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NCT01761773 · ClinicalTrials.gov registry record · Phase 1
A Single-Dose Study to Assess the Pharmacokinetics of Cabozantinib (XL184) Capsules in Subjects With Impaired Renal Function
A Phase 1 study of Healthy and Renal Impairment, sponsored by Exelixis.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
- 3
- Study locations
NCT01761773: Completed Phase 1 study of Healthy and Renal Impairment, sponsored by Exelixis.
NCT01761773 is a Phase 1 study of Healthy and Renal Impairment that has completed, run by Exelixis. The registered enrollment target is 32 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (95% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01761773, a Phase 1 study of Healthy and Renal Impairment, has completed, sponsored by Exelixis.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
- 3
- Study locations
Study Summary
The main objective of the trial is to compare the pharmacokinetics of a 60 mg dose of cabozantinib in adult subjects with impaired renal function compared with healthy adult subjects. Another objective is to assess the safety and tolerability of cabozantinib in these adult subjects.
Primary Outcome
AUC, Cmax, tmax, kel, t1/2, CL/F, V/F and fu as measure of a single oral 60 mg dose of cabozantinib in adults with impaired renal function compared with healthy subjects matched for age, gender, and body mass index (BMI). Subjects will receive a single oral 60 mg dose of cabozantinib on Day 1 and then undergo periodic assessments Days 1 - 8 following this single dose, as well as on the mornings of Days 11, 13, 15, 18, 21, 22.
Conditions Studied
Interventions
- DRUG cabozantinib
Study Locations (3)
Florida
- - Miami
- - Orlando
New Jersey
- - Neptune City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2012-12 |
| Est. Completion | 2014-07 |
| Phase | Phase 1 |
What the finished NCT01761773 record still lists
NCT01761773 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (95% lower).
The record links to 2 conditions, with Healthy appearing as the primary indexed condition, and to 1 intervention - of which cabozantinib is the first listed.
NCT01761773 reports a single indexed study location in Florida, New Jersey.
Frequently Asked Questions
What is clinical trial NCT01761773 about?
NCT01761773 is a clinical study titled "A Single-Dose Study to Assess the Pharmacokinetics of Cabozantinib (XL184) Capsules in Subjects With Impaired Renal Function". The main objective of the trial is to compare the pharmacokinetics of a 60 mg dose of cabozantinib in adult subjects with impaired renal function compared with 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 NCT01761773?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2012-12. Estimated completion is 2014-07.
What conditions does trial NCT01761773 study?
This clinical trial studies the following conditions: Healthy, Renal Impairment.
What interventions are being tested in trial NCT01761773?
The interventions under investigation include: cabozantinib (DRUG).
Who is sponsoring clinical trial NCT01761773?
This trial is sponsored by Exelixis, which has 48 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01761773 being conducted?
This trial has 3 study locations across Florida, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01761773's enrollment target sits among peer trials
32 647th of 1090 higher than 418 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy 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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