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

NCT00768209 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2009-12-01

No results posted yet for this study

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.

Conditions

  • Hepatic Impairment

Interventions

DRUG

Phentermine and Topiramate

Each subject will be dosed with a single oral dose of VI-0521 (PHEN/TPM 15/92 mg).

Sponsors & Collaborators

  • Covance

    collaborator INDUSTRY

  • Sentrx

    collaborator INDUSTRY

  • VIVUS LLC

    lead INDUSTRY

Principal Investigators

  • Shiyin Yee, PhD · VIVUS LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2009-03-31
Completion
2009-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00768209 on ClinicalTrials.gov