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An Open Label Phase 1 Study To Evaluate The Pharmacokinetics Of AG-013736 In Healthy Chinese Volunteers

Phase 1
18 Years
45 Years
Not Enrolling
Healthy Volunteers

Thank you

Trial Information

An Open Label Phase 1 Study To Evaluate The Pharmacokinetics Of AG-013736 In Healthy Chinese Volunteers

Inclusion Criteria:

- Healthy male and/or female (of nonchildbearing potential) Chinese (individuals
currently residing in mainland China who were born in China and have both parents of
Chinese descent) subjects between the ages of 18 and 45 years, inclusive. (Healthy
is defined as no clinically relevant abnormalities identified by a detailed medical
history, full physical examination, including blood pressure and pulse rate
measurement, 12 lead ECG and clinical laboratory tests.)

- Body Mass Index (BMI) of 19 to 24 kg/m2; and a total body weight >50 kg (110 lbs). A
BMI lower limit of 18.5 kg/m2 may be rounded up to 19.0 kg/m2; a BMI upper limit of
24.5 kg/m2 may be rounded down to 24.0 kg/m2 and will be acceptable for inclusion.

Exclusion Criteria:

- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal
allergies at time of dosing) disease or clinical findings at Screening.

- Any condition possibly affecting drug absorption (eg, gastrectomy).

- Drug dependency, a positive urine drug screen, or alcohol dependency.

- History of regular alcohol consumption exceeding 28 or more units per week. (One
unit=285 mL of beer or 25 mL of spirits or 125 mL of wine).

- Use of tobacco- or nicotine-containing products (or a positive urine cotinine test).

- Treatment with an investigational drug within 3 months (or as determined by local
regulations) or 5 half-lives preceding the first dose of study medication.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Plasma Pharmacokinetics of AG-013736 in Chinese Healthy Volunteers

Outcome Time Frame:

3 months

Safety Issue:


Principal Investigator

Pfizer Call Center

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

August 2009

Completion Date:

August 2009

Related Keywords:

  • Healthy Volunteers
  • AG-013736, axitinib, pharmacokinetics, healthy, Chinese