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.

Sponsor

Pfizer (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05857644

Collaborator

(none)

Enrollment

Arms

6.8

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Liver Diseases Hepatic Impairment	Drug: PF-07923568	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

28 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

An open-label, single dose, parallel group, multicenter study to investigate the effect of varying degrees of hepatic function on the plasma PK of PF-07923568 after a single, oral 200 mg dose administered in the fed state (standard breakfast).An open-label, single dose, parallel group, multicenter study to investigate the effect of varying degrees of hepatic function on the plasma PK of PF-07923568 after a single, oral 200 mg dose administered in the fed state (standard breakfast).

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Anticipated Study Start Date :

May 23, 2023

Anticipated Primary Completion Date :

Dec 15, 2023

Anticipated Study Completion Date :

Dec 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Healthy subjects One time dose of 4 capsules taken orally.	Drug: PF-07923568 One time dose of 4 capsules taken orally. Other Names: Sisunatovir
Experimental: Mild Hepatic impaired subjects One time dose of 4 capsules taken orally.	Drug: PF-07923568 One time dose of 4 capsules taken orally. Other Names: Sisunatovir
Experimental: Moderate hepatic impaired subjects One time dose of 4 capsules taken orally	Drug: PF-07923568 One time dose of 4 capsules taken orally. Other Names: Sisunatovir
Experimental: Severe Hepatic Impaired Subjects One time dose of 4 capsules taken orally.	Drug: PF-07923568 One time dose of 4 capsules taken orally. Other Names: Sisunatovir

Outcome Measures

Primary Outcome Measures

Plasma concentrations of PF-07923568 will be listed and descriptively summarized by nominal PK sampling time and treatment. [6 days]

Secondary Outcome Measures

Assessment of Treatment emergent adverse events [6 weeks]
Number of participants with abnormal laboratory test results [6 weeks]
Number of participants with abnormal electrocardiogram (ECG) readings [6 weeks]
Number of participants with abnormal Vital Signs [6 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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, including BP and pulse rate measurement, standard 12-lead ECG and clinical laboratory tests.
body weight within +/-15 kg of the average of pooled hepatic impaired group and +/- 10 years of the average pooled hepatic impairment group.

--Exclusion criteria for all participants:

Any condition or surgery possibly affecting drug absorption (eg, prior bariatric surgery, gastrectomy, ileal resection)
Positive HIV antibodies
Positive drug or alcohol test eGFR <60 mL/min/1.73m2 at screening

Exclusion criteria for non-healthy participants who have hepatic impairment:

Stable concomitant meds and hepatic impairment with no change in the last 28 days
Hepatic carcinoma or hepatorenal syndrome or limited predicted life expectancy (defined as <1 year).
A diagnosis of hepatic dysfunction secondary to any acute ongoing hepatocellular process that is documented by medical history, PE, liver biopsy, hepatic ultrasound, CT scan, or MRI.
History of gastrointestinal hemorrhage due to esophageal varices or peptic ulcers less than 4 weeks prior to screening.

--Severe ascites and/or pleural effusion, except for those categorized as severe hepatic impairment who may be enrolled provided participant is medically stable, per the investigators' medical judgment.

Previously received a kidney, liver, or heart transplant. ALT/AST greater than 5X upper limit normal

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

To obtain contact information for a study center near you, click here.

Publications

None provided.

Responsible Party:

Pfizer

ClinicalTrials.gov Identifier:

NCT05857644

Other Study ID Numbers:

C5241012

First Posted:

May 12, 2023

Last Update Posted:

May 12, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Pfizer

healthy volunteers

Additional relevant MeSH terms:

Liver Diseases

Study Results

No Results Posted as of May 12, 2023