And Tolerance Study Of (Study Drug) Soft Gel Capsules
In Normal Healthy Postmenopausal Women.
A Study To Assess The Effects On Electrocardiograms, Tolerance, And
Safety Of Multiple Doses Of (Study Drug) Modified Release Formulation In
Healthy Volunteers.
A Phase 1, Open Label, Multiple Dose, Parallel Group Study To Evaluate
The Pharmacokinetics And Lipid Effects Of Evening Of Morning
Administration Of Fixed Combination (Study Drug) Administered To Healthy
Adult Subjects.
A Phase 1, Open-Label, Multiple Dose Study To Evaluate The
Pharmacokinetics, Lipid Effects, Safety, And Tolerability Of The Fixed
Combination Of (Study Drug) Administered To Subjects With Impaired And
Normal Renal Function.
WILLIAM GERSON, DO. CPI
Page 21 of 21
A Phase 2, Randomized Double –Blind, Placebo-Controlled Study To
Examine The Safety And Pharmacokinetics Of (Study Drug) In Subjects
With Type 2 Diabetes Mellitus.
A Single-Blind, 2-Period Crossover, Study To Evaluate The Pharmacokinetic
Interaction Of Multiple Doses Of (Study Drug) And (Study Drug) In Healthy
Subjects.
A Double-Blind, Placebo Controlled, Randomized, Multi-Dose Study To
Assess The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics
Of (Study Drug) Administered Orally For 7 Days In Adult Subjects With Type
2 Diabetes.
A Randomized, Double-Blind, Placebo Study Assessing The Efficacy,
Safety, And Pharmacokinetics Of (Study Drug), A Progesterone Receptor
Modulator, In The Inhibition Of Ovulation In Healthy Ovulatory Women.
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