Clinical trial NCT05884554: A Study to Learn About How Loss of Liver Function Affects the Blood Levels of the Study Medicine Called PF-07817883.
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: COVID-19
Keywords: Hepatic Impairment
COVID-19
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2023-06-01
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of PF-07817883
timeFrame: Day 1 to Day 6
measure: Area Under the Plasma Concentration-time Profile from Time Zero to Extrapolated Infinite Time (AUCinf)
timeFrame: Day 1 to Day 6
measure: Area Under the Plasma Concentration-time Profile from Time Zero to the Time of the Last Quantifiable Concentration (AUClast)
timeFrame: Day 1 to Day 6
Secondary outcomes:
measure: Number of Participants with Non-Serious Adverse Events
timeFrame: Screening to Day 35
measure: Number of Participants with Treatment Emergent Adverse Events
timeFrame: Day 1 to Day 35
measure: Number of Participants with Clinically Significant ECG Abnormalities
timeFrame: Day 1 to Day 6
measure: Number of Participants with Clinically Significant Abnormal Vital Signs
timeFrame: Day 1 to Day 6
measure: Number of Participants with Clinically Significant Abnormal Laboratory Values
timeFrame: Baseline to Day 6
measure: Number of Participants with Serious Adverse Events
timeFrame: Screening to Day 35
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Anaheim Clinical Trials, LLC
state: California
city: Garden Grove
country: United States
facility: National Institute of Clinical Research
state: California
city: Montclair
country: United States
facility: Catalina Research Institute, LLC
state: California
city: Hollywood
country: United States
facility: Research Centers of America ( Hollywood )
state: Florida
city: Hollywood
country: United States
facility: Research Centers of America
state: Florida
city: Tampa
country: United States
facility: Genesis Clinical Research, LLC
state: Florida
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: