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NCT00902460 Clinical Trial

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

Healthy Volunteer Clinical Trial

Official title:
A Phase 1, Randomized, 2-Way Crossover, Multiple Dose, Open Label Study Of The Effect Of CP-690,550 On Midazolam Pharmacokinetics In Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00902460
Other study ID # A3921059
Secondary ID
Status Completed
Phase Phase 1
First received May 14, 2009
Last updated August 12, 2009
Start date June 2009
Est. completion date July 2009

Study information
Verified date August 2009
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 25
Est. completion date July 2009
Est. primary completion date July 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 55 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Pfizer Investigational Site New Haven Connecticut

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary AUCinf of midazolam 10 Days No
Secondary AUClast, Cmax, Tmax, t1/2 of midazolam 10 Days Yes
Secondary Vital signs, laboratory tests and adverse events 10 Days Yes
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