A Midazolam Drug Interaction Study With PF-04171327

Verified by: Pfizer, December 2009
First Received: September 29, 2009 | Last Updated: December 7, 2009 | Phase: Phase 1 | Start Date: September 2009
Overall Status: Completed | Estimated Enrollment: 12
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The purpose of this study is to investigate the effects of multiple doses of PF-04171327 on the blood levels (pharmacokinetics) of...

Brief Summary

Official Title: “A Phase 1, Open Label, Multiple Dose Study Of The Effect Of PF-04171327 On Midazolam Pharmacokinetics In Healthy Volunteers”

The purpose of this study is to investigate the effects of multiple doses of PF-04171327 on the blood levels (pharmacokinetics) of midazolam

  • Study Type: Interventional
  • Study Design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: December 2009

Intervention(s) in this Clinical Trial

  • Drug: PF-04171327 25 mg
    • One 25 mg tablet administered once a day for 15 days
  • Drug: Midazolam 2 mg
    • Midazolam oral syrup 2mg dose administered once on Day 1 and once on Day 15

Arms, Groups and Cohorts in this Clinical Trial

  • Other: PF-04171327 and Midazolam

Outcome Measures for this Clinical Trial

Primary Measures

  • AUCinf of midazolam
    • Time Frame: 17 days
      Safety Issue?: No

Secondary Measures

  • AUClast, Cmax, Tmax, t1/2
    • Time Frame: 17 days
      Safety Issue?: No
  • Vital Signs, Clinical Laboratory tests and Adverse Events
    • Time Frame: 28 days
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Healthy males and/or females (non-childbearing potential) volunteers.
  • Cortisol level within normal reference range of the laboratory.

Exclusion Criteria:

  • History of intolerance or significant adverse effect with glucocorticoid (steroid) therapy.
  • History or current positive results for HIV, Hepatitis B or C or active TB or currently undergoing treatment for TB.
  • Known history of hypersensitivity, allergy severe drug reaction or unable to tolerate midazolam or other benzodiazepines.

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 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00987038

Study ID Number: A9391007

ClinicalTrials.gov Identifier: NCT00987038

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/NCT00987038