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PF-07202954 Repeat Dose

Phase 1

Non-Alcoholic Fatty Liver Disease | Small molecule | Metabolic |Pfizer, Inc.|Last Updated: Sep 20, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLED
Total Trials1
Total Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04857437Study in Healthy Adults Evaluating PF-07202954PHASE1 COMPLETED 12May 13, 2021Sep 17, 2021Sep 20, 20241 United States
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Study Endpoints
Primary Endpoints
Number of Participants With Treatment Emergent Adverse Events (TEAEs): Part 1
From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks)

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.

Number of Participants With Laboratory Abnormalities Meeting Pre-defined Criteria: Part 1
From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks)

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.

Number of Participants According to Categorization of Vital Signs Data: Part 1
From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks)

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.

Number of Participants According to Categorization of Electrocardiogram (ECG) Data: Part 1
From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks)

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.

Number of Participants With TEAEs: Part 2
Up to a maximum of 12 weeks

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.

Number of Participants With Laboratory Abnormalities Meeting Pre-defined Criteria: Part 2
Up to a maximum of 12 weeks

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).

Number of Participants According to Categorization of Vital Signs Data: Part 2
Up to a maximum of 12 weeks

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.

Number of Participants According to Categorization of ECG Data: Part 2
Up to a maximum of 12 weeks

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.

Maximum Observed Plasma Concentration (Cmax) of PF-07202954: Part 3
Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post-dose)
Time for Cmax (Tmax) of PF-07202954: Part 3
Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post-dose)
Area Under the Plasma Concentration Time Profile From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of PF-07202954: Part 3
Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post-dose)
Area Under the Plasma Concentration Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-07202954: Part 3
Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post-dose)

AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf).

Secondary Endpoints
Maximum Observed Plasma Concentration (Cmax) of PF-07202954: Part 1
Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post-dose)
Time for Cmax (Tmax) of PF-07202954: Part 1
Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post-dose)
Area Under the Plasma Concentration Time Profile From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of PF-07202954: Part 1
Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post-dose)
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Part 1EXPERIMENTALSingle, Escalating Doses of PF-07202954 or Placebo (Cohorts 1 and 2)
Part 2EXPERIMENTALRepeated, 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 3EXPERIMENTALSingle dose of PF-07202954 with a high-fat/high-caloric meal and a single dose following an overnight fast of ≥10 hours
Interventions
NameTypeDescription
PF-07202954 Repeat DoseDRUG10, 30, 100, 300, 600, 1200 milligrams (mg)
PF-07202954 Single DoseDRUG10, 30, 100, 300, 600, 900, 1200 milligrams (mg)
PlaceboDRUGMatching Placebo
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

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...

Countries:United States
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