NCT00987038

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1 healthy-volunteers

Timeline
Completed

Started Sep 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

September 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 30, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

December 8, 2009

Status Verified

December 1, 2009

Enrollment Period

3 months

First QC Date

September 29, 2009

Last Update Submit

December 7, 2009

Conditions

Healthy Volunteers

Keywords

drug interaction CYP3A4 glucocorticoids midazolam

Outcome Measures

Primary Outcomes (1)

  • AUCinf of midazolam

    17 days

Secondary Outcomes (2)

  • AUClast, Cmax, Tmax, t1/2

    17 days

  • Vital Signs, Clinical Laboratory tests and Adverse Events

    28 days

Study Arms (1)

PF-04171327 and Midazolam

OTHER
Drug: PF-04171327 25 mgDrug: Midazolam 2 mg

Interventions

PF-04171327 25 mgDRUG

One 25 mg tablet administered once a day for 15 days

PF-04171327 and Midazolam
Midazolam 2 mgDRUG

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

PF-04171327 and Midazolam

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy males and/or females (non-childbearing potential) volunteers.
  • Cortisol level within normal reference range of the laboratory.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

Location

Related Publications (1)

  • 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.

    PMID: 29112329DERIVED

Related Links

MeSH Terms

Interventions

fosdagrocoratMidazolam

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 29, 2009

First Posted

September 30, 2009

Study Start

September 1, 2009

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

December 8, 2009

Record last verified: 2009-12

Locations

US(1)