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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00543790

Enrollment

Registered

2007-10-15

Start date

2007-11-30

Completion date

2008-12-31

Last updated

2010-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uterine Leiomyomata (Fibroids)

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.

Interventions

DRUGPRA-027

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

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026