Study Evaluating PRA-027 Multiple Ascending Doses In Cycling And Postmenopausal Women
A Randomized, Placebo-Controlled, Double-Blind, Sponsor-Unblinded, Multiple-Dose Study Of The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of PRA-027 Administered Orally To Cycling Or Postmenopausal Women
2 other identifiers
interventional
48
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Nov 2007
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 11, 2007
CompletedFirst Posted
Study publicly available on registry
October 15, 2007
CompletedStudy Start
First participant enrolled
November 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedOctober 28, 2010
October 1, 2010
1.1 years
October 11, 2007
October 27, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
To assess the safety and tolerability of ascending, multiple, oral doses of PRA-027 in cycling and postmenopausal women.
28 days
Secondary Outcomes (1)
To provide the PK and PD profile of multiple oral doses of PRA-027 in cycling and postmenopausal women.
28 days
Study Arms (1)
1
EXPERIMENTALInterventions
PRA-027 capsules; cohort-specific doses or 40, 120, 240 or 500 mg; 1 dose daily for 28 days
Eligibility Criteria
You may qualify if:
- 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.
- 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).
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Pfizer Investigational Site
Beverly Hills, California, 90211, United States
Pfizer Investigational Site
Miami, Florida, 33126, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 11, 2007
First Posted
October 15, 2007
Study Start
November 1, 2007
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
October 28, 2010
Record last verified: 2010-10