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Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PRA-027 Administered Orally to Healthy Japanese Females


Phase 1
20 Years
64 Years
Not Enrolling
Female
Uterine Leiomyomata (Fibroids)

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Trial Information

Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PRA-027 Administered Orally to Healthy Japanese Females

Inclusion 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

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.

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Wyeth is now a wholly owned subsidiary of Pfizer

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

3208A1-1002

NCT ID:

NCT00444704

Start Date:

March 2007

Completion Date:

December 2007

Related Keywords:

  • Uterine Leiomyomata (Fibroids)
  • Leiomyoma
  • Myofibroma

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