Status:
COMPLETED
Study to Assess the Pharmacokinetics of Cabozantinib (XL184) in Hepatic Impaired Adult Subjects
Lead Sponsor:
Exelixis
Conditions:
Healthy
Hepatic Impairment
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief 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 ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01493869
Start Date
September 1 2011
End Date
August 1 2014
Last Update
September 22 2014
Active Locations (1)
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1
McGuire VA Medical Center
Richmond, Virginia, United States, 23249