Axitinib Pharmacokinetics in Chinese Healthy Volunteers

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00919204
• Other study ID #: A4061050
• Status: Completed
• Phase: Phase 1
• First received: June 11, 2009
• Last updated: September 17, 2009
• Start date: August 2009
• Est. completion date: August 2009

Study information

• Verified date: September 2009
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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.

Locations

Country	Name	City	State
China	Pfizer Investigational Site	Beijng

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma Pharmacokinetics of AG-013736 in Chinese Healthy Volunteers		3 months	No
Secondary	Safety of AG-013736 in Chinese Healthy Volunteers		3 months	Yes

External Links

•   To obtain contact information for a study center near you, click here.