A Study to Learn About How Loss of Liver Function Affects the Blood Levels of the Study Medicine Called PF-07817883.
- Registration Number
- NCT05884554
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
- (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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 1 PF-07817883 No hepatic impairment Cohort 2 PF-07817883 Mild hepatic impairment Cohort 3 PF-07817883 Moderate hepatic impairment Cohort 4 PF-07817883 Severe hepatic impairment
- Primary Outcome Measures
Name Time Method Maximum Observed Plasma Concentration (Cmax) of PF-07817883 Day 1 to Day 6 Plasma PF-07817883 PK parameters
Area Under the Plasma Concentration-time Profile from Time Zero to Extrapolated Infinite Time (AUCinf) Day 1 to Day 6 Plasma PF-07817883 PK parameter
Area Under the Plasma Concentration-time Profile from Time Zero to the Time of the Last Quantifiable Concentration (AUClast) Day 1 to Day 6 (Optional) Plasma PF-07817883 parameter
- Secondary Outcome Measures
Name Time Method Number of Participants with Non-Serious Adverse Events Screening to Day 35 Safety Parameters
Number of Participants with Treatment Emergent Adverse Events Day 1 to Day 35 Safety Parameters
Number of Participants with Clinically Significant ECG Abnormalities Day 1 to Day 6 ECG parameters include QTcF, QRS, RR interval, PR interval, and Heart Rate
Number of Participants with Clinically Significant Abnormal Vital Signs Day 1 to Day 6 Vital Signs parameters include diastolic blood pressure, systolic blood pressure, and pulse rate
Number of Participants with Clinically Significant Abnormal Laboratory Values Baseline to Day 6 Blood hematology and Chemistry and Urinalysis
Number of Participants with Serious Adverse Events Screening to Day 35 Safety Parameters
Trial Locations
- Locations (6)
Anaheim Clinical Trials, LLC
🇺🇸Anaheim, California, United States
Research Centers of America ( Hollywood )
🇺🇸Hollywood, Florida, United States
Research Centers of America
🇺🇸Hollywood, Florida, United States
Genesis Clinical Research, LLC
🇺🇸Tampa, Florida, United States
Catalina Research Institute, LLC
🇺🇸Montclair, California, United States
National Institute of Clinical Research
🇺🇸Garden Grove, California, United States