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PRA-027

Phase 1

Uterine Leiomyomata (Fibroids) | Small molecule | Other |Pfizer, Inc.|Last Updated: Oct 28, 2010

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindUNCONTROLLEDBiomarker
Total Trials2
Total Enrollment48
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00543790Study Evaluating PRA-027 Multiple Ascending Doses In Cycling And Postmenopausal WomenPHASE1 COMPLETED 48 — — Nov 1, 2007Dec 1, 2008Oct 28, 20102 United States
NCT00444704Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PRA-027 Administered to Healthy Japanese FemalesPHASE1 COMPLETED - — — Mar 1, 2007Dec 1, 2007Jul 10, 20091 Japan
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Study Endpoints
Primary Endpoints
To assess the safety and tolerability of ascending, multiple, oral doses of PRA-027 in cycling and postmenopausal women.
28 days
The primary outcome of this study is to asess the safety and tolerability of ascending single oral doses of PRA-027 in healthy Japanese females.
Secondary Endpoints
To provide the PK and PD profile of multiple oral doses of PRA-027 in cycling and postmenopausal women.
28 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
Interventions
NameTypeDescription
PRA-027DRUGPRA-027 capsules; cohort-specific doses or 40, 120, 240 or 500 mg; 1 dose daily for 28 days
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Eligibility Criteria
Age Range18 Years — 65 Years
SexFEMALE
Healthy VolunteersYes
Study Sites2

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 breastfee...

Countries:United StatesJapan
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