Fibroid Clinical Trial
Official title:
Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PRA-027 Administered Orally to Healthy Women of Nonchildbearing Potential
The primary purpose of this study is to asess the safety and tolerability of ascending single oral doses of PRA-027 in healthy women of nonchildbearing potential. The secondary purpose is to provide the initial pharmacokinetic (PK) and pharmacodynamic (PD) profile of PRA-027 in healthy women of nonchildbearing potential, and to evaluate the effect of a high-fat meal on the PK and PD of PRA-027 administered to healthy women of nonchildbearing potential.
Status | Completed |
Enrollment | 0 |
Est. completion date | August 2007 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 60 Years |
Eligibility |
INCLUSION CRITERIA - Women of nonchildbearing potential (WONCBP) aged 18 to 60 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 ultrasound scan. - Body mass index (BMI) in the range of 18.0 to 30.0 kg/m2 and body weight ³50 kg. BMI is calculated by taking the subject's weight, in kilograms, divided by the square of the subject's height, in meters, at screening: BMI=weight (kg)/[height (m)]2 - Healthy as determined by the investigator on the basis of screening evaluations. EXCLUSION CRITERIA - Any significant cardiovascular, hepatic, renal, respiratory, gynecologic, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease. - A history of drug abuse within 1 year before study day 1, a history of alcoholism within 1 year before study day 1 or consumption of more than 2 standard units of alcohol per day (a standard unit equals 12 ounces of beer, 1½ ounces of 80-proof alcohol, or 6 ounces of wine). Any positive findings during the urine drug screen for amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, and opiates. - Use of any investigational or prescription drug within 30 days before test article administration. Consumption of any caffeine-containing products (eg, coffee, tea, chocolate, or soda) 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 acetaminophen and vitamins =100% of the recommended daily allowance) within 14 days before study day 1. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Wyeth is now a wholly owned subsidiary of Pfizer |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary outcome of this study is to asess the safety and tolerability of ascending single oral doses of PRA-027 in healthy women of nonchildbearing potential. |
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