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A Bioequivalence Study Of AG-013736 Tablets In Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00905814
First received: May 20, 2009
Last updated: November 13, 2009
Last verified: November 2009
  Purpose

The hypothesis of this study is that one 5 mg tablet of axitinib has similar drug concentrations in plasma compared to five 1 mg tablets of axitinib after oral dosing.


Condition Intervention Phase
Healthy Volunteers
Drug: AG-013736
Drug: AG-103736
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Phase I Bioequivalence Study To Compare The Plasma Pharmacokinetics Of Five 1-mg And One 5-mg AG-013736 Tablets In Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • To establish bioequivalence of five 1 mg film coated immediate release (FCIR) tablets of AG-013736 to one 5 mg FCIR tablet of AG-013736. [ Time Frame: 3 days per period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the safety and tolerability of single dose AG-013736 when administered as five 1 mg FCIR tablets and one 5 mg FCIR tablet. [ Time Frame: 3 days per period ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: July 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sequence 1 (BABA)
Treatment A: One 5-mg FCIR tablet Treatment B: Five 1-mg FCIR tablets Subjects in this sequence will participate in 4 periods in the following order: B -> A -> B -> A
Drug: AG-013736
single oral dose of film coated immediate release tablet (one 5-mg tablet for Treatment A and five 1-mg tablets for Treatment B)
Other Name: axitinib
Sequence 2 (ABAB)
Treatment A: One 5-mg FCIR tablet Treatment B: Five 1-mg FCIR tablets Subjects in this sequence will participate in 4 periods in the following order: A -> B -> A -> B
Drug: AG-103736
single oral dose of film coated immediate release tablet (one 5-mg tablet for Treatment A and five 1-mg tablets for Treatment B)
Other Name: axitinib

  Eligibility

Ages Eligible for Study:   21 Years to 47 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male and/or female subjects between the ages of 21 and 47 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 electrocardiogram (ECG) and clinical laboratory tests).
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
  • An informed consent document signed and dated by the subject or a legally acceptable representative.

Exclusion Criteria:

  • Evidence of significant disease of the blood, kidney, endocrine system, lungs, gastrointestinal, heart, liver, psychiatric, neurologic, or allergic (including drug allergies, but excluding season allergies).
  • Active smokers or users of tobacco containing products and other drugs
  • Pregnant or nursing females; females of childbearing potential including those with tubal ligation.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00905814

Locations
Singapore
Pfizer Investigational Site
Singapore, Singapore, 188770
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00905814     History of Changes
Other Study ID Numbers: A4061052
Study First Received: May 20, 2009
Last Updated: November 13, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Bioequivalence

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

ClinicalTrials.gov processed this record on November 25, 2014