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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: Completed Phase 1 study, sponsored by VIVUS.
NCT00768209 is a Phase 1 study that has completed, run by VIVUS. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
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
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2008-10 |
| Est. Completion | 2009-07 |
| Phase | Phase 1 |
What the finished NCT00768209 record still lists
NCT00768209 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 1 intervention - of which Phentermine and Topiramate is the first listed.
NCT00768209 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00768209's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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