Study Evaluating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PRA-027 in Japanese Postmenopausal Women

Exclusion Criteria

• •1. Presence or history of any disorder that may prevent the successful completion of the study.
• •2. Any significant cardiovascular, hepatic, renal, respiratory,gynecologic, gastrointestinal, endocrine, immunologic,dermatologic, hematologic, neurologic, or psychiatric disease.
• •\- Women with asymptomatic leiomyomata may be enrolled in the study.
• •3. Women who have undergone a hysterectomy.
• •4. Women with complex or simple ovarian cysts greater than 3 cm indiameter.
• •5. Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the test article (eg, resection of liver, kidney, gallbladder, or gastrointestinal tract).
• •6. Acute disease state (eg, nausea, vomiting, fever, or diarrhea) within 7 days before receiving test article (treatment period study day 1).
• •7. History of drug abuse.
• •8. Admitted alcohol abuse or history of alcohol use that may interfere with the subject's ability to comply with the protocol requirements.
• •9. History or presence of polycystic ovarian disease.
• •10. History of female infertility.
• •11. History or family history of arterial or venous thrombosis.
• •12. Any clinically significant deviation from normal limits in results of physical examinations, vital sign measurements, 12-lead electrocardiograms (ECGs), or clinical laboratory tests.
• •13. Demonstration of positive findings on orthostatic testing at screening. The definition of a positive finding is a ≥20 mm Hg decrease in systolic blood pressure, a ≥ 10 mm Hg decrease in diastolic blood pressure, or a ≥ 30 bpm increase in pulse, after standing for 3 minutes.
• •14. Positive serologic findings for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies.
• •15. Positive findings from urine drug screening (eg, amphetamines,barbiturates, benzodiazepines, cannabinoids, cocaine, opiates and phencyclidine \[PCP\]).
• •16. History of any clinically important drug allergy or adverse drug reaction (eg, relapsing dermatitis, drug hypersensitivity, drug allergy, hypersensitivity to ingredient in the test articles, angioedemas)
• •17. Use of any investigational or prescription drug within 90 days before receiving test article (treatment period day 1)or prescription drug within 30 days before study day 1.
• •18. Consumption of any caffeine-containing products (eg, coffee, tea, chocolate, or carbonated beverages) or alcoholic beverages within 48 hours before receiving test article (treatment period day 1).
• •19. Consumption of grapefruit or grapefruit-containing products within 72 hours before study day 1 (treatment period day 1).
• •20. Use of any over-the-counter drugs, including herbal supplements (except for the use of vitamins ≤ 100% of the recommended daily allowance), within 14 days before receiving test article (treatment period day 1).
• •21. Donation of blood within 90 days before study day 1.
• •22. Subjects deemed by the investigator to be inappropriate according for the inclusion in the study.