Study Evaluating PRA-027 Multiple Ascending Doses In Cycling And Postmenopausal Women
Status and phase
Conditions
Treatments
Details and patient eligibility
About
This is the first multiple-dose study in humans with PRA-027. This study will provide an assessment of the safety, tolerability, pharmacokinetics (how the drug is absorbed, metabolized and excreted by the body) and pharmacodynamics (a measure of whether the drug is active in the body) of PRA-027 after administration of 28 days of oral doses in women of childbearing potential (cycling) or postmenopausal women.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Inclusion Criteria - All Women
- Healthy, nonsmoker or smoker of fewer than 10 cigarettes (half a pack) per day and able to abstain from tobacco throughout all times when in the clinical facility.
Inclusion Criteria - Cycling Women
- Aged 18 to 45 years, must not be breastfeeding, pregnant, or have a recent (within 90 days before pretreatment period day 1) history of pregnancy, with a history of regular menstrual cycles (21 to 35 days in duration).
Inclusion Criteria - Postmenopausal Women
- Aged 35 to 65 years, menopause may be natural or due to surgery, natural amenorrhea must have begun by age of 55 years and have initiated at least 6 months before study day 1.
Exclusion criteria
- Women with hysterectomy or complex or simple ovarian cysts greater than 3 cm in diameter.
- History of drug abuse (within 6 months) or alcoholism (within 12 months).
- History of female infertility.
Trial design
Primary purpose
Allocation
Interventional model
Masking
48 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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