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PF-06882961 followed by PF-06882961/PF-06865571

Phase 1

Healthy Volunteer | Small molecule | Other |Pfizer, Inc.|Last Updated: Aug 21, 2023

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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment27
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04839393A Drug-Drug Interaction Study Between PF-06882961 and PF-06865571 in Healthy Adult Participants and Overweight Adults or Adults With Obesity Who Are Otherwise HealthyPHASE1 COMPLETED 27 — — Apr 5, 2021Nov 8, 2021Aug 21, 20231 United States
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Study Endpoints
Primary Endpoints
Part A: PF-06882961 Maximum Observed Concentration (Cmax)
0 (prior to dosing), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1

Cmax for PF-06882961 was observed directly from data.

Part A: PF-06882961 Area Under the Plasma Concentration-time Profile From Time 0 to the Time 24 Hours Post-dose (AUC24)
0 (prior to dosing), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1

AUC24 for PF-06882961 was determined by Linear/Log trapezoidal method.

Part B: PF-06865571 Cmax on Day 1 and Day 47
0 (prior to dosing), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24 and 48 hours post-dose

Cmax for PF-06865571 was observed directly from data on Day 1 and Day 47.

Part B: PF-06865571 Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) on Day 1 and Day 47
0 (prior to dosing), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24 and 48 hours post-dose

AUClast for PF-06865571 was determined by Linear/Log trapezoidal method on Day 1 and Day 47.

Part B: PF-06865571 Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) on Day 1 and Day 47
0 (prior to dosing), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24 and 48 hours post-dose

AUCinf for PF-06865571 was calculated as AUClast + (Clast\*/kel) on Day 1 and Day 47. Clast\* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis and kel was the elimination rate constant.

Part B: PF-06882961 Cmax on Day 46 and Day 61
0 (prior to dosing), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-dose

Cmax for PF-06882961 was observed directly from data on Day 46 and Day 61.

Part B: PF-06882961 Area Under the Plasma Concentration-time Profile From Time 0 to the Time 12 Hours Post-dose (AUC12) on Day 46 and Day 61
0 (prior to dosing), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-dose

AUC 12 for PF-06882961 was determined by Linear/Log trapezoidal method on Day 46 and Day 61.

Secondary Endpoints
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in Part A
Up to 68 days
Number of Participants With Clinical Laboratory Abnormalities in Part A
From Screening (28 days prior to the day of treatment) to Day 2 of Period 2, for a maximum of 33 Days
Number of Participants With Vital Signs Data Meeting Pre-specified Criteria in Part A
From Screening (28 days prior to the day of treatment) to Day 2 of Period 2, for a maximum of 33 Days
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Part A - Sequence 1EXPERIMENTALTreatment A - PF-06882961 single dose followed by Treatment B - PF-06882961 single dose and PF-06865571 single dose
Part A - Sequence 2EXPERIMENTALTreatment B - PF-06882961 single dose and PF-06865571 single dose followed by Treatment A - PF-06882961 single dose
Part BEXPERIMENTALPeriod 1: PF-06865571 single dose, Period 2: PF-06882961 twice daily dose titration, Period 3: PF-06865571 single dose and PF-06882961 twice daily dosing, Period 4: PF-06865571 twice daily dosing and PF-06882961 twice daily dosing
Interventions
NameTypeDescription
PF-06882961 followed by PF-06882961/PF-06865571DRUGTreatment A - PF-06882961 20 mg single dose followed by Treatment B - PF-06882961 20 mg single dose plus PF-06865571 300 mg single dose. There will be a washout interval between periods of at least 3 days.
PF-06882961/PF-06865571 followed by PF-06882961DRUGTreatment B - PF-06882961 20 mg single dose plus PF-06865571 300 mg single dose followed by Treatment A - PF-06882961 20 mg single dose. There will be a washout interval between periods of at least 3 days.
PF-06882961 + PF-06865571DRUGPeriod 1: PF-06865571 300 mg single dose (Day 1), Period 2: PF-06882961 10 mg twice daily dose titration up to 200 mg twice daily dosing (Days 3-46), Period 3: PF-06865571 300 mg single dose (Day 47) and PF-06882961 200 mg twice daily dosing (Days 47-48), Period 4: PF-06865571 300 mg twice daily dosing and PF-06882961 200 mg twice daily dosing (Days 49-62)
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Male and female participants must be 18 to 65 years of age, inclusive, at the time of signing the ICD. Women can be of child-bearing potential, however, cannot be pregnant, breastfeeding, or planning to become pregnant while participating in the study. 2. Male and female ...

Countries:United States
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