Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PF-07293893 · 3 trials · 1 indication
An Adverse event (AE) was any untoward medical occurrence in a participant or clinical trial participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were events with onset dates on or after the start of the study drug.
Following parameters were analyzed for laboratory abnormalities: hematology (lymphocytes \<0.8\*lower limit of normal \[LLN\], lymphocytes/leukocytes \<0.8\*LLN, neutrophils \<0.8\*LLN, neutrophils/leukocytes \<0.8\*LLN, eosinophils/leukocytes \>1.2\*upper limit of normal \[ULN\], monocytes \>1.2\*ULN, monocytes/leukocytes \>1.2\*ULN); clinical chemistry (aspartate aminotransferase \>3.0\*ULN, potassium \>1.1\*ULN, creatine kinase \>2.0\*ULN); urinalysis (urine specific gravity \<1.003 ,\>1.030, ketones \>=1, urine hemoglobin \>=1, urobilinogen \>=1, urine bilirubin \>=1, leukocyte esterase \>=1). In this outcome measure, participants with any laboratory abnormalities are reported.
Vital signs assessments included blood pressure, pulse rate, respiratory rate and body temperature. Clinical significance of vital signs was determined based by investigator's discretion.
ECG parameters included heart rate, PR interval, QTc corrected using Fridericia's formula (QTcF) and QRS complex. Clinically significant ECG findings were determined by the investigator's discretion.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Healthy adult participants will receive a single dose of PF-07293893 or placebo |
| Optional Cohort 2 | EXPERIMENTAL | Healthy adult participants will receive a single dose of PF-07293893 or placebo |
| PF-07293893 and Placebo (Cohort 1) | EXPERIMENTAL | Dose level 1: Multiple dose administration of PF-07293893 and placebo over 14 days in healthy participants; 6 participants will receive PF-07293893 and 2 will receive placebo. |
| PF-07293893 and Placebo (Cohort 2) | EXPERIMENTAL | Dose level 2: Multiple dose administration of PF-07293893 and placebo over 14 days in healthy participants; 6 participants will receive PF-07293893 and 2 will receive placebo. |
| PF-07293893 and Placebo (Cohort 3) | EXPERIMENTAL | Dose level 3: Multiple dose administration of PF-07293893 and placebo over 14 days in healthy participants; 6 participants will receive PF-07293893 and 2 will receive placebo. |
| PF-07293893 and Placebo (Cohort 4) | EXPERIMENTAL | Dose level 4: Multiple dose administration of PF-07293893 and placebo over 14 days in healthy participants; 6 participants will receive PF-07293893 and 2 will receive placebo. |
| PF-07293893 and Placebo (Cohort 5) | EXPERIMENTAL | Dose level 5: Multiple dose administration of PF-07293893 and placebo over 14 days in healthy participants; 6 participants will receive PF-07293893 and 2 will receive placebo. |
| PF-07293893 and Placebo (Cohort 6, Optional) | EXPERIMENTAL | Dose level 6: Multiple dose administration of PF-07293893 and placebo over 14 days in healthy participants; 6 participants will receive PF-07293893 and 2 will receive placebo. |
| Midazolam drug-drug interaction (Cohort 7, Optional) | EXPERIMENTAL | Drug-drug interaction assessment of pharmacokinetics interaction in PF-07293893 and midazolam |
| Metabolism and elimination of PF-07293893 (Cohort 8, Optional) | EXPERIMENTAL | Determination of excretion routes and metabolite profiling of PF-07293893. |
| Skeletal muscle imaging (Cohort 8, optional) | EXPERIMENTAL | Evaluation of the effect of 14-days of daily PF-07293893 on skeletal muscle glycogen in healthy adult participants |
| Name | Type | Description |
|---|---|---|
| PF-07293893 | DRUG | A single dose of PF-07293893 administered orally as tablets |
| Placebo | DRUG | A single dose of Placebo administered orally as tablets that look the same as PF-07293893 |
| Midazolam | DRUG | Single doses of Midazolam will be administered as oral solution alone and in combination with PF-07293893 |
Inclusion Criteria: 1. Males 18 to 65 years of age and females of non-childbearing potential; 2. Body mass index (BMI) of 16 to 32 kg/m2; and a total body weight \>50 kg (110 lb); 3. Over prior 4 weeks an average of less than 150 minutes of moderate-intensity aerobic physical activity throughout ea...
PF-07293893 is an investigational small molecule being studied in healthy participants. It is currently in Phase 1 clinical development, with completed trials evaluating its safety, tolerability, and effects on muscle biomarkers in healthy adults. It is not approved for any indication.
PF-07293893 is being developed by Pfizer, Inc. (NYSE: PFE). The company has conducted Phase 1 clinical trials of the drug in healthy adult participants.
PF-07293893 is in Phase 1 clinical development. All three of its clinical trials, which were conducted in healthy participants, have been completed. The drug is investigational and has not been approved by regulatory authorities.
PF-07293893 has been studied in three completed Phase 1 trials: NCT05907395, a single ascending dose study in Belgium; NCT06177457, a multiple ascending dose study in the United States and Belgium; and NCT06413693, a study of its effects on muscle biomarkers in the United States.
PF-07293893 is not FDA approved. It is an investigational drug that has completed Phase 1 clinical trials in healthy participants. Its safety and efficacy have not been established, and it remains in clinical development.