NCT01493869

Study to Assess the Pharmacokinetics of Cabozantinib (XL184) in Hepatic Impaired Adult Subjects

A Phase I, Open-Label, Parallel-Group, Single-Dose Study to Assess the Pharmacokinetics of XL184 (Cabozantinib) Capsules in Hepatic Impaired Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Exelixis · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy
• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	cabozantinib	3 25-mg strength capsules (75-mg dose) administered as a single oral dose on Day 1 of study participation

Timeline

• Start date: 2011-09-01
• Primary completion: 2014-05-01
• Completion: 2014-08-01
• First posted: 2011-12-16
• Last updated: 2014-09-22

Locations

1 site across 1 country: United States