Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PRA-027 Administered to Healthy Japanese Females

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00444704
First received: March 7, 2007
Last updated: July 8, 2009
Last verified: July 2009
  Purpose

The primary purpose of this study is to assess the safety and tolerability of ascending single oral doses of PRA-027 in healthy Japanese females. The secondary purpose is to provide the initial pharmacokinetic and pharmacodynamic profiles of PRA-027 in healthy Japanese female subjects.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PRA-027 Administered Orally to Healthy Japanese Females

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

Primary Outcome Measures:
  • The primary outcome of this study is to asess the safety and tolerability of ascending single oral doses of PRA-027 in healthy Japanese females.

Study Start Date: March 2007
Study Completion Date: December 2007
  Eligibility

Ages Eligible for Study:   20 Years to 64 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

INCLUSION CRITERIA

  1. Women of nonchildbearing potential aged 20 to 64 years. Must have a negative pregnancy test result within 48 hours before administration of test article. Women who are surgically sterile must provide documentation of the procedure by an operative report or by ultrasound scan.
  2. Body mass index (BMI) in the range of 17.6 to 26.4 kg/m2 and body weight must be at least 45 kg.
  3. Healthy as determined by the investigator on the basis of screening evaluation.

EXCLUSION CRITERIA

  1. Any significant cardiovascular, hepatic, renal, respiratory, gynecologic gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
  2. Any history of drug abuse or admitted alcohol abuse or history of alcohol use that may interfere with the subject's ability to comply with the protocol requirements.
  3. Use of any investigational drug within 90 days before study day 1, use of any prescription drug within 30 days before study day 1, consumption of any caffeine-containing products (eg, coffee, tea, chocolate, or cola) or alcoholic beverages within 48 hours before study day 1, consumption of grapefruit or grapefruit-containing products within 72 hours before study day 1, use of any over-the-counter drugs, including herbal supplements (except for the occasional use of vitamins ≤100% of the recommended daily allowance), within 14 days before study day 1, or the donation of blood within 90 days before study day 1.
  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: NCT00444704

Locations
Japan
Tsukuba, Ibaraki Prefecture, Japan, 305-0856
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00444704     History of Changes
Other Study ID Numbers: 3208A1-1002
Study First Received: March 7, 2007
Last Updated: July 8, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare

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