CP-690,550 and Midazolam Drug-Drug Interaction Study

Pfizer25 enrolled

Overview

CP-690,550 and midazolam are metabolized by similar enzymes in the liver. This study is designed to assess whether co-administration of CP-690,500 and midazolam will effect the metabolism of midazolam in healthy volunteers.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Volunteer

Interventions

midazolam; CP-690,550 + midazolamDRUG

Period 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; midazolamDRUG

Period 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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 antigen, anti-hepatitis C antibody, or human immunodeficiency virus

Locations (1)

Pfizer Investigational Site

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

AUCinf of midazolam

Time frame: 10 Days

Secondary Outcomes

AUClast, Cmax, Tmax, t1/2 of midazolam

Time frame: 10 Days

Vital signs, laboratory tests and adverse events

Time frame: 10 Days

Data from ClinicalTrials.gov

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