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CP-690,550 + midazolam; midazolam

Phase 1

Healthy Volunteer | Small molecule | Other |Pfizer, Inc.|Last Updated: Aug 13, 2009

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
RandomizedCONTROLLED
Total Trials1
Total Enrollment25
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00902460CP-690,550 and Midazolam Drug-Drug Interaction StudyPHASE1 COMPLETED 25Jun 1, 2009Jul 1, 2009Aug 13, 20091 United States
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Study Endpoints
Primary Endpoints
AUCinf of midazolam
10 Days
Secondary Endpoints
AUClast, Cmax, Tmax, t1/2 of midazolam
10 Days
Vital signs, laboratory tests and adverse events
10 Days
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Treatment Sequence 1EXPERIMENTAL -
Treatment Sequence 2EXPERIMENTAL -
Interventions
NameTypeDescription
midazolam; CP-690,550 + midazolamDRUGPeriod 1 : 2 mg midazolam oral syrup alone Period 2: 2 mg midazolam oral syrup plus 30 mg CP-690,550 after 6 days of CP-690,550 at 30 mg BID
CP-690,550 + midazolam; midazolamDRUGPeriod 1: 2 mg midazolam oral syrup plus 30 mg CP-690,550 after 6 days of CP-690,550 at 30 mg BID Period 2: 2 mg midazolam oral syrup alone
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and/or female (non-child bearing potential) subjects Exclusion Criteria: * Clinically significant infections within the past 3 months * History of previously untreated infection with Mycobacterium tuberculosis * Positive screening test for hepatitis B surface an...

Countries:United States
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