A Bioequivalence Study Of AG-013736 Tablets Under Fed Conditions In Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01020136
First received: November 23, 2009
Last updated: April 21, 2010
Last verified: April 2010
  Purpose

The purpose is to show that 5 mg Form IV tablet of AG-013736 produces similar drug concentrations in plasma compared to 5 mg Form XLI tablet of AG-013736 after oral dosing under fed conditions.


Condition Intervention Phase
Healthy Volunteer
Drug: AG-013736
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Phase 1 Bioequivalence Study To Compare The Plasma Pharmacokinetics Of AG-013736 Polymorph Form IV Versus Market-Image Polymorph Form XLI Tablets In Healthy Volunteers Under Fed Conditions

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • To establish the bioequivalence of test 5 mg market-image tablets of AG-013736 polymorph Form XLI to reference 5 mg tablets of AG- 013736 polymorph Form IV under fed conditions. [ 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 polymorph Forms XLI and IV in healthy volunteer [ Time Frame: 3 days per period ] [ Designated as safety issue: Yes ]

Enrollment: 42
Study Start Date: January 2010
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sequence 1 (BABA)
Treatment A: 5-mg Form IV tablet; Treatment B: 5-mg Form XLI tablets Subjects in this sequence will participate in 4 periods in the following order: B -> A -> B -> A
Drug: AG-013736
single oral dose 5-mg tablet (Form IV for Treatment A and Form XLI for Treatment B under fed conditions)
Experimental: Sequence 2 (ABAB)
Treatment A: 5-mg Form IV tablet; Treatment B: 5-mg Form XLI tablets Subjects in this sequence will participate in 4 periods in the following order: A -> B-> A -> B
Drug: AG-013736
single oral dose 5-mg tablet (Form IV for Treatment A and Form XLI for Treatment B under fed conditions)

Detailed Description:

To establish bioequivalence between Form IV and Form XLI of AG-013736 tablets

  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)
  • Use of tobacco- or nicotine- containing products (or a positive urine cotinine test).
  • Pregnant or nursing females and 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: NCT01020136

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: NCT01020136     History of Changes
Other Study ID Numbers: A4061063
Study First Received: November 23, 2009
Last Updated: April 21, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Bioequivalence Pharmacokinetics

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

ClinicalTrials.gov processed this record on September 18, 2014