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NCT01493869 · ClinicalTrials.gov registry record · Phase 1
Study to Assess the Pharmacokinetics of Cabozantinib (XL184) in Hepatic Impaired Adult Subjects
A Phase 1 study, sponsored by Exelixis.
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
NCT01493869: Completed Phase 1 study, sponsored by Exelixis.
NCT01493869 is a Phase 1 study that has completed, run by Exelixis. The registered enrollment target is 26 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01493869, a Phase 1 study, has completed, sponsored by Exelixis.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
Study Summary
The main objective of this study is to compare the pharmacokinetics (PK) of a single oral 75 mg dose of cabozantinib in hepatic impaired adult subjects to healthy adult subjects. Another objective is to assess the safety and tolerability of cabozantinib in these adult subjects.
Primary Outcome
Subjects will receive a single oral 75 mg dose of cabozantinib on Day 1 and then undergo periodic assessments Days 1 through 5 following this single dose, as well as on the mornings of Days 6, 8, 11, 15, 19, 21, and 22.
Interventions
- DRUG cabozantinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2011-09 |
| Est. Completion | 2014-08 |
| Phase | Phase 1 |
What the finished NCT01493869 record still lists
NCT01493869 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 1 intervention - of which cabozantinib is the first listed.
NCT01493869 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01493869 about?
NCT01493869 is a clinical study titled "Study to Assess the Pharmacokinetics of Cabozantinib (XL184) in Hepatic Impaired Adult Subjects". The main objective of this study is to compare the pharmacokinetics (PK) of a single oral 75 mg dose of cabozantinib in hepatic impaired adult subjects to healthy adult subjects. Another objective is to assess the safety and tolerability of cabozantinib in these adult subjects.
What is the current status of trial NCT01493869?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2011-09. Estimated completion is 2014-08.
What interventions are being tested in trial NCT01493869?
The interventions under investigation include: cabozantinib (DRUG).
Who is sponsoring clinical trial NCT01493869?
This trial is sponsored by Exelixis, which has 48 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01493869's enrollment target sits among peer trials
26 1482nd of 2000 higher than 506 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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