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

Wyeth

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: pharmacokinetic (how the body absorbs and eliminates) interaction

Study type: Interventional

Funder types: Industry

Identifiers

NCT00369304

3189A1-103

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)