Pharmacokinetic Comparison of Multiple Formulations of Topiramate and Phentermine in Obese Adults

• ClinicalTrials.gov Identifier: NCT00518466
• Recruitment Status: Completed
• First Posted: August 20, 2007
• Last Update Posted: June 8, 2011
• Sponsor: VIVUS LLC
• Information provided by: VIVUS LLC

Study Description

Brief Summary:

The primary objective of this study is to describe the single- and multiple-dose pharmacokinetic profiles of two novel formulations of topiramate and commercially available immediate release topiramate, all dosed with immediate release phentermine.

Condition or disease	Intervention/treatment	Phase
Obesity	Drug: topiramate; Drug: phentermine	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 64 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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 Start Date: July 2007
• Actual Primary Completion Date: September 2007
• Actual Study Completion Date: December 2007

Arms and Interventions

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.	Drug: topiramate; 25 mg modified-release capsules; Drug: phentermine; 7.5 mg immediate-release capsules
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.	Drug: topiramate; 25 mg modified-release capsules; Drug: phentermine; 7.5 mg immediate-release capsules
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.	Drug: topiramate; 25 mg modified-release capsules; Drug: phentermine; 7.5 mg immediate-release capsules
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.	Drug: topiramate; 100 and 25 mg immediate-release tablets; Drug: phentermine; 37.5 and 7.5 mg immediate-release tablets

Outcome Measures

Primary Outcome Measures :

1. Pharmacokinetic parameters [ Time Frame: One month ]

Eligibility Criteria

• Ages Eligible for Study: 19 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, California

VIVUS, Inc.

Mountain View, California, United States, 94040

Sponsors and Collaborators

VIVUS LLC

Investigators

• Study Director: Wesley W Day, PhD; VIVUS LLC

More Information

• Responsible Party: Wesley Day, VP Clinical, Vivus, Inc.
• ClinicalTrials.gov Identifier: NCT00518466
• Other Study ID Numbers: OB-102 / AA42851
• First Posted: August 20, 2007
• Last Update Posted: June 8, 2011
• Last Verified: June 2011

Keywords provided by VIVUS LLC:

Obesity

Additional relevant MeSH terms:

Obesity; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Topiramate; Phentermine; Anticonvulsants; Hypoglycemic Agents; Physiological Effects of Drugs; Central Nervous System Stimulants; Appetite Depressants; Anti-Obesity Agents; Sympathomimetics; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action