Trials / Completed

CompletedNCT00427544

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

Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PRA-027 Administered Orally to Healthy Women of Nonchildbearing Potential

Status: Completed
Phase: Phase 1
Study type: Interventional
Enrollment: —

Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer · Industry
Sex: Female
Age: 18 Years – 60 Years
Healthy volunteers: Accepted

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.

Conditions

Fibroid

Interventions

Type	Name	Description
DRUG	PRA-027

Timeline

Start date: 2007-02-01
Completion: 2007-08-01
First posted: 2007-01-29
Last updated: 2007-12-05

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00427544. Inclusion in this directory is not an endorsement.