Pharmacokinetic Comparison of Multiple Formulations of Topiramate and Phentermine in Obese Adults - Full Text View

Purpose

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	Intervention	Phase
Obesity	Drug: topiramate Drug: phentermine	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

Drug Information available for: Phentermine Phentermine hydrochloride Topiramate

U.S. FDA Resources

Further study details as provided by VIVUS, Inc.:

Primary Outcome Measures:

Pharmacokinetic parameters [ Time Frame: One month ]


Enrollment:	64
Study Start Date:	July 2007
Study Completion Date:	December 2007
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	19 Years to 65 Years (Adult)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00518466

Locations


United States, California
VIVUS, Inc.
Mountain View, California, United States, 94040

Sponsors and Collaborators

VIVUS, Inc.

Investigators


Study Director:	Wesley W Day, PhD	VIVUS, Inc.

More Information


Responsible Party:	Wesley Day, VP Clinical, Vivus, Inc.
ClinicalTrials.gov Identifier:	NCT00518466 History of Changes
Other Study ID Numbers:	OB-102 / AA42851
Study First Received:	August 16, 2007
Last Updated:	June 6, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by VIVUS, Inc.:


Obesity

Additional relevant MeSH terms:


Phentermine Topiramate Central Nervous System Stimulants Physiological Effects of Drugs Appetite Depressants Anti-Obesity Agents Sympathomimetics Autonomic Agents	Peripheral Nervous System Agents Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Anticonvulsants Neuroprotective Agents Protective Agents

ClinicalTrials.gov processed this record on September 30, 2016