Study to Assess the Pharmacokinetics of Cabozantinib (XL184) in Hepatic Impaired Adult Subjects
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Other |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 5/3/2014 |
| Start Date: | September 2011 |
| End Date: | December 2014 |
| Contact: | Exelixis Clinical Trials |
| Phone: | 1-888-393-5494 |
A Phase I, Open-Label, Parallel-Group, Single-Dose Study to Assess the Pharmacokinetics of XL184 (Cabozantinib) Capsules in Hepatic Impaired Adult Subjects
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.
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.
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
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