Safety and Efficacy of Low Doses of V24343 in Obese Subjects
Summary
Randomised, double-blind, parallel group comparison of four dose levels of V24343 and placebo to study the effect of V24343 on blood pressure and weight in obese subjects. The primary variables, change in blood pressure (BP) and pulse, will be assessed both by outpatient ambulatory monitoring of vital signs and by regular clinic monitoring. The efficacy of V24343 will be assessed by measurement of body weight, waist circumference, bioimpedance assessment of body composition and blood glucose. Assay of plasma concentration of V24343 in blood samples collected at intervals after dosing will be used to assess the pharmacokinetics of V24343. Other safety assessments comprise routine monitoring of adverse events; concomitant medication; clinical laboratory safety tests, 12-lead electrocardiograms (ECG) and self-completed psychiatric assessments.
Timeline
- Start
- 2008-10
- Primary completion
- 2009-03
- Completion
- 2009-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | selonabant | Small molecule | 1 mg | Oral |
| Subject | selonabant | Small molecule | 2 mg | Oral |
| Subject | selonabant | Small molecule | 5 mg | Oral |
| Subject | selonabant | Small molecule | 25 mg | Oral |