Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Pravastatin, midazolam, losartan, omeprazole, caffeine and PF-05089771 · 1 trial · 1 indication
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
| Arm | Type | Description |
|---|---|---|
| Active tratment | EXPERIMENTAL | Pravastatin, midazolam, losartan, omeprazole, caffeine single dose alone or in combination with PF-05089771 |
| Name | Type | Description |
|---|---|---|
| Pravastatin, midazolam, losartan, omeprazole, caffeine and PF-05089771 | DRUG | 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 |
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 ...
This is a cocktail of six small-molecule drugs studied together in healthy volunteers. Pravastatin, midazolam, losartan, omeprazole and caffeine are used as probe substrates to assess drug-drug interactions, while PF-05089771 is the investigational agent being tested for its effect on them.
PF-05089771 is a small-molecule inhibitor, and the cocktail includes pravastatin, whose molecular target is HMGCR (HMG-CoA reductase). The study was designed to evaluate how PF-05089771 affects the pharmacokinetics of the probe drugs, including pravastatin, midazolam, losartan, omeprazole and caffeine.
PF-05089771 is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer sponsored the drug-drug interaction study of PF-05089771 with pravastatin, midazolam, losartan, omeprazole and caffeine in healthy volunteers.
The study is a Phase 1 trial. It has been completed, and no active trials of this combination are ongoing. The trial enrolled 17 healthy volunteers and was conducted in Belgium. PF-05089771 remains an investigational agent and is not approved for any indication based on this program.
PF-05089771 was evaluated in the completed Phase 1 trial NCT01934569, titled Drug-Drug Interaction Study With PF-05089771. The trial enrolled 17 healthy adult volunteers of all sexes, aged 18 years and older, in Belgium. It was an uncontrolled study without randomization or double blinding.