Axitinib Pharmacokinetics in Chinese Healthy Volunteers
As part of the global clinical development program for AG-013736, studies are ongoing (and planned) in cancer patients in China. An assessment of AG-013736 pharmacokinetics in Chinese subjects, as required by the Chinese Health Authorities, is therefore warranted.
In the current study the single dose pharmacokinetics of AG-013736 will be characterized at 3 doses (5 mg, 7 mg and 10 mg).
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||An Open Label Phase 1 Study To Evaluate The Pharmacokinetics Of AG-013736 In Healthy Chinese Volunteers|
- Plasma Pharmacokinetics of AG-013736 in Chinese Healthy Volunteers [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Safety of AG-013736 in Chinese Healthy Volunteers [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2009|
|Study Completion Date:||August 2009|
|Primary Completion Date:||August 2009 (Final data collection date for primary outcome measure)|
|Experimental: Cohort 1||
Drug: AG-013736 (axitinib)
Three single oral-doses of AG-013736 (5-mg, 7-mg and 10-mg) will be successively administered (each separated by a washout period of at least 7 days) to healthy Chinese volunteers in the fed state.