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

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00543790
First received: October 11, 2007
Last updated: October 27, 2010
Last verified: October 2010
  Purpose

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.


Condition Intervention Phase
Uterine Leiomyomata (Fibroids)
Drug: PRA-027
Phase 1

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

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • To assess the safety and tolerability of ascending, multiple, oral doses of PRA-027 in cycling and postmenopausal women. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To provide the PK and PD profile of multiple oral doses of PRA-027 in cycling and postmenopausal women. [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: November 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: PRA-027
PRA-027 capsules; cohort-specific doses or 40, 120, 240 or 500 mg; 1 dose daily for 28 days

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00543790

Locations
United States, California
Pfizer Investigational Site
Beverly Hills, California, United States, 90211
United States, Florida
Pfizer Investigational Site
Miami, Florida, United States, 33126
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier: NCT00543790     History of Changes
Other Study ID Numbers: 3208A1-1001, B2531001
Study First Received: October 11, 2007
Last Updated: October 27, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases

ClinicalTrials.gov processed this record on July 29, 2014