Study Evaluating PRA-027 Multiple Ascending Doses in Cycling and Postmenopausal Women - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00543790

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 I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety Study
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:

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 ]

Estimated Enrollment:	48
Study Start Date:	November 2007
Estimated Study Completion Date:	August 2008
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	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 - 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

Contacts

Contact: Trial Manager

clintrialparticipation@wyeth.com

Locations

United States, California
	Recruiting
Beverly Hills, California, United States, 90211
United States, Florida
	Recruiting
Miami, Florida, United States, 33126

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3208A1-1001
Study First Received:	October 11, 2007
Last Updated:	December 19, 2007
ClinicalTrials.gov Identifier:	NCT00543790
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Neoplasms, Connective and Soft Tissue
Myofibroma
Connective Tissue Diseases
Leiomyoma

Additional relevant MeSH terms:

Neoplasms, Muscle Tissue
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Connective Tissue

ClinicalTrials.gov processed this record on January 15, 2009