A Study to Learn About How Loss of Liver Function Affects the Blood Levels of the Study Medicine Called PF-07817883.

A PHASE 1, OPEN-LABEL, SINGLE-DOSE, PARALLEL GROUP STUDY TO ASSESS PHARMACOKINETICS, SAFETY AND TOLERABILITY OF PF-07817883 IN ADULT PARTICIPANTS WITH VARYING DEGREES OF HEPATIC IMPAIRMENT RELATIVE TO PARTICIPANTS WITHOUT HEPATIC IMPAIRMENT

The purpose of the study is to learn about the safety of PF-07817883 and how PF-07817883 is processed in the body of adult participants. These participants will have different degrees of loss of liver function. Participants with mild, moderate, severe or no loss of liver function will be enrolled in 4 groups.

This study is seeking participants who:

• are male or female of 18- 75 years of age
• either have different amounts of damage to liver function or for one of the groups, no damage
• willing to follow the requirements of the study including stay at clinic for 6 nights and 7 days

About, 6-8 participants will be enrolled in group 1 (participants without loss of liver function) and group 3 (participants with moderate loss of liver function). In group 4 (participants with severe loss of function), around 4 to 8 participants will be enrolled. Participants in group 2 (mild loss of function) will only be enrolled after review of the data from groups 3 and 4.

If participants consent to participate in the study, it may take up to 4 weeks to complete all the tests to confirm if they are eligible to participate in the study. If they seem to be eligible for the study, participants will be admitted to a clinic research unit (CRU) at least 12 hours before dosing. On Day 1, participants will receive a single dose of study medicine (Day 1). A series of blood samples will be collected before and after dosing. Participants will be discharged from the CRU on Day 6. A follow-up phone call (on CRU visit, if needed), will occur 28-35 days after dosing.

The whole study will last for a minimum of 5 weeks and a maximum of 10 weeks.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Drug: PF-07817883

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92801
      • Anaheim Clinical Trials, LLC
    • Garden Grove, California, United States, 92844
      • National Institute of Clinical Research
    • Montclair, California, United States, 91763
      • Catalina Research Institute, LLC
  • Florida
    • Hollywood, Florida, United States, 33024
      • Research Centers of America
    • Hollywood, Florida, United States, 33024
      • Research Centers of America ( Hollywood )
    • Tampa, Florida, United States, 33603
      • Genesis Clinical Research, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• (HI Cohorts Only): Stable HI that meets criteria for Class A or B of the Child-Pugh classification;
• (all Cohorts): BMI of 17.5 to 38.0 kg/m2

Exclusion Criteria:

• Any condition possibly affecting drug absorption Additional Exclusion Criteria for HI Cohorts Only
• Limited predicted life expectancy
• Hepatic dysfunction secondary to acute ongoing hepatocellular process.
• Signs of clinically active Grade 2, 3 or 4 hepatic encephalopathy.
• Severe ascites and/or pleural effusion
• History of kidney, liver, or heart transplantation.
• Persistent severe, uncontrolled hypertension.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; No hepatic impairment	Drug: PF-07817883; Experimental
Experimental: Cohort 2; Mild hepatic impairment	Drug: PF-07817883; Experimental
Experimental: Cohort 3; Moderate hepatic impairment	Drug: PF-07817883; Experimental
Experimental: Cohort 4; Severe hepatic impairment	Drug: PF-07817883; Experimental

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Observed Plasma Concentration (Cmax) of PF-07817883	Plasma PF-07817883 PK parameters	Day 1 to Day 6
Area Under the Plasma Concentration-time Profile from Time Zero to Extrapolated Infinite Time (AUCinf)	Plasma PF-07817883 PK parameter	Day 1 to Day 6
Area Under the Plasma Concentration-time Profile from Time Zero to the Time of the Last Quantifiable Concentration (AUClast)	(Optional) Plasma PF-07817883 parameter	Day 1 to Day 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Non-Serious Adverse Events	Safety Parameters	Screening to Day 35
Number of Participants with Treatment Emergent Adverse Events	Safety Parameters	Day 1 to Day 35
Number of Participants with Clinically Significant ECG Abnormalities	ECG parameters include QTcF, QRS, RR interval, PR interval, and Heart Rate	Day 1 to Day 6
Number of Participants with Clinically Significant Abnormal Vital Signs	Vital Signs parameters include diastolic blood pressure, systolic blood pressure, and pulse rate	Day 1 to Day 6
Number of Participants with Clinically Significant Abnormal Laboratory Values	Blood hematology and Chemistry and Urinalysis	Baseline to Day 6
Number of Participants with Serious Adverse Events	Safety Parameters	Screening to Day 35

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2023
• Primary Completion (Actual): June 27, 2024
• Study Completion (Actual): June 27, 2024

Study Registration Dates

• First Submitted: May 23, 2023
• First Submitted That Met QC Criteria: May 23, 2023
• First Posted (Actual): June 1, 2023

Study Record Updates

• Last Update Posted (Actual): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 16, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: COVID-19; Hepatic Impairment
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: C5091014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No