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PF-07923568

Phase 1

Liver Diseases | Small molecule | Gastrointestinal |Pfizer, Inc.|Last Updated: Mar 21, 2025

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment28

FDA Designations

No designations recorded

Clinical trial landscape

PF-07923568 · 1 trial · 2 indications

Phase 1 1
NCT05857644A Study to Compare How the Study Medicine (PF-07923568) is Processed in Participants With Different Levels of Loss of Liver Function to Healthy Participants.Liver Diseases
COMPLETED28 Analytics
PHASE1COMPLETED
A Study to Compare How the Study Medicine (PF-07923568) is Processed in Participants With Different Levels of Loss of Liver Function to Healthy Participants.
Liver DiseasesUnlock trial analytics

Study Endpoints

Primary Endpoints

Plasma Maximum Concentration (Cmax) of Sisunatovir Following Administration of a Single Oral Dose
Hours 0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, and 120 postdose from Day 1 to Day 6

Cmax was the highest concentration observed directly from data

Area Under the Plasma Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Sisunatovir Following Administration of a Single Oral Dose
Hours 0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, and 120 postdose from Day 1 to Day 6

AUClast was determined using linear/Log trapezoidal method

Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Sisunatovir Following Administration of a Single Oral Dose
Hours 0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, and 120 postdose from Day 1 to Day 6

AUClast + (Clast\*/kel), where Clast\* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis and kel was the terminalphase rate constant.

Secondary Endpoints

Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Treatment-related TEAEs, and Discontinuations From Study Due to TEAEs
Day -1 through follow-up (Day 29-36)
Number of Participants With Laboratory Test Abnormalities
Day -1 and Day 6
Number of Participants With Vital Signs Meeting Categorical Criteria
Day -1, Day 1, Day 2, and Day 6
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Healthy subjectsEXPERIMENTALOne time dose of 4 capsules taken orally.
Mild Hepatic impaired subjectsEXPERIMENTALOne time dose of 4 capsules taken orally.
Moderate hepatic impaired subjectsEXPERIMENTALOne time dose of 4 capsules taken orally
Severe Hepatic Impaired SubjectsEXPERIMENTALOne time dose of 4 capsules taken orally.

Interventions

NameTypeDescription
PF-07923568DRUGOne time dose of 4 capsules taken orally.
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: for healthy volunteers: * BMI of 17.5 to 38.0 kg/m2, inclusive, and a total body weight \>50 kg (110 lb). * Capable of giving signed informed consent. * At screening, no clinically relevant abnormalities identified by a detailed medical history, complete physical examination, in...

Countries:United States
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Frequently asked questions about PF-07923568

What is PF-07923568 used for?

PF-07923568 is an investigational small molecule being developed by Pfizer for liver diseases, specifically studied in the context of hepatic impairment. It is currently in Phase 1 clinical development and is not approved by the FDA.

Who makes PF-07923568?

PF-07923568 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 for liver diseases.

What phase is PF-07923568 in?

PF-07923568 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. A Phase 1 study has been completed to evaluate how the drug is processed in participants with different levels of liver function.

What clinical trials is PF-07923568 in?

PF-07923568 has one completed Phase 1 clinical trial, identified as NCT05857644. This study compared how the drug is processed in participants with different levels of loss of liver function versus healthy participants. The trial enrolled 28 participants in the United States.

How does PF-07923568 work?

The specific molecular target or mechanism of action for PF-07923568 has not been disclosed. It is a small molecule being studied for its effects in liver diseases, with a focus on how it is processed in individuals with hepatic impairment.