Axitinib Pharmacokinetics in Chinese Healthy Volunteers

NCT00919204 | Completed Phase 1

• 1 other identifier: A4061050
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Healthy Volunteers

Keywords

AG-013736, axitinib, pharmacokinetics, healthy, Chinese

Outcome Measures

Primary Outcomes (1)

• Plasma Pharmacokinetics of AG-013736 in Chinese Healthy Volunteers

  3 months

Secondary Outcomes (1)

• Safety of AG-013736 in Chinese Healthy Volunteers

  3 months

Study Arms (1)

Cohort 1

EXPERIMENTAL

Drug: AG-013736 (axitinib)

Interventions

AG-013736 (axitinib) DRUG

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.

Cohort 1

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

Beijng, 100730, China

Location

Related Links

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

MeSH Terms

Interventions

Axitinib

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 11, 2009
• First Posted: June 12, 2009
• Study Start: August 1, 2009
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: September 21, 2009

Record last verified: 2009-09

Locations

CN (1)