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

Verified by: Pfizer, August 2009
First Received: May 14, 2009 | Last Updated: August 12, 2009 | Phase: Phase 1 | Start Date: June 2009
Overall Status: Completed | Estimated Enrollment: 25
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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...

Brief Summary

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”

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.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: July 2009

Intervention(s) in this Clinical Trial

  • 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
  • Drug: 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

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: Treatment Sequence 1
  • Experimental: Treatment Sequence 2

Outcome Measures for this Clinical Trial

Primary Measures

  • AUCinf of midazolam
    • Time Frame: 10 Days
      Safety Issue?: No

Secondary Measures

  • AUClast, Cmax, Tmax, t1/2 of midazolam
    • Time Frame: 10 Days
      Safety Issue?: Yes
  • Vital signs, laboratory tests and adverse events
    • Time Frame: 10 Days
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 55 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Clinical Trial Investigator Information

Lead Investigator: Pfizer Industry

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00902460

Study ID Number: A3921059

ClinicalTrials.gov Identifier: NCT00902460

Health Authority: United States: Food and Drug Administration

To obtain contact information for a study center near you, click here.

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http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00902460