CP-690,550 and Midazolam Drug-Drug Interaction Study
Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy Volunteer
Intervention: midazolam; CP-690,550 + midazolam (Drug); CP-690,550 + midazolam; midazolam (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s): Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: AUCinf of midazolam
Secondary outcome: AUClast, Cmax, Tmax, t1/2 of midazolamVital signs, laboratory tests and adverse events
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
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 and Contacts
Pfizer Investigational Site, New Haven, Connecticut 06511, United States
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: June 2009
Last updated: August 12, 2009
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