Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PF-05175157 · 7 trials · 5 indications
Single Dose
Single Dose
Single Dose
Steady State
Amount of PF-05175157 recovered in urine over 24 hours
Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to PF-05175157 was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
| 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 |
| 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. |
| Placebo | PLACEBO_COMPARATOR | The chance of receiving 100 mg, 250 mg, 600 mg or placebo will be randomized. |
| Single arm, fixed sequence dosing | EXPERIMENTAL | - |
| 30 mg PF-05175157 or Placebo QD | EXPERIMENTAL | - |
| 100 mg PF-05175157 or Placebo QD | EXPERIMENTAL | Planned dose might be modified based on emerging safety and PK data. |
| 200 mg PF-05175157 or Placebo QD | EXPERIMENTAL | Planned dose might be modified based on emerging safety and PK data. |
| 100 mg PF-05175157 or Placebo BID | EXPERIMENTAL | Planned dose might be modified based on emerging safety and PK data. |
| xxx mg PF-05175157 | EXPERIMENTAL | Dose will be determined based on results obtained from Arms 1 to 4. |
| 10 mg PF-05175157 or Placebo | EXPERIMENTAL | Subjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order. |
| 30 mg PF-05175157 or Placebo | EXPERIMENTAL | Subjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order. |
| 100 mg PF-05175157 or Placebo | EXPERIMENTAL | Subjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order. |
| 300 mg PF-05175157 or Placebo | EXPERIMENTAL | Subjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order. |
| 600 mg PF-05175157 or Placebo | EXPERIMENTAL | Subjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order. |
| 800 mg PF-05175157 or Placebo | EXPERIMENTAL | Subjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order. |
| xxx mg PF-05175157 or Placebo | EXPERIMENTAL | Subjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order. |
| 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) |
| PF-05175157 or Placebo | DRUG | One oral dose of PF-05175157 or placebo is administered as a powder-in-capsule once daily for 14 days immediately before breakfast, in healthy volunteers. |
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 developed by Pfizer, Inc. (ticker PFE) for type 2 diabetes mellitus and diabetes mellitus. It is a Phase 1 clinical candidate in the metabolic therapeutic area and has not been approved for any indication.
PF-05175157 is being studied for the treatment of type 2 diabetes mellitus and diabetes mellitus. All clinical work to date has been Phase 1, with trials conducted in healthy overweight and obese volunteers rather than in patients with confirmed disease.
PF-05175157 targets ACACA and ACACB, also known as acetyl-CoA carboxylase alpha and beta. It acts as an inhibitor of these enzymes. Both targets belong to the acetyl-CoA carboxylase family, which is the basis for its investigation in metabolic disease.
Pfizer, Inc. is the developer of PF-05175157. The company trades under the ticker PFE and holds the compound, which carries the ChEMBL identifier CHEMBL3359265.
PF-05175157 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA or any other regulator. Six Phase 1 trials have been completed, and no trials are currently active.
Six completed Phase 1 trials have evaluated PF-05175157, including NCT01807377, NCT01757756, NCT01537497, and NCT01469468. These studies enrolled healthy overweight and obese volunteers in the United States and assessed safety, tolerability, pharmacokinetics, and drug interaction with midazolam and simvastatin.