A Midazolam Drug Interaction Study With PF-04171327

NCT ID: NCT00987038

Last Updated: 2009-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2009-12-31

Brief Summary

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

Detailed Description

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Conditions

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Healthy Volunteers

Keywords

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drug interaction CYP3A4 glucocorticoids midazolam

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PF-04171327 and Midazolam

Group Type OTHER

PF-04171327 25 mg

Intervention Type DRUG

One 25 mg tablet administered once a day for 15 days

Midazolam 2 mg

Intervention Type DRUG

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

Interventions

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PF-04171327 25 mg

One 25 mg tablet administered once a day for 15 days

Intervention Type DRUG

Midazolam 2 mg

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

New Haven, Connecticut, United States

Site Status

Countries

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United States

References

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Ripp SL, Mukherjee A, Eng H, Stock T, Fleishaker D, Checchio T, Tammara B. In Vitro and In Vivo Investigation of Potential for Complex CYP3A Interaction for PF-00251802 (Dagrocorat), a Novel Dissociated Agonist of the Glucocorticoid Receptor. Clin Pharmacol Drug Dev. 2018 Mar;7(3):244-255. doi: 10.1002/cpdd.411. Epub 2017 Nov 7.

Reference Type DERIVED
PMID: 29112329 (View on PubMed)

Related Links

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Other Identifiers

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A9391007

Identifier Type: -

Identifier Source: org_study_id