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NCT01316848 · ClinicalTrials.gov registry record · Phase 1

A Single Center, Open-label, Randomized, Two-period Crossover Food Effect Study of Single Doses of Tivozanib (AV-951) in Healthy Subjects

A Phase 1 study, sponsored by AVEO Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
30
Enrollment target

NCT01316848: Completed Phase 1 study, sponsored by AVEO Pharmaceuticals.

NCT01316848 is a Phase 1 study that has completed, run by AVEO Pharmaceuticals. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01316848, a Phase 1 study, has completed, sponsored by AVEO Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
30 participants
Enrollment target

Study Summary

This study will determine the effect of food on the pharmacokinetics (PK) of a single dose of 1.5 mg tivozanib in normal healthy subjects.

Primary Outcome

Blood samples for PK analysis of serum tivozanib levels will be collected for a 3-week period following each of 2 doses.

Interventions

  • DRUG tivozanib

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2011-02
Est. Completion 2011-05
Phase Phase 1
AVEO Pharmaceuticals

27 total trials

What the finished NCT01316848 record still lists

NCT01316848 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).

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

NCT01316848 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01316848 about?

NCT01316848 is a clinical study titled "A Single Center, Open-label, Randomized, Two-period Crossover Food Effect Study of Single Doses of Tivozanib (AV-951) in Healthy Subjects". This study will determine the effect of food on the pharmacokinetics (PK) of a single dose of 1.5 mg tivozanib in normal healthy subjects.

What is the current status of trial NCT01316848?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2011-02. Estimated completion is 2011-05.

What interventions are being tested in trial NCT01316848?

The interventions under investigation include: tivozanib (DRUG).

Who is sponsoring clinical trial NCT01316848?

This trial is sponsored by AVEO Pharmaceuticals, which has 27 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01316848's enrollment target sits among peer trials

30 1332nd of 2000 higher than 561 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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Source: ClinicalTrials.gov NCT01316848, the US trial registry maintained by the National Library of Medicine. NCT01316848 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.