Study Evaluating the Pharmacokinetics of the Potential Drug Interaction Between CYP2C9 Inhibitor and Substrate
Information source: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy Subjects
Intervention: pharmacokinetic (how the body absorbs and eliminates) interaction (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Wyeth is now a wholly owned subsidiary of Pfizer Official(s) and/or principal investigator(s): Medical Monitor, Study Director, Affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
Summary
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.
Clinical Details
Official title: A Randomized, Open Label, 2-Period Crossover Study to Determine the Pharmacokinetics of the Potential Drug Interaction Between CYP2C9 Inhibitor and Substrate.
Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Both.
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.
Locations and Contacts
Additional Information
Starting date: July 2006
Last updated: August 6, 2009
|