Study Evaluating PRA-027 Multiple Ascending Doses In Cycling And Postmenopausal Women

Phase 1

Completed

• Conditions: Uterine Leiomyomata (Fibroids)
• Interventions: Drug: PRA-027

• Registration Number: NCT00543790
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-10-11
• Study First Submitted QC: 2007-10-11
• Study First Posted: 2007-10-15
• Study Start: 2007-11
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2010-10
• Last Update Submitted: 2010-10-27
• Last Update Posted: 2010-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	PRA-027	-

Primary Outcome Measures

Name	Time	Method
To assess the safety and tolerability of ascending, multiple, oral doses of PRA-027 in cycling and postmenopausal women.	28 days

Secondary Outcome Measures

Name	Time	Method
To provide the PK and PD profile of multiple oral doses of PRA-027 in cycling and postmenopausal women.	28 days

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Miami, Florida, United States