Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PF-07202954 Repeat Dose · 1 trial · 2 indications
An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. TEAEs were AEs that occurred following the start of study treatment (either PF-07202954 or placebo) up to approximately 28 days after the last dose.
Pre-defined criteria for laboratory abnormalities included, hematology: neutrophils/leukocytes (less than \[\<\] 0.8\* lower limit normal \[LLN\]); monocytes/leukocytes (greater than \[\>\] 1.2\* upper limit normal \[ULN\]); clinical chemistry: low density lipoprotein (LDL) (\>1.2\*ULN), creatine kinase (\>2.0\*ULN); and urinalysis: specific gravity (\<1.003); ketones, urine protein, urine hemoglobin, nitrite (greater than equal to \[\>=1\]), urine erythrocytes (\>= 20), red blood cells (RBC) casts (\>1), bacteria (\>20). Number of participants with any laboratory abnormality meeting pre-defined criteria was reported in this outcome measure.
Vital signs were categorized according to the following criteria for potential clinical concern: diastolic blood pressure (DBP): \<50 millimeter of mercury (mmHg), increase from baseline \>= 20mmHg; systolic blood pressure (SBP): \<90 mmHg, increase from baseline \>=30mmHg; pulse rate: \<40 beats per minute (bpm), \>120 bpm.
ECG parameters were categorized according to the following criteria for potential clinical concern: PR interval aggregate (msec) \>=300, percent change \>=25/50 percent (%); QRS duration, aggregate (msec) \>=140, percent change \>= 50%; QT interval corrected by Fridericia's formula (QTcF) interval aggregate (msec): \>450 to \<=480, \> 480 to \<=500, \>500, change from baseline: \>30 to \<=60 and change \>60.
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Pre-defined criteria for laboratory abnormalities included, hematology: neutrophils/leukocytes (\<0.8\* LLN); monocytes/leukocytes (\>1.2\* ULN); clinical chemistry: LDL (\>1.2\*ULN), creatine kinase (\>2.0\*ULN); and urinalysis: specific gravity (\<1.003); ketones, urine protein, urine hemoglobin, nitrite (\>=1), urine erythrocytes (\>=20), RBC casts (\>1), bacteria (\>20).
Vital signs were planned to be categorized according to the following criteria for potential clinical concern: diastolic blood pressure: \<50 mmHg, increase from baseline \>=20mmHg; systolic blood pressure: \<90 mmHg, increase from baseline \>=30mmHg; pulse rate: \<40 bpm, \>120 bpm.
ECG parameters were planned to be categorized according to the following criteria for potential clinical concern: PR interval aggregate (msec) \>=300, percent change \>=25/50%; QRS duration, aggregate (msec) \>=140, percent change \>=50%; QTcF interval aggregate (msec): \>450 to \<=480, \>480 to \<=500, \>500, change from baseline: \>30 to \<=60 and change \>60.
AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf).
| Arm | Type | Description |
|---|---|---|
| Part 1 | EXPERIMENTAL | Single, Escalating Doses of PF-07202954 or Placebo (Cohorts 1 and 2) |
| Part 2 | EXPERIMENTAL | Repeated, Escalating Doses of PF-07202954 or placebo from Day 1 to Day 14, inclusive (Cohorts 3, 4, 5, 6 7, and optional Cohort 8) |
| Part 3 | EXPERIMENTAL | Single dose of PF-07202954 with a high-fat/high-caloric meal and a single dose following an overnight fast of ≥10 hours |
| Name | Type | Description |
|---|---|---|
| PF-07202954 Repeat Dose | DRUG | 10, 30, 100, 300, 600, 1200 milligrams (mg) |
| PF-07202954 Single Dose | DRUG | 10, 30, 100, 300, 600, 900, 1200 milligrams (mg) |
| Placebo | DRUG | Matching Placebo |
Inclusion Criteria:- healthy subjects (all 3 Parts) * evidence of steatosis on FibroScan (Part 2 only) * BMI 17.5 to 30.5 kg/m2 (Part 1, Part 3) * BMI 17.5 to 35.4 kg/m2 (Part 2) Exclusion Criteria:- evidence of clinically significant disease * subjects on chronic medications * clinically significa...
PF-07202954 Repeat Dose is an investigational small molecule being studied for the treatment of Non-Alcoholic Fatty Liver Disease (NAFLD). It is being developed by Pfizer, Inc. and is currently in Phase 1 clinical development. The drug is intended to address liver fibrosis associated with NAFLD.
PF-07202954 Repeat Dose is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is an investigational small molecule in Phase 1 clinical development for Non-Alcoholic Fatty Liver Disease.
PF-07202954 Repeat Dose is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and efficacy in humans.
PF-07202954 Repeat Dose has been studied in one completed Phase 1 clinical trial, identified as NCT04857437. This trial, titled 'Study in Healthy Adults Evaluating PF-07202954', enrolled 12 participants in the United States and evaluated the drug in healthy volunteers.
PF-07202954 Repeat Dose is a formulation or regimen of the investigational drug PF-07202954. The clinical trial NCT04857437 evaluated PF-07202954 in a repeat-dose setting, which is reflected in the drug name. Both refer to the same investigational compound being developed by Pfizer.