Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PRA-027 Administered to Healthy Japanese Females

Uterine Leiomyomata (Fibroids) Clinical Trial

Official title:
Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PRA-027 Administered Orally to Healthy Japanese Females

Status Completed

Clinical Trial Summary

The primary purpose of this study is to assess the safety and tolerability of ascending single oral doses of PRA-027 in healthy Japanese females. The secondary purpose is to provide the initial pharmacokinetic and pharmacodynamic profiles of PRA-027 in healthy Japanese female subjects.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00444704
Study type	Interventional
Source	Wyeth is now a wholly owned subsidiary of Pfizer
Contact
Status	Completed
Phase	Phase 1
Start date	March 2007
Completion date	December 2007

View Details

See also
	Status	Clinical Trial	Phase
	Completed	`NCT00826436` - Study Evaluating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PRA-027 in Japanese Postmenopausal Women	N/A
	Completed	`NCT00543790` - Study Evaluating PRA-027 Multiple Ascending Doses In Cycling And Postmenopausal Women	Phase 1