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NCT00768209 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by VIVUS.

Completed
Registry status
Phase 1
Development phase
18
Enrollment target

NCT00768209 is a Phase 1 study that has completed, run by VIVUS. The registered enrollment target is 18 participants.

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The verdict

NCT00768209, a Phase 1 study, has completed, sponsored by VIVUS.

COMPLETED
Registry status
Phase 1
Development phase
18 participants
Enrollment target

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.

Interventions

  • DRUG Phentermine and Topiramate

Trial Details

FieldValue
Enrollment Target 18 participants
Start Date 2008-10
Est. Completion 2009-07
Phase Phase 1

Sponsor

VIVUS

35 total trials

What the Registry Record Tells You About NCT00768209

The ClinicalTrials.gov registry entry for NCT00768209 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VIVUS, which has 35 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Phentermine and Topiramate is the first listed.

NCT00768209 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00768209 about?

NCT00768209 is a clinical study titled "A Study to Evaluate the Pharmacokinetics of VI-0521 in Subjects With Hepatic Impairment". 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.

What is the current status of trial NCT00768209?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2008-10. Estimated completion is 2009-07.

What interventions are being tested in trial NCT00768209?

The interventions under investigation include: Phentermine and Topiramate (DRUG).

Who is sponsoring clinical trial NCT00768209?

This trial is sponsored by VIVUS, which has 35 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.