Study Evaluating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PRA-027 in Japanese Postmenopausal Women
This study has been completed.
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
First received: January 20, 2009
Last updated: March 5, 2009
Last verified: March 2009
The primary purpose of this study is to assess the safety and tolerability of ascending, multiple, oral doses of PRA-027 in Japanese postmenopausal women. The secondary purpose is to evaluate the PK and PD profile of multiple oral doses of PRA-027 in Japanese postmenopausal women.
Uterine Leiomyomata (Fibroids)
||Observational Model: Cohort
Time Perspective: Prospective
||A Randomized, Placebo-Controlled, Double-Blind, Multiple-Dose Study of the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of PRA-027 Administered Orally to Japanese Postmenopausal Women
Primary Outcome Measures:
- To assess the safety and tolerability of multiple oral doses of PRA-027 in postmenopausal women. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
Biospecimen Retention: Samples With DNA
Secondary Outcome Measures:
- To evaluate the Pharmacokinetics and Pharmacodynamics profile of multiple oral doses of PRA-027 in postmenopausal women. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||March 2009 (Final data collection date for primary outcome measure)
8 subjects for Cohort 1
8 subjects for Cohort 2
|Ages Eligible for Study:
||35 Years to 65 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Aged 35 to 65 years inclusive on study day 1 of the treatment period. Menopause may be spontaneous or due to surgery.
Postmenopausal women are defined as follows:
- Spontaneous amenorrhea must have begun by age 55 years.
- Spontaneous amenorrhea must have initiated at least 6 months before study day 1 of the treatment period.
- For subjects who have had spontaneous amenorrhea for at least 6 months but less than 12 months before screening, follicle-stimulating hormone (FSH) level must be ≥ 38 mIU/mL.
- For subjects who have had spontaneous amenorrhea for 12 months or longer before screening, no FSH level determination is required.
- For subjects who have had amenorrhea as a result of bilateral oophorectomy without hysterectomy; surgery must have occurred at least 6 months before screening. No FSH measurement is required. Subjects must provide evidence of the procedure by an operative report or by ultrasound scan. The date (month/year) of the subjects' last menstrual period must be determined and recorded on the source document.
Body mass index (BMI) in the range of 17.6 to 26.4 kg/m2 and bodyweight ≥ 45 kg.
BMI is calculated by taking the subject's weight, in kilograms, divided by the square of the subject's average height, in meters, at screening:BMI = weight (kg)/[Height (m)]2
- Healthy, as determined by the investigator, on the basis of screening evaluations.
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and creatinine levels should be below the upper limit of normal at screening.
- Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to abstain from smoking during the inpatient stay.
- Have a high probability for compliance with and completion of the study.
- Presence or history of any disorder that may prevent the successful completion of the study.
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.
- Women who have undergone a hysterectomy.
- Women with complex or simple ovarian cysts greater than 3 cm indiameter.
- 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).
- Acute disease state (eg, nausea, vomiting, fever, or diarrhea) within 7 days before receiving test article (treatment period study day 1).
- History of drug abuse.
- Admitted alcohol abuse or history of alcohol use that may interfere with the subject's ability to comply with the protocol requirements.
- History or presence of polycystic ovarian disease.
- History of female infertility.
- History or family history of arterial or venous thrombosis.
- Any clinically significant deviation from normal limits in results of physical examinations, vital sign measurements, 12-lead electrocardiograms (ECGs), or clinical laboratory tests.
- 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.
- Positive serologic findings for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies.
- Positive findings from urine drug screening (eg, amphetamines,barbiturates, benzodiazepines, cannabinoids, cocaine, opiates and phencyclidine [PCP]).
- 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)
- 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.
- 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).
- Consumption of grapefruit or grapefruit-containing products within 72 hours before study day 1 (treatment period day 1).
- 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).
- Donation of blood within 90 days before study day 1.
- Subjects deemed by the investigator to be inappropriate according for the inclusion in the study.
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For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00826436
|Kagoshima, Japan, 890-0081 |
Wyeth is now a wholly owned subsidiary of Pfizer
||Wyeth is now a wholly owned subsidiary of Pfizer
No publications provided
ClinicalTrials.gov processed this record on February 27, 2015
||Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 20, 2009
||March 5, 2009
||Japan: Ministry of Health, Labor and Welfare