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

Uterine Leiomyomata (Fibroids) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00543790
• Other study ID #: 3208A1-1001
• Secondary ID: B2531001
• Status: Completed
• Phase: Phase 1
• First received: October 11, 2007
• Last updated: October 27, 2010
• Start date: November 2007
• Est. completion date: December 2008

Study information

• Verified date: October 2010
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Leiomyomata (Fibroids)

Intervention

Drug:
• PRA-027
PRA-027 capsules; cohort-specific doses or 40, 120, 240 or 500 mg; 1 dose daily for 28 days

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Beverly Hills	California
United States	Pfizer Investigational Site	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the safety and tolerability of ascending, multiple, oral doses of PRA-027 in cycling and postmenopausal women.		28 days	Yes
Secondary	To provide the PK and PD profile of multiple oral doses of PRA-027 in cycling and postmenopausal women.		28 days	No

External Links

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