Phase 1 Study of GSK3228836 Pharmacokinetics in Participants With Hepatic Impairment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-07

Study Completion Date

2022-05-12

Brief Summary

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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.

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Detailed Description

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Conditions

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Hepatitis B

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Participants with Moderate (CP-B) hepatic impairment

Group Type EXPERIMENTAL

GSK3228836

Intervention Type DRUG

GSK3228836 will be administered

Participants with Mild (CP-A) hepatic impairment

Group Type EXPERIMENTAL

GSK3228836

Intervention Type DRUG

GSK3228836 will be administered

Healthy participants

Group Type EXPERIMENTAL

GSK3228836

Intervention Type DRUG

GSK3228836 will be administered

Interventions

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GSK3228836

GSK3228836 will be administered

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes