This is a Phase 1, open-label, parallel-group study to evaluate the pharmacokinetics of GSK3228836 in participants with Child-Pugh B (CP-B) cirrhosis (moderate hepatic impairment), Child-Pugh A (CP-A) cirrhosis (mild hepatic impairment) and participants with normal hepatic function as healthy control.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
GSK3228836 will be administered
GSK Investigational Site
Orlando, Florida, United States
GSK Investigational Site
San Antonio, Texas, United States
Area under the concentration-time curve (AUC) from time zero (pre-dose) extrapolated to infinite time [AUC(0-infinity)]
Time frame: Up to Day 50 post-dose
Maximum observed concentration (Cmax)
Time frame: Up to Day 50 post-dose
AUC from time zero (pre-dose) to 24 hours [AUC(0-24)]
Time frame: Up to 24 hours post-dose
AUC from time zero (pre-dose) to 168 hours [AUC(0-168)]
Time frame: Up to 168 hours post-dose
Plasma concentration of GSK3228836 on Day 8
Time frame: Day 8 post-dose
Apparent terminal phase half-life (t1/2)
Time frame: Up to Day 50 post-dose
Apparent clearance (CL/F)
Time frame: Up to Day 50 post-dose
Time of occurrence of Cmax (Tmax)
Time frame: Up to Day 50 post-dose
Apparent terminal phase volume of distribution (Vz/F)
Time frame: Up to Day 50 post-dose
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