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Sisunatovir

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: May 6, 2025

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
RandomizedDouble-BlindACTIVE_CONTROLLEDBiomarker
Total Trials3
Total Enrollment108
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06105983A Study to Learn How a Medicine That Reduces Stomach Acid Affects the Level of Sisunatovir in the Blood of Healthy Adults.PHASE1 COMPLETED 40Nov 3, 2023Jul 19, 2024Apr 24, 20251 Belgium
NCT05994963A Study to Compare Different Preparations of Sisunatovir in Healthy Adult Participants.PHASE1 COMPLETED 25Sep 1, 2023Feb 26, 2024May 6, 20251 Belgium
NCT05878522A Study to Investigate the Effects of Sisunatovir on QTc Interval in Healthy Adult Participants.PHASE1 COMPLETED 43May 15, 2023Oct 30, 2023Dec 6, 20241 United States
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Study Endpoints
Primary Endpoints
Maximum Observed Plasma Concentration (Cmax)
0 to 72 hour postdose
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)
0 to 72 hours postdose

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

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
0 to 72 hours postdose

Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

Area Under the Concentration-Time Curve From Time Zero to The Time of The Last Quantifiable Concentration (AUClast) of Sisunatovir PIC Versus (vs) WGT in a Fasted State, Part 1
Pre-dose (0 hour), 1, 2, 3, 4, 5, 6, 8, 10,12 hours post-dose on Day 1; 24, 36 hours post-dose on Day 2; 48 hours post-dose on Day 3 of Period 1-3; 72 hours post-dose on Day 4 of period 3

AUClast was calculated using linear/log trapezoidal method. Treatment A = sisunatovir 200 mg PIC under fasted condition; reference treatment. Treatment B = sisunatovir 200 mg WGT under fasted condition; test treatment.

Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of Sisunatovir PIC vs WGT in Fasted State, Part 1
Pre-dose (0 hour), 1, 2, 3, 4, 5, 6, 8, 10,12 hours post-dose on Day 1; 24, 36 hours post-dose on Day 2; 48 hours post-dose on Day 3 of Period 1-3; 72 hours post-dose on Day 4 of period 3

AUCinf was calculated as AUClast + (Clast\*/kel), where Clast is the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis, and kel is the terminal phase rate constant calculated by a linear regression of the loglinear concentration-time curve. Treatment A = sisunatovir 200 mg PIC under fasted condition; reference treatment. Treatment B = sisunatovir 200 mg WGT under fasted condition; test treatment.

Maximum Plasma Concentration (Cmax) of Sisunatovir PIC vs WGT in a Fasted State, Part 1
Pre-dose (0 hour), 1, 2, 3, 4, 5, 6, 8, 10,12 hours post-dose on Day 1; 24, 36 hours post-dose on Day 2; 48 hours post-dose on Day 3 of Period 1-3; 72 hours post-dose on Day 4 of period 3

Treatment A = sisunatovir 200 mg PIC under fasted condition; reference treatment. Treatment B = sisunatovir 200 mg WGT under fasted condition; test treatment.

Placebo-Adjusted Change From Baseline in QT Interval Corrected Using Fridericia's Formula (QTcF) at Expected Maximum Concentration (Cmax) on Day 3 for Sisunatovir
Baseline, Day 3

The relationship between sisunatovir plasma concentration and change from baseline in Fridericia's heart-rate corrected QT interval were analyzed using a model-based concentration-QTc analysis consistent with the Scientific White Paper on Concentration-QT Modeling. Baseline was defined as the mean of the 3 averages of the triplicate electrocardiogram (ECG) measurements taken before dosing on Day 1 within each period. Mean and CI statistics were based on the individual (within subject) corrected differences between sisunatovir and placebo exposures.

Secondary Endpoints
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
Baseline up to 35 days after last dose of study intervention
Number of Participants With Clinical Laboratory Abnormalities
Baseline to Study Day 12 (Part 1) or Study Day 20 (Part 2)
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Baseline to Study Day 12 (Part 1) or Study Day 20 (Part 2)
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER
Treatment Arms
ArmTypeDescription
Treatment AEXPERIMENTALPart 1: Sisunatovir without rabeprazole
Treatment BACTIVE_COMPARATORPart 1: Sisunatovir with 40 mg rabeprazole
Treatment CACTIVE_COMPARATORPart 2: Sisunatovir suspension without rabeprazole
Treatment DEXPERIMENTALPart 2: Sisunatovir suspension with 20 mg rabeprazole
Treatment EEXPERIMENTALPart 2: Sisunatovir suspension with 40 mg rabeprazole
Part 1 Treatment AEXPERIMENTAL4 capsules of sisunatovir in fasted state
Part 1 Treatment BEXPERIMENTAL2 tablets of sisunatovir in fasted state
Part 1 Treatment CEXPERIMENTAL2 tablets of sisunatovir with a high-fat meal
Part 2 Treatment BEXPERIMENTAL2 tablets of sisunatovir in fasted sate
Part 2 Treatment DEXPERIMENTAL2 tablets of sisunatovir with a low-fat meal
Interventions
NameTypeDescription
SisunatovirDRUGSingle Dose
Rabeprazole 40 mgDRUGTablets once daily for 7 days
Sisunatovir suspensionDRUGTablets once daily for 7 days
Rabeprazole 20 mgDRUGTablets once daily for 7 days
placeboDRUG6 capsules administered Q12 hours for 5 doses
moxifloxacinDRUG6 capsules of placebo administered Q12 hours for 4 doses, followed by a single tablet of moxifloxacin
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male and female participants aged 18 years or older (or the minimum age of consent in accordance with local regulations) at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, blood pressure, ...

Countries:BelgiumUnited States
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