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

Wyeth is now a wholly owned subsidiary of Pfizer48 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Uterine Leiomyomata (Fibroids)

Interventions

PRA-027DRUG

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

Pfizer Investigational Site

Beverly Hills, California, United States

Pfizer Investigational Site

Miami, Florida, United States

Outcomes

Primary Outcomes

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

Time frame: 28 days

Secondary Outcomes

To provide the PK and PD profile of multiple oral doses of PRA-027 in cycling and postmenopausal women.

Time frame: 28 days

Data from ClinicalTrials.gov

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