Drug-Drug Interaction Study With PF-05089771
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT01934569
- Lead Sponsor
- Pfizer
- Brief Summary
This study will test the potential for PF-05089771 to interact with a cocktail of drugs
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 17
Inclusion Criteria
- Healthy male and/or female subjects between the ages of 18 and 55 years;
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs);
Exclusion Criteria
- Any condition possibly affecting drug absorption
- History of regular alcohol consumption
- Screening supine blood pressure >140 mm Hg (systolic) or >90 mm Hg (diastolic),
- Consumption of coffee, cola or other caffeine containing drinks
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Active tratment Pravastatin, midazolam, losartan, omeprazole, caffeine and PF-05089771 Pravastatin, midazolam, losartan, omeprazole, caffeine single dose alone or in combination with PF-05089771
- Primary Outcome Measures
Name Time Method Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) 24h Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Time to Reach Maximum Observed Plasma Concentration (Tmax) 24h Maximum Observed Plasma Concentration (Cmax) 24h Minimum Observed Plasma Trough Concentration (Cmin) 24h
- Secondary Outcome Measures
Name Time Method Change from Baseline in Lipid Parameters 14 days Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations.
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇧🇪Brussels, Belgium