Phase 1 Study of GSK3228836 Pharmacokinetics in Participants With Hepatic Impairment

Phase 1

Completed

• Conditions: Hepatitis B
• Interventions: Drug: GSK3228836

• Registration Number: NCT04971928
• Lead Sponsor: GlaxoSmithKline

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-22
• Study First Submitted QC: 2021-07-12
• Study First Posted: 2021-07-22
• Study Start: 2021-09-07
• Primary Completion: 2022-05-12
• Study Completion: 2022-05-12
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-26
• Last Update Posted: 2022-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Participants with Moderate (CP-B) hepatic impairment	GSK3228836	-
Participants with Mild (CP-A) hepatic impairment	GSK3228836	-
Healthy participants	GSK3228836	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
AUC from time zero (pre-dose) to 24 hours [AUC(0-24)]	Up to 24 hours post-dose
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 clearance (CL/F)	Up to Day 50 post-dose
Time of occurrence of Cmax (Tmax)	Up to Day 50 post-dose
Apparent terminal phase half-life (t1/2)	Up to Day 50 post-dose
Apparent terminal phase volume of distribution (Vz/F)	Up to Day 50 post-dose

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 San Antonio, Texas, United States