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

Completed · Phase 1

Conditions studied: Healthy, Hepatic Impairment

In brief

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.

Key facts

Study ID

NCT01493869

Run by

Exelixis

People needed

26

Starts

2011-09-01

Expected to finish

2014-08-01

Last updated by the study team

2014-09-22

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Body weight must be ≥50 kg and <130 kg with a BMI of ≥18 (kg/m2) and ≤36.0 (kg/m2).
• Must use acceptable forms of birth control during the course of the study and for 3 months following the single dose of study drug.
• Female subjects of childbearing potential must have a negative pregnancy test at screening and check-in.
• Must have adequate vital sign reads at screening and check-in.
• Must be able to comply with dietary and fluid restrictions required for the study

Where it is running

• McGuire VA Medical Center — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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