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

Launched by EXELIXIS · Jan 4, 2013

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Gender

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Eligibility 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.