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