NCT05857644

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.

A PHASE 1, OPEN-LABEL, SINGLE-DOSE, PARALLEL GROUP STUDY TO COMPARE THE PHARMACOKINETICS OF PF-07923568 IN ADULT PARTICIPANTS WITH VARYING DEGREES OF HEPATIC IMPAIRMENT RELATIVE TO PARTICIPANTS WITHOUT HEPATIC IMPAIRMENT

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to learn how the study medicine (PF-07923568) is processed in participants with liver function loss compared to healthy participants. The different levels of liver function loss can be mild, moderate or severe. This study is seeking participants who: * are male or female of 18 years of age or older. * are examined to be healthy (group with no loss of liver function). * have mild, moderate, and severe liver disease (group with loss of liver function). All participants will receive a one-time dose of 4 capsules of PF-07923568 which will be taken by mouth. All participants will remain at the study clinic for 6 days for safety review and laboratory collections. This is to see how the study medicine is being broken down by the liver over time. All participants selected in the study will be required to go through a screening period up to 28 days. A screening period is the time during which a few participants are examined to see whether they are fit for the study. During this period, the participant's medical history and past and current medications will be reviewed. A series of tests will also be performed to see if they are good to be selected for the study. If the participant meets all required criteria and are interested in continuing, the participant will be brought into the study clinic to stay overnight for 6 days. On day 6, the participant will be discharged. About 28 to 35 days after discharge, the participant will be contacted for a follow up visit either in person or by telephone. This is to check up on how the participant is doing and to conclude the study.

Conditions

• Liver Diseases
• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	PF-07923568	One time dose of 4 capsules taken orally.

Timeline

• Start date: 2023-06-07
• Primary completion: 2024-02-07
• Completion: 2024-02-07
• First posted: 2023-05-12
• Last updated: 2025-03-21
• Results posted: 2025-03-21

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study