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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 midazolam

Vital 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

Page last updated: August 23, 2015

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