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A Midazolam Drug Interaction Study With PF-04171327

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: September 29, 2009
Last updated: December 7, 2009
Last verified: December 2009
The purpose of this study is to investigate the effects of multiple doses of PF-04171327 on the blood levels (pharmacokinetics) of midazolam

Condition Intervention Phase
Healthy Volunteers Drug: PF-04171327 25 mg Drug: Midazolam 2 mg Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open Label, Multiple Dose Study Of The Effect Of PF-04171327 On Midazolam Pharmacokinetics In Healthy Volunteers

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • AUCinf of midazolam [ Time Frame: 17 days ]

Secondary Outcome Measures:
  • AUClast, Cmax, Tmax, t1/2 [ Time Frame: 17 days ]
  • Vital Signs, Clinical Laboratory tests and Adverse Events [ Time Frame: 28 days ]

Enrollment: 12
Study Start Date: September 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
PF-04171327 and Midazolam 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


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00987038

United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00987038     History of Changes
Other Study ID Numbers: A9391007
Study First Received: September 29, 2009
Last Updated: December 7, 2009

Keywords provided by Pfizer:
drug interaction CYP3A4 glucocorticoids midazolam

Additional relevant MeSH terms:
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action processed this record on September 19, 2017