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NCT01631097 · ClinicalTrials.gov registry record · Phase 1
A Single-Dose Study of Tivozanib in Subjects With Hepatic Impairment and Normal Hepatic Function
A Phase 1 study, sponsored by AVEO Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 44
- Enrollment target
NCT01631097: Completed Phase 1 study, sponsored by AVEO Pharmaceuticals.
NCT01631097 is a Phase 1 study that has completed, run by AVEO Pharmaceuticals. The registered enrollment target is 44 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01631097, a Phase 1 study, has completed, sponsored by AVEO Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 44 participants
- Enrollment target
Study Summary
This Phase 1, open-label, single dose study is designed to evaluate the pharmacokinetics, safety and tolerability of a single 1.5 mg tivozanib dose in subjects with varying degrees of hepatic impairment and normal hepatic function.
Interventions
- DRUG Tivozanib hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2012-05 |
| Est. Completion | 2014-01 |
| Phase | Phase 1 |
What the finished NCT01631097 record still lists
NCT01631097 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% lower).
The record links to 0 conditions, and to 1 intervention - of which Tivozanib hydrochloride is the first listed.
NCT01631097 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01631097 about?
NCT01631097 is a clinical study titled "A Single-Dose Study of Tivozanib in Subjects With Hepatic Impairment and Normal Hepatic Function". This Phase 1, open-label, single dose study is designed to evaluate the pharmacokinetics, safety and tolerability of a single 1.5 mg tivozanib dose in subjects with varying degrees of hepatic impairment and normal hepatic function.
What is the current status of trial NCT01631097?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 44 participants. The study started on 2012-05. Estimated completion is 2014-01.
What interventions are being tested in trial NCT01631097?
The interventions under investigation include: Tivozanib hydrochloride (DRUG).
Who is sponsoring clinical trial NCT01631097?
This trial is sponsored by AVEO Pharmaceuticals, which has 27 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01631097's enrollment target sits among peer trials
44 1086th of 2000 higher than 901 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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