Hepatitis B
Conditions
Keywords
GSK3228836, Hepatitis B, Child-Pugh B (CP-B) cirrhosis, Child-Pugh A (CP-A) cirrhosis, Pharmacokinetics, B-Assured
Brief summary
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.
Interventions
DRUGGSK3228836
GSK3228836 will be administered
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Body weight \>50 Kilogram (kg) and body mass index (BMI) within the range 19 to 40 Kilogram per square meters (kg/m2) (inclusive) * Capable of giving signed informed consent. * Child-Pugh B cirrhosis (moderate hepatic impairment; Part 1) or Child-Pugh A cirrhosis (mild hepatic impairment; Part 2) or a healthy control participant based on a medical evaluation including medical history, physical examination (PE), laboratory tests.
Exclusion criteria
* Diagnosed or suspected hepatocellular carcinoma. * History of malignancy within the past 5 years except for cancers that are cured by surgical resection (e.g., skin cancer). * History of vasculitis or presence of symptoms and signs of potential vasculitis or history/presence of other diseases that may be associated with vasculitis condition. * Unstable cardiac function or high blood pressure that is not controlled (based on the investigator's discretion). * Any other medical condition which, in the judgment of the investigator and Medical Monitor, could jeopardize the integrity of the data derived from that participant or the safety of the participant. * Participants who have taken or are currently taking any therapies not allowed by the protocol. * A positive test for human immunodeficiency virus (HIV) antibody. * History of sensitivity to GSK3228836 or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the concentration-time curve (AUC) from time zero (pre-dose) extrapolated to infinite time [AUC(0-infinity)] | Up to Day 50 post-dose |
| Maximum observed concentration (Cmax) | Up to Day 50 post-dose |
Secondary
| Measure | Time frame |
|---|---|
| AUC from time zero (pre-dose) to 168 hours [AUC(0-168)] | Up to 168 hours post-dose |
| Plasma concentration of GSK3228836 on Day 8 | Day 8 post-dose |
| Apparent terminal phase half-life (t1/2) | Up to Day 50 post-dose |
| Apparent clearance (CL/F) | Up to Day 50 post-dose |
| Time of occurrence of Cmax (Tmax) | Up to Day 50 post-dose |
| Apparent terminal phase volume of distribution (Vz/F) | Up to Day 50 post-dose |
| AUC from time zero (pre-dose) to 24 hours [AUC(0-24)] | Up to 24 hours post-dose |
Countries
United States
Outcome results
None listed