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midazolam; CP-690, 550+ midazolam

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment25

FDA Designations

No designations recorded

Clinical trial landscape

midazolam; CP-690, 550+ midazolam · 1 trial · 1 indication

Phase 1 1
NCT00902460CP-690,550 and Midazolam Drug-Drug Interaction StudyHealthy Volunteer
COMPLETED25 Analytics
PHASE1COMPLETED
CP-690,550 and Midazolam Drug-Drug Interaction Study
Healthy Volunteer
NCT0090246025
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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 to 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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