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A Midazolam Drug Interaction Study With PF-04171327

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Volunteers
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy males and/or females (non-childbearing potential) volunteers.

- Cortisol level within normal reference range of the laboratory.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00987038
Pfizer
Completed
A Midazolam Drug Interaction Study With PF-04171327

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A Midazolam Drug Interaction Study With PF-04171327
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
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Healthy Volunteers
  • 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
PF-04171327 and Midazolam
Interventions:
  • Drug: PF-04171327 25 mg
  • Drug: Midazolam 2 mg
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
December 2009
December 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00987038
A9391007
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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