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

NCT05884554 | Completed Phase 1 FDA Drug

• 1 other identifier: C5091014
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

COVID-19

Keywords

Hepatic Impairment; COVID-19

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Number of Participants with Non-Serious Adverse Events

  Screening to Day 35

• Number of Participants with Treatment Emergent Adverse Events

  Day 1 to Day 35

• Number of Participants with Clinically Significant ECG Abnormalities

  Day 1 to Day 6

• Number of Participants with Clinically Significant Abnormal Vital Signs

  Day 1 to Day 6

• Number of Participants with Clinically Significant Abnormal Laboratory Values

  Baseline to Day 6

Study Arms (4)

Cohort 1

EXPERIMENTAL

No hepatic impairment

Drug: PF-07817883

Cohort 2

EXPERIMENTAL

Mild hepatic impairment

Drug: PF-07817883

Cohort 3

EXPERIMENTAL

Moderate hepatic impairment

Drug: PF-07817883

Cohort 4

EXPERIMENTAL

Severe hepatic impairment

Drug: PF-07817883

Interventions

PF-07817883 DRUG

Experimental

Cohort 1; Cohort 2; Cohort 3; Cohort 4

Eligibility Criteria

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

You may qualify if:

• (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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (6)

Anaheim Clinical Trials, LLC

Anaheim, California, 92801, United States

Location

National Institute of Clinical Research

Garden Grove, California, 92844, United States

Location

Catalina Research Institute, LLC

Montclair, California, 91763, United States

Location

Research Centers of America ( Hollywood )

Hollywood, Florida, 33024, United States

Location

Research Centers of America

Hollywood, Florida, 33024, 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

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: May 23, 2023
• First Posted: June 1, 2023
• Study Start: June 15, 2023
• Primary Completion: June 27, 2024
• Study Completion: June 27, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)