A Midazolam Drug Interaction Study With PF-04171327
Phase 1
Completed
- Conditions
- Healthy Volunteers
- Interventions
- Drug: PF-04171327 25 mg
- Registration Number
- NCT00987038
- Lead Sponsor
- Pfizer
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description PF-04171327 and Midazolam Midazolam 2 mg - PF-04171327 and Midazolam PF-04171327 25 mg -
- Primary Outcome Measures
Name Time Method AUCinf of midazolam 17 days
- Secondary Outcome Measures
Name Time Method AUClast, Cmax, Tmax, t1/2 17 days Vital Signs, Clinical Laboratory tests and Adverse Events 28 days
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸New Haven, Connecticut, United States