Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PF-04937319 high dose · 1 trial · 1 indication
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 14 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.
A hypoglycemic event (HAE) was identified by characteristic symptoms or blood glucose levels. HAE was defined as 1 of the given definitions: 1) Characteristic symptoms of HAE with no home glucose monitoring performed where clinical picture included prompt resolution with food intake, subcutaneous glucagon, or intravenous glucose; 2) Characteristic symptoms of HAE with home glucose monitoring measurement of less than or equal to (=\<) 70 milligram per deciliter (mg/dL) using sponsor-provided, plasma-referenced, home glucometers (or central laboratory); 3) any glucose value =\<49 mg/dL using sponsor-provided, plasma-referenced, home glucometers (or central laboratory) with or without accompanying symptoms.
AUC24 is the area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose (0 to 24).
AUC24 is the area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose (0 to 24).
Ctrough is the concentration prior to study drug administration.
Cav is the average plasma concentration during the 0 to 24 hour time period.
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the oral bioavailability. It is calculated as the total oral daily dose divided by AUC24, where AUC24 is the area under the plasma concentration-time profile from time 0 to 24 hours.
Terminal half-life is the time measured for the plasma concentration to decrease by one half. Terminal half-life is calculated by dividing the natural logarithm to the base e (Log e) multiplied by (\*) 2/k el, where 'k el' is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose is influenced by the oral bioavailability. It is calculated as the total oral daily dose divided by AUC24\* k el, where AUC24 is the area under the plasma concentration-time profile from time 0 to 24 hours and terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Rac is based on AUC24. It is the ratio of AUC24 of Day 7 and AUC24 of Day 1, where AUC24 is the area under the plasma concentration-time profile from time 0 to 24 hours.
| Arm | Type | Description |
|---|---|---|
| PF-04937319 | EXPERIMENTAL | PF-04937319 Split dose |
| Placebo | PLACEBO_COMPARATOR | Placebo split dose |
| Name | Type | Description |
|---|---|---|
| PF-04937319 high dose | DRUG | tablets, 150 mg with breakfast plus 100 mg with lunch, 7 days |
| PF-04937319 low dose | DRUG | tablets, 50 mg with breakfast plus 50 mg with lunch, 7 days |
| Placebo | DRUG | tablets, breakfast plus lunch, 7 days |
Inclusion Criteria: * Patients with type 2 diabetes, on diet/exercise therapy only or background therapy with 1 oral anti-diabetic agent (excluding Actos) Exclusion Criteria: * Patients with cardiovascular event * Patients with diabetic complications * Female subjects who are pregnant or planning...
PF-04937319 high dose is an investigational small molecule being studied for Type 2 Diabetes Mellitus, Dermatomyositis, and Non-alcoholic Fatty Liver Disease (NAFLD). It is developed by Pfizer, Inc. and is in clinical development, with trials completed in these indications.
PF-04937319 high dose is developed by Pfizer, Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker PFE. The drug is an investigational small molecule in clinical development for metabolic and other conditions.
PF-04937319 high dose is in Phase 1 clinical development. It has completed one Phase 1 trial in Type 2 Diabetes Mellitus, along with Phase 2 trials in Dermatomyositis and Non-alcoholic Fatty Liver Disease. The drug is investigational and not yet approved.
PF-04937319 high dose has completed three clinical trials. NCT02292433 was a Phase 1 study in Japanese subjects with Type 2 Diabetes Mellitus. NCT03181893 was a Phase 2 study in adults with moderate to severe Dermatomyositis. NCT03256526 was a Phase 2 study in adults with NAFLD.
PF-04937319 high dose is not FDA approved. It is an investigational drug in clinical development, with completed Phase 1 and Phase 2 trials. No approval status has been reported for this drug.