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

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: midazolam; CP-690,550 + midazolam; Drug: CP-690,550 + midazolam; midazolam

• Registration Number: NCT00902460
• Lead Sponsor: Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-05-14
• Study First Submitted QC: 2009-05-14
• Study First Posted: 2009-05-15
• Study Start: 2009-06
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Status Verified: 2009-08
• Last Update Submitted: 2009-08-12
• Last Update Posted: 2009-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment Sequence 1	midazolam; CP-690,550 + midazolam	-
Treatment Sequence 2	CP-690,550 + midazolam; midazolam	-

Primary Outcome Measures

Name	Time	Method
AUCinf of midazolam	10 Days

Secondary Outcome Measures

Name	Time	Method
AUClast, Cmax, Tmax, t1/2 of midazolam	10 Days
Vital signs, laboratory tests and adverse events	10 Days

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 New Haven, Connecticut, United States