This study is designed to study the pharmacokinetic (PK) and safety profiles of a single dose of efimosfermin alfa in participants with varying degrees of Hepatic Impairment (HI) (assessed by Child-Pugh score) due to steatotic liver disease, with and without significant alcohol consumption.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Efimosfermin alfa to be administrated subcutaneously
Area under the serum drug concentration versus time curve from time zero to infinity (AUC[0-inf]) of efimosfermin alfa
Time frame: Up to 90 Days
Maximum observed serum drug concentration (Cmax) of efimosfermin alfa
Time frame: Up to 90 Days
Number of participants with Adverse Events (AEs), treatment related AEs and serious adverse events (SAEs)
Time frame: Up to 90 Days
Number of participants with Clinically significant changes in hematology, chemistry, and urinalysis parameters
Time frame: Up to 90 Days
Number of participants with Clinically significant changes in Vital signs and 12-lead electrocardiogram (ECG) findings
Time frame: Up to 90 Days
Area under the serum drug concentration versus time curve from time zero to the time of the last quantifiable concentration (AUC[0-t]) of efimosfermin alfa
Time frame: Up to 90 Days
Time to maximum observed serum drug concentration (Tmax) of efimosfermin alfa
Time frame: Up to 90 Days
Apparent terminal phase half-life (t1/2) of efimosfermin alfa
Time frame: Up to 90 Days
Time prior to the first measurable (non-zero) serum concentration (Tlag) of efimosfermin alfa
Time frame: Up to 90 Days
Apparent clearance (CL/F) of efimosfermin alfa
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Time frame: Up to 90 days
Apparent terminal phase volume of distribution (Vz/F) of efimosfermin alfa
Time frame: Up to 90 days
Terminal elimination rate constant (Lambda z) of efimosfermin alfa
Time frame: Up to 90 days