NCT01761773

A Single-Dose Study to Assess the Pharmacokinetics of Cabozantinib (XL184) Capsules in Subjects With Impaired Renal Function

A Phase 1, Open-Label, Parallel-Cohort, Single-Dose Study to Assess the Pharmacokinetics of Cabozantinib (XL184) Capsules in Subjects With Impaired Renal Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Exelixis · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy
• Renal Impairment

Interventions

Type	Name	Description
DRUG	cabozantinib	3 20-mg strength capsules (60 mg dose) administered as a single oral dose on Day 1 of study participation.

Timeline

• Start date: 2012-12-01
• Primary completion: 2013-04-01
• Completion: 2014-07-01
• First posted: 2013-01-07
• Last updated: 2014-09-22

Locations

3 sites across 1 country: United States