A Midazolam Drug Interaction Study With PF-04171327 | NCT00987038

Studies
A Midazolam Drug Interaction Study With PF-04171327

NCT00987038

Sponsor

Pfizer

Status

Completed

Last Update Posted

Dec 8, 2009Estimated

Enrollment

12Actual

Phase

Phase 1

Conditions

Healthy Volunteers

Interventions

PF-04171327 25 mg
Midazolam 2 mg

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2009

Primary Completion Date

Dec 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

Sep 29, 2009

First Submission Date that Met QC Criteria

Sep 29, 2009

First Posted Date

Sep 30, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 7, 2009

Last Update Posted Date

Dec 8, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PF-04171327 and Midazolam	Other		Drug: PF-04171327 25 mg Drug: Midazolam 2 mg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PF-04171327 25 mg	Drug	One 25 mg tablet administered once a day for 15 days	PF-04171327 and Midazolam

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
AUCinf of midazolam		17 days

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		New Haven	Connecticut	06511	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29112329	Derived	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.

ID	Term
C000615597	fosdagrocorat
D008874	Midazolam

ID	Term
D001569	Benzodiazepines
D001552	Benzazepines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring