| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04857437 | Study in Healthy Adults Evaluating PF-07202954 | PHASE1 | COMPLETED | 12 | — | — | May 13, 2021 | Sep 17, 2021 | Sep 20, 2024 | 1 | United States |
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...