Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PRA-027 Administered Orally to Healthy Women of Nonchildbearing Potential
- 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.
- Any significant cardiovascular, hepatic, renal, respiratory, gynecologic,
gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or
- 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,
- 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.