Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PRA-027 Administered to Healthy Japanese Females
Phase 1
Completed
- Conditions
- Uterine Leiomyomata (Fibroids)
- Registration Number
- NCT00444704
- Lead Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Brief 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.
- Detailed Description
Not available
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 Japanese females.
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms of PRA-027 in treating uterine fibroids in Japanese females?
How does PRA-027 compare to standard-of-care treatments for uterine leiomyomata in terms of efficacy and safety?
Which biomarkers are associated with PRA-027's pharmacodynamic effects in healthy Japanese female subjects?
What adverse events were observed in the Phase 1 trial of PRA-027 and how were they managed?
Are there any related compounds or combination therapies being developed for uterine fibroids alongside PRA-027?