Conditions: Obesity
Keywords: Renal function Glomerular Filtration Rate Kidney function Qsymia Iohexol Serum Creatinine Creatinine clearance Renal Clearance VI-0521 Healthy volunteers
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 51
Healthy volunteers: yes

Brief summary:
The main purpose of this study is measure the effect of VI-0521 on kidney function. Specifically, glomerular filtration rate (GFR) will be measured at baseline, after 4 weeks of study treatment, and after an additional 4 weeks of off-treatment recovery.

Detailed description:
This is a randomized, double-blind, placebo-controlled, single-site study in healthy overweight or obese male and female volunteers. Oral VI-0521 (combination of phentermine and topiramate \[PHEN/TPM\] extended-release capsule) will be administered daily as follows:

* Days 1-3: PHEN/TPM 3.75 mg /23 mg
* Days 4-6: PHEN/TPM 7.5 mg /46 mg
* Days 7-9: PHEN/TPM 11.25 mg /69 mg
* Days 10-28: PHEN/TPM 15 mg /92 mg

A single dose of Iohexol (a non-radioactive iodine-containing contrast agent) will be administered intravenously on three separate occasions.

The study will include a total of 50 healthy subjects (40 active and 10 placebo), all of whom will have overnight stays on 3 separate occasions.

Total study duration is approximately 10 weeks (2 weeks screening, 4 weeks study treatment, 4 weeks post treatment follow up).

Arms:
arm 1: * Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
* Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
* Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)
* Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg) arm 2: Days 1-28: Placebo

Interventions: intervention 1: Qsymia intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: