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.

NCT05857644 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: C5241012NCT05857644
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 3

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.

Conditions

Liver Diseases; Hepatic Impairment

Keywords

healthy volunteers

Outcome Measures

Primary Outcomes (3)

• Plasma Maximum Concentration (Cmax) of Sisunatovir Following Administration of a Single Oral Dose

  Cmax was the highest concentration observed directly from data

  Hours 0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, and 120 postdose from Day 1 to Day 6

• 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

  AUClast was determined using linear/Log trapezoidal method

  Hours 0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, and 120 postdose from Day 1 to Day 6

• Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Sisunatovir Following Administration of a Single Oral Dose

  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.

  Hours 0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, and 120 postdose from Day 1 to Day 6

Secondary Outcomes (4)

• 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

• Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria

  Day -1, Day 1, Day 2, and Day 6

Study Arms (4)

Healthy subjects

EXPERIMENTAL

One time dose of 4 capsules taken orally.

Drug: PF-07923568

Mild Hepatic impaired subjects

EXPERIMENTAL

One time dose of 4 capsules taken orally.

Drug: PF-07923568

Moderate hepatic impaired subjects

EXPERIMENTAL

One time dose of 4 capsules taken orally

Drug: PF-07923568

Severe Hepatic Impaired Subjects

EXPERIMENTAL

One time dose of 4 capsules taken orally.

Drug: PF-07923568

Interventions

PF-07923568 DRUG

One time dose of 4 capsules taken orally.

Also known as: Sisunatovir

Healthy subjects; Mild Hepatic impaired subjects; Moderate hepatic impaired subjects; Severe Hepatic Impaired Subjects

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (3)

Orange County Research Center

Tustin, California, 92780, United States

Location

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

Genesis Clinical Research, LLC

Tampa, Florida, 33603, United States

Location

Related Links

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

MeSH Terms

Conditions

Liver Diseases

Interventions

sisunatovir

Condition Hierarchy (Ancestors)

Digestive System Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: May 12, 2023
• Study Start: June 7, 2023
• Primary Completion: February 7, 2024
• Study Completion: February 7, 2024
• Last Updated: March 21, 2025
• Results First Posted: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)