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Completed Phase 1 Interventional Accepts healthy volunteers

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

ClinicalTrials.gov ID: NCT00768209

Public ClinicalTrials.gov record NCT00768209. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 4:26 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00768209
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
VIVUS LLC
Industry
Enrollment
18 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 65 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 30, 2008
Primary completion
Feb 28, 2009
Completion
Jun 30, 2009
Last update posted
Nov 30, 2009

2008 – 2009

United States locations

U.S. sites
2
U.S. states
1
U.S. cities
2
Facility City State ZIP Site status
Clinical Pharmacology of Miami Miami Florida 33014-3616
Orlando Clinical Research Center Orlando Florida 32809-3017

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00768209, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 30, 2009 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00768209 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →