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

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

Study Description
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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
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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

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Arms and Interventions
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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
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Primary Outcome Measures :
  1. Pharmacokinetic parameters [ Time Frame: One month ]

Eligibility Criteria
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00518466


Locations
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United States, California
VIVUS, Inc.
Mountain View, California, United States, 94040
Sponsors and Collaborators
VIVUS, Inc.
Investigators
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Study Director: Wesley W Day, PhD VIVUS, Inc.
More Information
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Responsible Party: Wesley Day, VP Clinical, Vivus, Inc.
ClinicalTrials.gov Identifier: NCT00518466     History of Changes
Other Study ID Numbers: OB-102 / AA42851
First Posted: August 20, 2007    Key Record Dates
Last Update Posted: June 8, 2011
Last Verified: June 2011

Keywords provided by VIVUS, Inc.:
Obesity

Additional relevant MeSH terms:
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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