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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
Sponsor:
Information provided by:

Study Description
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).


Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: AG-013736 (axitinib) Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Non-Randomized
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
Primary Completion Date : August 2009
Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Axitinib
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. Plasma Pharmacokinetics of AG-013736 in Chinese Healthy Volunteers [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Safety of AG-013736 in Chinese Healthy Volunteers [ Time Frame: 3 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

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


Locations
China
Pfizer Investigational Site
Beijng, China, 100730
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00919204     History of Changes
Other Study ID Numbers: A4061050
First Posted: June 12, 2009    Key Record Dates
Last Update Posted: September 21, 2009
Last Verified: September 2009

Keywords provided by Pfizer:
AG-013736, axitinib, pharmacokinetics, healthy, Chinese

Additional relevant MeSH terms:
Axitinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action