- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00518466
Pharmacokinetic Comparison of Multiple Formulations of Topiramate and Phentermine in Obese Adults
A Phase Ib, Open Label, Parallel-Design Single- and Multiple-Dose Study Comparing Modified Release Topiramate Formulations to Immediate Release Formulations of Topiramate Dosed in Combination With Immediate Release Phentermine in Obese Adults
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
California
-
Mountain View, California, United States, 94040
- Vivus, Inc.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Obese adults
- Body mass index between 30.0 and 42.0 kg/m2 (inclusive)
- Medically healthy with no clinically significant results of screening exams
Exclusion Criteria:
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease
- History of glaucoma or increased intraocular pressure
- History of kidney stones
- Cholelithiasis or cholecystitis within 6 months
- Cardiovascular event within 6 months
- Obesity of known genetic or endocrine origin
- Recent weight instability
- Use of Very Low Calorie diet or participation in organized weight loss program within 3 months
- Systolic blood pressure > 150 or diastolic > 95 mm Hg
- Positive urine drug or alcohol screen
- Positive serology for HIV, HBV, or HCV
- History of alcoholism or drug abuse
- History of significant psychiatric disease, current depression of moderate or greater severity, any history of suicidal ideation
- Hypersensitivity to study drug or related compounds
- Use of prescription or OTC medication other than hormonal contraceptive within 14 days prior to first dosing with study drug
- Blood donation or significant blood loss within 56 days or plasma donation within 7 days prior to first dosing with study drug
- Women who are pregnant or lactating
- Hemoglobin < 12 g/dL
- Use of tobacco or nicotine-containing products within 6 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: treatment 1
One 7.5 mg phentermine hydrochloride IR capsule and two 25 mg topiramate MR capsules at Hour 0 on Day 1 of Period 1. One 7.5 mg phentermine hydrochloride IR capsule and one 25 mg topiramate MR capsule at Hour 0 on Days 1, 2, and 3 of Period 2. One 7.5 mg phentermine hydrochloride IR capsule and two 25 mg topiramate MR capsules at Hour 0 on Days 4 - 21 of Period 2. |
25 mg modified-release capsules
7.5 mg immediate-release capsules
100 and 25 mg immediate-release tablets
37.5 and 7.5 mg immediate-release tablets
|
Experimental: treatment 2
Two 7.5 mg phentermine hydrochloride IR capsules and four 25 mg topiramate MR capsules at Hour 0 on Day 1 of Period 1. One 7.5 mg phentermine hydrochloride IR capsule and one 25 mg topiramate MR capsule at Hour 0 on Days 1, 2, and 3 of Period 2. One 7.5 mg phentermine hydrochloride IR capsules and two 25 mg topiramate MR capsules at Hour 0 on Days 4, 5, and 6 of Period 2. Two 7.5 mg phentermine hydrochloride IR capsules (Cardinal) and three 25 mg topiramate MR capsules at Hour 0 on Days 7, 8, and 9 of Period 2. Two 7.5 mg phentermine hydrochloride IR capsules and four 25 mg topiramate MR capsules at Hour 0 on Days 10 - 21 of Period 2. |
25 mg modified-release capsules
7.5 mg immediate-release capsules
100 and 25 mg immediate-release tablets
37.5 and 7.5 mg immediate-release tablets
|
Experimental: treatment 3
Two 7.5 mg phentermine hydrochloride IR capsules and four 25 mg topiramate MR capsules at Hour 0 on Day 1 of Period 1. One 7.5 mg phentermine hydrochloride IR capsule and one 25 mg topiramate MR capsule at Hour 0 on Days 1, 2, and 3 of Period 2. Two 7.5 mg phentermine hydrochloride IR capsules and two 25 mg topiramate MR capsule at Hour 0 on Days 4, 5, and 6 of Period 2. Two 7.5 mg phentermine hydrochloride IR capsules and three 25 mg topiramate MR capsules at Hour 0 on Days 7, 8, and 9 of Period 2. Two 7.5 mg phentermine hydrochloride IR capsules and four 25 mg topiramate MR capsules at Hour 0 on Days 10 - 21 of Period 2. |
25 mg modified-release capsules
7.5 mg immediate-release capsules
100 and 25 mg immediate-release tablets
37.5 and 7.5 mg immediate-release tablets
|
Experimental: treatment 4
Half of a 37.5 mg phentermine hydrochloride IR tablet and one 100 mg topiramate IR tablet at Hour 0 on Day 1 of Period 1. One 7.5 mg phentermine hydrochloride IR capsule and one 25 mg topiramate IR tablet at Hour 0 on Days 1, 2, and 3 of Period 2. Half of a 37.5 mg phentermine hydrochloride IR tablet and two 25 mg topiramate IR tablets at Hour 0 on Days 4, 5, and 6 of Period 2. Half of a 37.5 mg phentermine hydrochloride IR tablet and three 25 mg topiramate IR tablets at Hour 0 on Days 7, 8, and 9 of Period 2. Half of a 37.5 mg phentermine hydrochloride IR tablet and one 100 mg topiramate IR tablet at Hour 0 on Days 10 - 21 of Period 2. |
25 mg modified-release capsules
7.5 mg immediate-release capsules
100 and 25 mg immediate-release tablets
37.5 and 7.5 mg immediate-release tablets
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pharmacokinetic parameters
Time Frame: One month
|
One month
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Wesley W Day, PhD, VIVUS LLC
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Overnutrition
- Nutrition Disorders
- Overweight
- Body Weight
- Obesity
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Anticonvulsants
- Appetite Depressants
- Anti-Obesity Agents
- Central Nervous System Stimulants
- Sympathomimetics
- Topiramate
- Phentermine
Other Study ID Numbers
- OB-102 / AA42851
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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