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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Obesity

Intervention / Treatment
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* Drug: topiramate
* Drug: phentermine
* Drug: topiramate
* Drug: phentermine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment 1<br>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<br>* 25 mg modified-release capsules<br>Drug: phentermine<br>* 7.5 mg immediate-release capsules<br>|
| Experimental: treatment 2<br>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<br>* 25 mg modified-release capsules<br>Drug: phentermine<br>* 7.5 mg immediate-release capsules<br>|
| Experimental: treatment 3<br>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<br>* 25 mg modified-release capsules<br>Drug: phentermine<br>* 7.5 mg immediate-release capsules<br>|
| Experimental: treatment 4<br>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<br>* 100 and 25 mg immediate-release tablets<br>Drug: phentermine<br>* 37.5 and 7.5 mg immediate-release tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameters |  | One month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity