Axitinib Pharmacokinetics in Chinese Healthy Volunteers
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|ClinicalTrials.gov Identifier: NCT00919204|
Recruitment Status : Completed
First Posted : June 12, 2009
Last Update Posted : September 21, 2009
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).
|Condition or disease||Intervention/treatment||Phase|
|Healthy Volunteers||Drug: AG-013736 (axitinib)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label Phase 1 Study To Evaluate The Pharmacokinetics Of AG-013736 In Healthy Chinese Volunteers|
|Study Start Date :||August 2009|
|Actual Primary Completion Date :||August 2009|
|Actual Study Completion Date :||August 2009|
|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.
- Plasma Pharmacokinetics of AG-013736 in Chinese Healthy Volunteers [ Time Frame: 3 months ]
- Safety of AG-013736 in Chinese Healthy Volunteers [ Time Frame: 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00919204
|Pfizer Investigational Site|
|Beijng, China, 100730|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|