A Midazolam Drug Interaction Study With PF-04171327

Pfizer12 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

PF-04171327 25 mgDRUG

One 25 mg tablet administered once a day for 15 days

Midazolam 2 mgDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Pfizer Investigational Site

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

AUCinf of midazolam

Time frame: 17 days

Secondary Outcomes

AUClast, Cmax, Tmax, t1/2

Time frame: 17 days

Vital Signs, Clinical Laboratory tests and Adverse Events

Time frame: 28 days

Data from ClinicalTrials.gov

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