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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00987038

Enrollment

Registered

2009-09-30

Start date

2009-09-30

Completion date

2009-12-31

Last updated

2009-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

drug interaction CYP3A4 glucocorticoids midazolam

Brief summary

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

Interventions

DRUGPF-04171327 25 mg

One 25 mg tablet administered once a day for 15 days

DRUGMidazolam 2 mg

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
AUCinf of midazolam	17 days

Secondary

Measure	Time frame
AUClast, Cmax, Tmax, t1/2	17 days
Vital Signs, Clinical Laboratory tests and Adverse Events	28 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026