Study Evaluating PRA-027 Multiple Ascending Doses In Cycling And Postmenopausal Women
This study has been completed.
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00543790
First received: October 11, 2007
Last updated: October 27, 2010
Last verified: October 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Uterine Leiomyomata (Fibroids) |
Drug: PRA-027 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | 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 |
Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Primary Outcome Measures:
- To assess the safety and tolerability of ascending, multiple, oral doses of PRA-027 in cycling and postmenopausal women. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To provide the PK and PD profile of multiple oral doses of PRA-027 in cycling and postmenopausal women. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
| Enrollment: | 48 |
| Study Start Date: | November 2007 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: PRA-027
PRA-027 capsules; cohort-specific doses or 40, 120, 240 or 500 mg; 1 dose daily for 28 days
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
Inclusion Criteria - All Women
- Healthy, nonsmoker or smoker of fewer than 10 cigarettes (half a pack) per day and able to abstain from tobacco throughout all times when in the clinical facility.
Inclusion Criteria - Cycling Women
- Aged 18 to 45 years, must not be breastfeeding, pregnant, or have a recent (within 90 days before pretreatment period day 1) history of pregnancy, with a history of regular menstrual cycles (21 to 35 days in duration).
Inclusion Criteria - Postmenopausal Women
- Aged 35 to 65 years, menopause may be natural or due to surgery, natural amenorrhea must have begun by age of 55 years and have initiated at least 6 months before study day 1.
Exclusion Criteria:
- Women with hysterectomy or complex or simple ovarian cysts greater than 3 cm in diameter.
- History of drug abuse (within 6 months) or alcoholism (within 12 months).
- History of female infertility.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00543790
Locations
| United States, California | |
| Pfizer Investigational Site | |
| Beverly Hills, California, United States, 90211 | |
| United States, Florida | |
| Pfizer Investigational Site | |
| Miami, Florida, United States, 33126 | |
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc |
| ClinicalTrials.gov Identifier: | NCT00543790 History of Changes |
| Other Study ID Numbers: | 3208A1-1001, B2531001 |
| Study First Received: | October 11, 2007 |
| Last Updated: | October 27, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Leiomyoma Myofibroma Neoplasms, Muscle Tissue Neoplasms, Connective and Soft Tissue |
Neoplasms by Histologic Type Neoplasms Neoplasms, Connective Tissue Connective Tissue Diseases |
ClinicalTrials.gov processed this record on May 19, 2013