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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: midazolam; CP-690,550 + midazolam; Drug: CP-690,550 + midazolam; midazolam

Study type: Interventional

Funder types: Industry

Identifiers

NCT00902460

A3921059

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

Treatment Sequence 1

Experimental group

Treatment:

Drug: midazolam; CP-690,550 + midazolam

Treatment Sequence 2

Experimental group

Treatment:

Drug: CP-690,550 + midazolam; midazolam