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Completed

NCT Number: NCT00987038

A Midazolam Drug Interaction Study With PF-04171327

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

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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PF-04171327 25 mg

Drug

One 25 mg tablet administered once a day for 15 days

Midazolam 2 mg

Drug

Midazolam oral syrup 2mg dose administered once on Day 1 and once on Day 15

Primary outcomes

  1. AUCinf of midazolam

    Time frame: 17 days

Secondary outcomes

  1. AUClast, Cmax, Tmax, t1/2

    Time frame: 17 days

  2. Vital Signs, Clinical Laboratory tests and Adverse Events

    Time frame: 28 days

Interested in participating?

Completed

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Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Sep 30, 2009
Registry last updated
Dec 8, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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