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Sponsored by: |
Wyeth |
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Information provided by: | Wyeth |
ClinicalTrials.gov Identifier: | NCT00444704 |
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.
Condition | Intervention | Phase |
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Uterine Leiomyomata (Fibroids) |
Drug: PRA-027 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment |
Official Title: | Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PRA-027 Administered Orally to Healthy Japanese Females |
Ages Eligible for Study: | 20 Years to 64 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
INCLUSION CRITERIA
EXCLUSION CRITERIA
Contact: Trial Manager | clintrialparticipation@wyeth.com |
Japan, Ibaraki Prefecture | |
Recruiting | |
Tsukuba, Ibaraki Prefecture, Japan, 305-0856 |
Study Director: | Medical Monitor | Wyeth |
Study ID Numbers: | 3208A1-1002 |
Study First Received: | March 7, 2007 |
Last Updated: | June 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00444704 History of Changes |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Neoplasms, Connective and Soft Tissue Myofibroma Connective Tissue Diseases Healthy Leiomyoma |
Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue Neoplasms Myofibroma |
Neoplasms by Histologic Type Connective Tissue Diseases Neoplasms, Connective Tissue Leiomyoma |