Trials / Completed
CompletedNCT00543790
Study Evaluating PRA-027 Multiple Ascending Doses In Cycling And Postmenopausal Women
A Randomized, Placebo-Controlled, Double-Blind, Sponsor-Unblinded, Multiple-Dose Study Of The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of PRA-027 Administered Orally To Cycling Or Postmenopausal Women
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer · Industry
- Sex
- Female
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
Summary
This is the first multiple-dose study in humans with PRA-027. This study will provide an assessment of the safety, tolerability, pharmacokinetics (how the drug is absorbed, metabolized and excreted by the body) and pharmacodynamics (a measure of whether the drug is active in the body) of PRA-027 after administration of 28 days of oral doses in women of childbearing potential (cycling) or postmenopausal women.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PRA-027 | PRA-027 capsules; cohort-specific doses or 40, 120, 240 or 500 mg; 1 dose daily for 28 days |
Timeline
- Start date
- 2007-11-01
- Primary completion
- 2008-12-01
- Completion
- 2008-12-01
- First posted
- 2007-10-15
- Last updated
- 2010-10-28
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00543790. Inclusion in this directory is not an endorsement.