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Study Evaluating the Pharmacokinetics of the Potential Drug Interaction Between CYP2C9 Inhibitor and Substrate

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00369304
First received: August 25, 2006
Last updated: August 6, 2009
Last verified: August 2009
  Purpose

This is an open-label, randomized, 2-period crossover, inpatient study to be performed in healthy subjects. The study will consist of 2 treatment periods: There will be 2 parallel cohorts of 12 subjects each who will be enrolled to receive single doses of tolbutamide or AGG-523 plus tolbutamide in periods 1 and 2 in a crossover design. Doses of test article will be administered after an overnight fast of at least 10 hours.


Condition Intervention Phase
Healthy Subjects
Drug: pharmacokinetic (how the body absorbs and eliminates) interaction
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open Label, 2-Period Crossover Study to Determine the Pharmacokinetics of the Potential Drug Interaction Between CYP2C9 Inhibitor and Substrate.

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • To evaluate the effects of a single oral dose of AGG-523 on the pharmacokinetic profile of a single oral dose of tolbutamide in healthy subjects.

Study Start Date: July 2006
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  1. Men and women, aged 18 to 50 years. Women of non-childbearing potential may be included.
  2. Body mass index in the range of 18 to 30 kg/meter squared and body weight equal to or greater than 50 kg.
  3. Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12 lead electrocardiogram (graphic trace of the pattern of your heart beat).
  4. Non-smoker or smoker of fewer than 10 cigarettes (half a pack) per day as determined by history. Must abstain from smoking during inpatient stay.
  5. Have a high probability for compliance with and completion of the study.
  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: NCT00369304

Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00369304     History of Changes
Other Study ID Numbers: 3189A1-103
Study First Received: August 25, 2006
Last Updated: August 6, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Health

ClinicalTrials.gov processed this record on November 23, 2014