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Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PRA-027 Administered to Healthy Japanese Females

Last updated on March 14, 2019

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Study Location
Tsukuba, Ibaraki Prefecture, 305-0856 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
20-64 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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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.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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1. Any significant cardiovascular, hepatic, renal, respiratory, gynecologic
gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or
psychiatric disease.

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.

NCT00444704
Pfizer
Completed
Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PRA-027 Administered to Healthy Japanese Females

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