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

• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00444704
• Collaborator: (none)
• Location: 1
• Duration (Months): 9

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Uterine Leiomyomata (Fibroids)	Drug: PRA-027	Phase 1

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• 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
• Study Start Date: Mar 1, 2007
• Actual Study Completion Date: Dec 1, 2007

Outcome Measures

Primary Outcome Measures

1. 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. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 64 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1		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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00444704
• Other Study ID Numbers: 3208A1-1002
• First Posted: Mar 8, 2007
• Last Update Posted: Jul 10, 2009
• Last Verified: Jul 1, 2009

• Additional relevant MeSH terms: Leiomyoma; Myofibroma

Study Results

No Results Posted as of Jul 10, 2009