Phase 1 Study of GSK3228836 Pharmacokinetics in Participants With Hepatic Impairment

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 1

Conditions

Hepatitis B

Treatments

Drug: GSK3228836

Study type

Interventional

Funder types

Industry

Identifiers

NCT04971928

205871

Details and patient eligibility

About

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.

Enrollment

24 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.