Study Results
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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COMPLETED
PHASE1
12 participants
INTERVENTIONAL
2009-09-30
2009-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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PF-04171327 and Midazolam
PF-04171327 25 mg
One 25 mg tablet administered once a day for 15 days
Midazolam 2 mg
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
Midazolam 2 mg
Midazolam oral syrup 2mg dose administered once on Day 1 and once on Day 15
Eligibility Criteria
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Inclusion Criteria
* Cortisol level within normal reference range of the laboratory.
Exclusion Criteria
* 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.
18 Years
55 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
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
Countries
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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.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A9391007
Identifier Type: -
Identifier Source: org_study_id