Status:
COMPLETED
Study of the Safety, Tolerability, and PK of PRA-027 Administered to Women of Nonchildbearing Potential
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Fibroid
Eligibility:
FEMALE
18-60 years
Phase:
PHASE1
Brief Summary
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 t...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
End Date :
August 1 2007
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00427544
Start Date
February 1 2007
End Date
August 1 2007
Last Update
December 5 2007
Active Locations (1)
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1
Miami, Florida, United States, 33126