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.
Liver Diseases, Hepatic Impairment
About this trial
This is an interventional basic science trial for Liver Diseases focused on measuring healthy volunteers
Eligibility Criteria
Inclusion Criteria: for healthy volunteers: 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. --Exclusion criteria for all participants: 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 Exclusion criteria for non-healthy participants who have hepatic impairment: 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
Sites / Locations
- Orange County Research CenterRecruiting
- Orlando Clinical Research CenterRecruiting
- Genesis Clinical Research, LLCRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Healthy subjects
Mild Hepatic impaired subjects
Moderate hepatic impaired subjects
Severe Hepatic Impaired Subjects
One time dose of 4 capsules taken orally.
One time dose of 4 capsules taken orally.
One time dose of 4 capsules taken orally
One time dose of 4 capsules taken orally.