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A Midazolam Drug Interaction Study With PF-04171327

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00987038
First Posted: September 30, 2009
Last Update Posted: December 8, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
  Purpose
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

  Eligibility

Information from the National Library of Medicine

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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00987038


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

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00987038     History of Changes
Other Study ID Numbers: A9391007
First Submitted: September 29, 2009
First Posted: September 30, 2009
Last Update Posted: December 8, 2009
Last Verified: December 2009

Keywords provided by Pfizer:
drug interaction CYP3A4 glucocorticoids midazolam

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