Phase 1 Study of GSK3228836 Pharmacokinetics in Participants With Hepatic Impairment

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04971928

Collaborator

(none)

Enrollment

Locations

Arms

14.1

Anticipated Duration (Months)

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis B	Drug: GSK3228836	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

48 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase 1, Open-label, Single-Dose Study to Evaluate the Pharmacokinetics of GSK3228836 in Adults With Hepatic Impairment and Healthy Matched Control Participants (B-Assured)

Actual Study Start Date :

Sep 7, 2021

Anticipated Primary Completion Date :

Nov 10, 2022

Anticipated Study Completion Date :

Nov 10, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Participants with Moderate (CP-B) hepatic impairment	Drug: GSK3228836 GSK3228836 will be administered
Experimental: Participants with Mild (CP-A) hepatic impairment	Drug: GSK3228836 GSK3228836 will be administered
Experimental: Healthy participants	Drug: GSK3228836 GSK3228836 will be administered

Arm

Intervention/Treatment

Experimental: Participants with Moderate (CP-B) hepatic impairment

Drug: GSK3228836

GSK3228836 will be administered

Experimental: Participants with Mild (CP-A) hepatic impairment

Drug: GSK3228836

GSK3228836 will be administered

Experimental: Healthy participants

Drug: GSK3228836

GSK3228836 will be administered

Outcome Measures

Primary Outcome Measures

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

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 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.