Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PF-05175157 · 7 trials · 6 indications
Single Dose
Single Dose
Single Dose
Steady State
Amount of PF-05175157 recovered in urine over 24 hours
Global longitudinal left ventricular strain was defined as the percent change in left ventricular longitudinal dimension in comparison to its original dimension. Global longitudinal LV strain was assessed by echocardiography using speckled tracking analysis.
Global longitudinal left ventricular strain was defined as the percent change in left ventricular longitudinal dimension in comparison to its original dimension. Global longitudinal LV strain was assessed by echocardiography using speckled tracking analysis.
Global longitudinal left ventricular strain was defined as the percent change in left ventricular longitudinal dimension in comparison to its original dimension. Global longitudinal LV strain was assessed by echocardiography using speckled tracking analysis.
OUES was defined as an index of cardiopulmonary functional reserve that was based upon a submaximal exercise effort. OUES relates oxygen uptake to total ventilation during exercise.
| Arm | Type | Description |
|---|---|---|
| PF-05175157, Midazolam | EXPERIMENTAL | Day 0: Midazolam 2 mg administered alone Days 1-14: 200 mg PF-05175157 administered BID Day 11: Midazolam and PF-05175157 |
| Placebo, Midazolam | EXPERIMENTAL | Day 0: Midazolam 2 mg administered alone Days 1-14: Placebo administered BID Day 11: Midazolam and Placebo |
| PF-05175157 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| PF-05175157 PIC in fed state | EXPERIMENTAL | 200 mg single dose of PF-05175157 administered as PIC in the fed state (following a standard high fat meal). |
| PF-05175157 tablet in fed state | EXPERIMENTAL | 200 mg single dose of PF-05175157 administered as tablet formulation in the fed state (following a standard high fat meal). |
| PF-05175157 tablet in fed state (repeat) | EXPERIMENTAL | 200 mg single dose of PF-05175157 administered as tablet formulation in the fed state (following a standard high fat meal). |
| PF-05175157 tablet in fasted state | EXPERIMENTAL | 200 mg single dose of PF-05175157 administered as tablet formulation in the fasted state (following at least a 10 hour fast). |
| Arm Label Pf-05175157, placebo, midazolam | EXPERIMENTAL | - |
| 100 mg PF-05175157 | EXPERIMENTAL | The chance of receiving 100 mg, 250 mg, 600 mg or placebo will be randomized. |
| 250 mg PF-05175157 | EXPERIMENTAL | The chance of receiving 100 mg, 250 mg, 600 mg or placebo will be randomized. |
| 600 mg PF-05175157 | EXPERIMENTAL | The chance of receiving 100 mg, 250 mg, 600 mg or placebo will be randomized. |
| Single arm, fixed sequence dosing | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| PF-05175157 | DRUG | 200 mg tablet administered twice per day for 14 days |
| Midazolam | DRUG | 2mg administered as single doses on Days 0 and 11 |
| Placebo | OTHER | Placebo administered twice per day for 14 days |
| Simvastatin | DRUG | Day 1: Single dose of simvastatin 20 mg Day 8: single dose of simvastatin 20 mg (with PF-05175157) |
Inclusion Criteria: Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study: * Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed med...
PF-05175157 is an investigational small molecule being studied for metabolic conditions, including Type 2 Diabetes Mellitus. It has been evaluated in healthy volunteers and in overweight and obese subjects with Type 2 Diabetes Mellitus. The drug is in Phase 1 clinical development and is not approved by the FDA.
PF-05175157 is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. Pfizer has sponsored multiple Phase 1 clinical trials of this investigational small molecule for metabolic indications.
PF-05175157 is in Phase 1 clinical development. All four completed trials listed on ClinicalTrials.gov are Phase 1 studies. The drug is investigational and has not been approved by the FDA for any use. It is no longer in active trials, as all its Phase 1 studies have been completed.
PF-05175157 has been studied in four completed Phase 1 trials: NCT01433380 in healthy volunteers, NCT01807377 in overweight and obese subjects with Type 2 Diabetes Mellitus, NCT01819922 in healthy subjects, and NCT01821079 in healthy volunteers. These trials assessed safety, tolerability, pharmacokinetics, and drug interactions.
PF-05175157 is the only name provided for this investigational drug. It is not known by any alternative names in the available data. The drug is a small molecule being developed by Pfizer for metabolic conditions such as Type 2 Diabetes Mellitus.