NCT00812825 - A Phase 1 Multiple-Dose Escalation and Single Dose (Tablet) Study of PF-04171327 in Healthy Volunteers | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

January 31, 2009

Primary Completion Date

July 31, 2009

Study Completion Date

July 31, 2009

Conditions

Healthy Volunteers

Interventions

DRUG

PF-04171327

PF-0417327 will be provided as an oral solution administered at doses of 1, 3, 10 and 30 mg. If an additional cohort is required, the dose selected will not exceed 100 mg. Solution will be administered once daily for 14 days.

DRUG

Prednisolone

Oral doses of prednisolone (5, 10, and 20 mg) will be administered to the first three cohorts. The fourth cohort will receive between 1 and 20 mg to be determined after the third cohort completes dosing. If an additional cohort is required, the dose selected will not exceed 40 mg. Prednisolone tablets will be administered once daily for 14 days

DRUG

Placebo

Tablets similar in appearance to prednisolone will be administered once daily for 14 days.

DRUG

Placebo Solution

Placebo solution will be administered to those volunteers who are randomized to the placebo or prednisolone arms. This will be administered orally each day for 14 days.

DRUG

PF-04171327 Tablet

A single 10 mg dose of PF-04171327 tablet formulation will be administered orally to volunteers in Part 2 of this study.

Trial Locations (1)

1070

Pfizer Investigational Site, Brussels