Healthy
Conditions
Brief summary
This study will test the potential for PF-05089771 to interact with a cocktail of drugs
Interventions
DRUGPravastatin, midazolam, losartan, omeprazole, caffeine and PF-05089771
PF-05089771 450mg single dose and titration from 150mg BID to 450mg BID Pravastatin 10mg dingle dose, Midazolam 7.5mg single dose, Losartan 25mg single dose, Caffeine 100mg single dose, Omeprazole 20mg single dose
Sponsors
Pfizer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | 24h | — |
| 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) |
| Minimum Observed Plasma Trough Concentration (Cmin) | 24h | — |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | 24h | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Lipid Parameters | 14 days | Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations. |
Countries
Belgium
Outcome results
None listed