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

Last updated on February 22, 2019

FOR MORE INFORMATION
Study Location
Kagoshima, , 890-0081 Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Uterine Leiomyomata (Fibroids)
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
35-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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1. 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.

2. 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

3. Healthy, as determined by the investigator, on the basis of screening evaluations.

4. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and creatinine
levels should be below the upper limit of normal at screening.

5. 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.

6. Have a high probability for compliance with and completion of the study.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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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.

NCT00826436
Pfizer
Completed
Study Evaluating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PRA-027 in Japanese Postmenopausal Women

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