NCT00768209

A Study to Evaluate the Pharmacokinetics of VI-0521 in Subjects With Hepatic Impairment

A Phase I, Open Label, Single-Dose Study to Evaluate the Pharmacokinetics of VI-0521 in Subjects With Hepatic Impairment and In Healthy Control Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: VIVUS LLC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study is designed to determine the effects of a single dose of the study medication in subjects with and without hepatic impairment. 18 to 24 subjects will participate by having multiple blood draws taken to measure the level of study medication in their blood over time.

Detailed description

This study will look at the effect of a single does of study medication in three groups. Each group will have 6 - 8 subjects with similar levels of hepatic impairment. Group 1 will have normal hepatic function. Groups 2 and 3 will be made up of subjects with mild to moderate hepatic impairment. Subjects will have blood taken at specific intervals to measure study medication levels. Subject participation will last approximately 7 to 9 days.

Conditions

• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	Phentermine and Topiramate	Each subject will be dosed with a single oral dose of VI-0521 (PHEN/TPM 15/92 mg).

Timeline

• Start date: 2008-10-01
• Primary completion: 2009-03-01
• Completion: 2009-07-01
• First posted: 2008-10-08
• Last updated: 2009-12-01

Locations

2 sites across 1 country: United States