Skip to main content
OpenTrials
Completed

NCT Number: NCT00543790

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Uterine Leiomyomata (Fibroids) Connective Tissue Diseases Leiomyoma Myofibroma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site, Beverly Hills, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PRA-027

Drug

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

Primary outcomes

  1. 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

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

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Oct 15, 2007
Registry last updated
Oct 28, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.