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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
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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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Frequently asked questions about midazolam; CP-690, 550+ midazolam

What is midazolam?

Midazolam is a small molecule drug studied by Pfizer in healthy adult volunteers. It appears in a Phase 1 drug-drug interaction study alongside CP-690,550, also known as tofacitinib. The trial enrolled 25 participants and has been completed. Midazolam is not described here as a treatment for a specific disease.

Who is developing midazolam in the CP-690,550 drug-drug interaction study?

Pfizer, Inc. (ticker PFE) is the developer listed for the CP-690,550 and midazolam drug-drug interaction study. The work was conducted in the United States in healthy volunteers rather than in patients with a disease indication.

What phase is the CP-690,550 and midazolam drug interaction study in?

The CP-690,550 and midazolam drug-drug interaction study is a Phase 1 trial. It has been completed, and it enrolled 25 healthy adult volunteers aged 18 years and older. The study was randomized and controlled, and it was not double blind.

What clinical trial studied midazolam with CP-690,550?

The trial is NCT00902460, titled CP-690,550 and Midazolam Drug-Drug Interaction Study. It was a Phase 1, randomized, controlled study of 25 healthy volunteers conducted in the United States. The trial is listed as completed, and no active trials of this combination are ongoing.

What is midazolam used for in healthy volunteer studies?

In this Phase 1 study, midazolam was administered to healthy adult volunteers as part of a drug-drug interaction assessment with CP-690,550. The trial enrolled 25 participants in the United States and is completed. Midazolam is not being studied here for a disease treatment.