A Midazolam Drug Interaction Study With PF-04171327

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00987038
First received: September 29, 2009
Last updated: December 7, 2009
Last verified: December 2009
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • AUClast, Cmax, Tmax, t1/2 [ Time Frame: 17 days ] [ Designated as safety issue: No ]
  • Vital Signs, Clinical Laboratory tests and Adverse Events [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00987038     History of Changes
Other Study ID Numbers: A9391007
Study First Received: September 29, 2009
Last Updated: December 7, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
drug interaction CYP3A4 glucocorticoids midazolam

Additional relevant MeSH terms:
Midazolam
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
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

ClinicalTrials.gov processed this record on September 22, 2014