Study of the Safety, Tolerability, and PK of PRA-027 Administered to Women of Nonchildbearing Potential

Phase 1

Completed

• Conditions: Fibroid

• Registration Number: NCT00427544
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

The primary purpose of this study is to asess the safety and tolerability of ascending single oral doses of PRA-027 in healthy women of nonchildbearing potential. The secondary purpose is to provide the initial pharmacokinetic (PK) and pharmacodynamic (PD) profile of PRA-027 in healthy women of nonchildbearing potential, and to evaluate the effect of a high-fat meal on the PK and PD of PRA-027 administered to healthy women of nonchildbearing potential.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-01-25
• Study First Submitted QC: 2007-01-26
• Study First Posted: 2007-01-29
• Study Start: 2007-02
• Study Completion: 2007-08
• Status Verified: 2007-12
• Last Update Submitted: 2007-12-03
• Last Update Posted: 2007-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The primary outcome of this study is to asess the safety and tolerability of ascending single oral doses of PRA-027 in healthy women of nonchildbearing potential.