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Adjusted LOA
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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 developed by Pfizer, Inc. (ticker PFE). It is in Phase 1 clinical development, and its specific therapeutic indication has not been disclosed. All three of its reported Phase 1 trials were conducted in healthy adult participants rather than in patients with a named disease.
PF-07293893 is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer is the sponsor of the three Phase 1 trials registered for this compound, all of which were run in healthy adult volunteers in the United States and Belgium.
PF-07293893 is in Phase 1 clinical development. Three Phase 1 trials have been registered, and all three are listed as completed. The program has not advanced beyond Phase 1, and no later-stage trials for PF-07293893 have been reported.
Three completed Phase 1 trials are registered for PF-07293893: NCT06413693, which examined muscle biomarkers in 31 healthy adults in the United States; NCT06177457, a multiple ascending dose study in 88 healthy adults in the United States and Belgium; and NCT05907395, a dose-level study in 30 healthy adults in Belgium.
Across the three completed Phase 1 trials, 149 participants were enrolled: 31 in NCT06413693, 88 in NCT06177457, and 30 in NCT05907395. All participants were healthy adults aged 18 years and older, and the studies enrolled both male and female volunteers.
Yes. The Phase 1 trials for PF-07293893 used a randomized, double-blind, controlled design. The studies enrolled healthy adult volunteers rather than patients, and none of the trials used biomarker-based patient selection. All three registered trials are listed as completed.