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
GSK Investigational Site
Rialto, California, United States
RECRUITINGGSK Investigational Site
Tampa, Florida, United States
RECRUITINGGSK Investigational Site
San Antonio, Texas, United States
RECRUITINGArea 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