Recent Updates
Recently added Catalysts

Sinsunatovir

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Nov 13, 2024

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Clinical trial landscape

Sinsunatovir · 1 trial · 1 indication

Phase 1 1
NCT06003829A Study to Learn About the Tastes of Different Suspensions With the Study Medicine (PF-07923568) in Healthy Adult Participants.Healthy
COMPLETED12 Analytics
PHASE1COMPLETED
A Study to Learn About the Tastes of Different Suspensions With the Study Medicine (PF-07923568) in Healthy Adult Participants.
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 1 Minute Post-dose on Day 1
At 1 minute after tasting specified study formulation on Day 1

Participants were offered formulation for tasting where they had to swirl sample in their mouth for approximately 10 seconds, and then spit it out. Participant had to assess each sensory attribute on scale of 0 (good) to 100 (bad) after tasting formulation, lower score= better palatability. Following were sensory attributes: mouth feel (grittiness/stickiness or waxiness, 0= normal mouth feel,100=bad mouth feel);bitterness (degree of bitterness of the product, 0= not bitter at all,100= extremely bitter); sweetness(degree of sweet taste,0=sweet, 100= not sweet at all); sourness (degree of sour taste,0= not sour at all,100= extremely sour);saltiness(degree of salty taste,0=not salty at all,100= extremely salty); tongue/mouth burn(degree of tongue/mouth burn,0= no burn at all,100= extreme burn);overall liking (how much like or dislike product, 0= like, 100= dislike).Mean score for each sensory attributes based on palatability assessment questionnaire are reported in this outcome measure.

Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 5 Minutes Post-dose on Day 1
At 5 minutes after tasting specified study formulation on Day 1

Participants were offered formulation for tasting where they had to swirl sample in their mouth for approximately 10 seconds, and then spit it out. Participant had to assess each sensory attribute on scale of 0 (good) to 100 (bad) after tasting formulation, lower score= better palatability. Following were sensory attributes: mouth feel (grittiness/stickiness or waxiness, 0= normal mouth feel,100=bad mouth feel);bitterness (degree of bitterness of the product, 0= not bitter at all,100= extremely bitter); sweetness(degree of sweet taste,0=sweet, 100= not sweet at all); sourness (degree of sour taste,0= not sour at all,100= extremely sour);saltiness(degree of salty taste,0=not salty at all,100= extremely salty); tongue/mouth burn(degree of tongue/mouth burn,0= no burn at all,100= extreme burn);overall liking (how much like or dislike product, 0= like, 100= dislike).Mean score for each sensory attributes based on palatability assessment questionnaire are reported in this outcome measure.

Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 10 Minutes Post-dose on Day 1
At 10 minutes after tasting specified study formulation on Day 1

Participants were offered formulation for tasting where they had to swirl sample in their mouth for approximately 10 seconds, and then spit it out. Participant had to assess each sensory attribute on scale of 0 (good) to 100 (bad) after tasting formulation, lower score= better palatability. Following were sensory attributes: mouth feel (grittiness/stickiness or waxiness, 0= normal mouth feel,100=bad mouth feel);bitterness (degree of bitterness of the product, 0= not bitter at all,100= extremely bitter); sweetness(degree of sweet taste,0=sweet, 100= not sweet at all); sourness (degree of sour taste,0= not sour at all,100= extremely sour);saltiness(degree of salty taste,0=not salty at all,100= extremely salty); tongue/mouth burn(degree of tongue/mouth burn,0= no burn at all,100= extreme burn);overall liking (how much like or dislike product, 0= like, 100= dislike).Mean score for each sensory attributes based on palatability assessment questionnaire are reported in this outcome measure.

Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 20 Minutes Post-dose on Day 1
At 20 minutes after tasting specified study formulation on Day 1

Participants were offered formulation for tasting where they had to swirl sample in their mouth for approximately 10 seconds, and then spit it out. Participant had to assess each sensory attribute on scale of 0 (good) to 100 (bad) after tasting formulation, lower score= better palatability. Following were sensory attributes: mouth feel (grittiness/stickiness or waxiness, 0= normal mouth feel,100=bad mouth feel);bitterness (degree of bitterness of the product, 0= not bitter at all,100= extremely bitter); sweetness(degree of sweet taste,0=sweet, 100= not sweet at all); sourness (degree of sour taste,0= not sour at all,100= extremely sour);saltiness(degree of salty taste,0=not salty at all,100= extremely salty); tongue/mouth burn(degree of tongue/mouth burn,0= no burn at all,100= extreme burn);overall liking (how much like or dislike product, 0= like, 100= dislike).Mean score for each sensory attributes based on palatability assessment questionnaire are reported in this outcome measure.

Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 1 Minute Post-dose on Day 2
At 1 minute after tasting specified study formulation on Day 2

Participants were offered formulation for tasting where they had to swirl sample in their mouth for approximately 10 seconds, and then spit it out. Participant had to assess each sensory attribute on scale of 0 (good) to 100 (bad) after tasting formulation, lower score= better palatability. Following were sensory attributes: mouth feel (grittiness/stickiness or waxiness, 0= normal mouth feel,100=bad mouth feel);bitterness (degree of bitterness of the product, 0= not bitter at all,100= extremely bitter); sweetness(degree of sweet taste,0=sweet, 100= not sweet at all); sourness (degree of sour taste,0= not sour at all,100= extremely sour);saltiness(degree of salty taste,0=not salty at all,100= extremely salty); tongue/mouth burn(degree of tongue/mouth burn,0= no burn at all,100= extreme burn);overall liking (how much like or dislike product, 0= like, 100= dislike).Mean score for each sensory attributes based on palatability assessment questionnaire are reported in this outcome measure.

Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 5 Minutes Post-dose on Day 2
At 5 minutes after tasting specified study formulation on Day 2

Participants were offered formulation for tasting where they had to swirl sample in their mouth for approximately 10 seconds, and then spit it out. Participant had to assess each sensory attribute on scale of 0 (good) to 100 (bad) after tasting formulation, lower score= better palatability. Following were sensory attributes: mouth feel (grittiness/stickiness or waxiness, 0= normal mouth feel,100=bad mouth feel);bitterness (degree of bitterness of the product, 0= not bitter at all,100= extremely bitter); sweetness(degree of sweet taste,0=sweet, 100= not sweet at all); sourness (degree of sour taste,0= not sour at all,100= extremely sour);saltiness(degree of salty taste,0=not salty at all,100= extremely salty); tongue/mouth burn(degree of tongue/mouth burn,0= no burn at all,100= extreme burn);overall liking (how much like or dislike product, 0= like, 100= dislike).Mean score for each sensory attributes based on palatability assessment questionnaire are reported in this outcome measure.

Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 10 Minutes Post-dose on Day 2
At 10 minutes after tasting specified study formulation on Day 2

Participants were offered formulation for tasting where they had to swirl sample in their mouth for approximately 10 seconds, and then spit it out. Participant had to assess each sensory attribute on scale of 0 (good) to 100 (bad) after tasting formulation, lower score= better palatability. Following were sensory attributes: mouth feel (grittiness/stickiness or waxiness, 0= normal mouth feel,100=bad mouth feel);bitterness (degree of bitterness of the product, 0= not bitter at all,100= extremely bitter); sweetness(degree of sweet taste,0=sweet, 100= not sweet at all); sourness (degree of sour taste,0= not sour at all,100= extremely sour);saltiness(degree of salty taste,0=not salty at all,100= extremely salty); tongue/mouth burn(degree of tongue/mouth burn,0= no burn at all,100= extreme burn);overall liking (how much like or dislike product, 0= like, 100= dislike).Mean score for each sensory attributes based on palatability assessment questionnaire are reported in this outcome measure.

Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 20 Minutes Post-dose on Day 2
At 20 minutes after tasting specified study formulation on Day 2

Participants were offered formulation for tasting where they had to swirl sample in their mouth for approximately 10 seconds, and then spit it out. Participant had to assess each sensory attribute on scale of 0 (good) to 100 (bad) after tasting formulation, lower score= better palatability. Following were sensory attributes: mouth feel (grittiness/stickiness or waxiness, 0= normal mouth feel,100=bad mouth feel);bitterness (degree of bitterness of the product, 0= not bitter at all,100= extremely bitter); sweetness(degree of sweet taste,0=sweet, 100= not sweet at all); sourness (degree of sour taste,0= not sour at all,100= extremely sour);saltiness(degree of salty taste,0=not salty at all,100= extremely salty); tongue/mouth burn(degree of tongue/mouth burn,0= no burn at all,100= extreme burn);overall liking (how much like or dislike product, 0= like, 100= dislike).Mean score for each sensory attributes based on palatability assessment questionnaire are reported in this outcome measure.

Secondary Endpoints

Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Day 1 of receiving formulation up to 35 days after last formulation of the study (up to 37 days)
Number of Participants With Clinically Significant Laboratory Abnormalities
1 day prior to first formulation (Day -1) up to last formulation on Day 2 (up to 3 days)
Number of Participants With Clinically Significant Vital Signs Abnormalities
Day 1 of receiving formulation up to last formulation on Day 2 (up to 2 days)
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
Treatment AEXPERIMENTAL -
Treatment BEXPERIMENTAL -
Treatment COTHERComparator
Treatment DEXPERIMENTAL -
Treatment EEXPERIMENTAL -
Treatment FEXPERIMENTAL -

Interventions

NameTypeDescription
SinsunatovirDRUGSingle dose, to be spit out after tasting
BitrexOTHERSingle dose, to be spit out after tasting
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 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:Belgium
Unlock Eligibility Criteria

Frequently asked questions about Sinsunatovir

What is Sinsunatovir?

Sinsunatovir is an investigational small molecule being developed by Pfizer, Inc. (PFE). It is currently in Phase 1 clinical development. The drug is being studied for use in healthy participants, and it has completed one clinical trial.

What is Sinsunatovir used for?

Sinsunatovir is being studied for use in healthy participants. It is currently in Phase 1 clinical development. The drug is an investigational small molecule, and its safety and tolerability are being evaluated in early-stage trials.

Who makes Sinsunatovir?

Sinsunatovir is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is currently in Phase 1 clinical development.

What phase is Sinsunatovir in?

Sinsunatovir is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and the drug is being studied in healthy participants.

What clinical trials is Sinsunatovir in?

Sinsunatovir has been studied in one completed clinical trial, NCT06003829. This Phase 1 study, titled "A Study to Learn About the Tastes of Different Suspensions With the Study Medicine (PF-07923568) in Healthy Adult Participants," enrolled 12 healthy adults in Belgium.

Is Sinsunatovir the same as PF-07923568?

Yes, Sinsunatovir is also known as PF-07923568. In clinical trial NCT06003829, the study medicine is referred to as PF-07923568, which is the same drug as Sinsunatovir.