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

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Exelixis

Criteria

Inclusion Criteria:

• Body weight must be ≥ 50 kg and < 130 kg with a BMI ≤ 38.0 (kg/m2).

• Must use acceptable form 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.

• Negative test for HIV; hepatitis A, B, and C.

• 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.

Exclusion Criteria:

• History of medical or surgical conditions that would interfere with GI absorption, distribution, metabolism, or excretion of the study drug.

• Recent clinical evidence of pancreatic injury.

• Recent use of drugs known to significantly inhibit or induce P450 CYP3A4 enzymes.

• Previous diagnosis of malignancy.

• Unwilling to forgo use of any over-the-counter or non-prescription preparations.