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Phase 1 Study of GSK3228836 Pharmacokinetics in Participants With Hepatic Impairment

Primary Purpose

Hepatitis B

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

GSK3228836

About this trial

This is an interventional treatment trial for Hepatitis B focused on measuring GSK3228836, Hepatitis B, Child-Pugh B (CP-B) cirrhosis, Child-Pugh A (CP-A) cirrhosis, Pharmacokinetics, B-Assured

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

GSK Investigational Site
GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Participants with Moderate (CP-B) hepatic impairment

Participants with Mild (CP-A) hepatic impairment

Healthy participants

Arm Description

Outcomes

Primary Outcome Measures

Area under the concentration-time curve (AUC) from time zero (pre-dose) extrapolated to infinite time [AUC(0-infinity)]

Maximum observed concentration (Cmax)

Secondary Outcome Measures

AUC from time zero (pre-dose) to 24 hours [AUC(0-24)]

AUC from time zero (pre-dose) to 168 hours [AUC(0-168)]

Plasma concentration of GSK3228836 on Day 8

Apparent terminal phase half-life (t1/2)

Apparent clearance (CL/F)

Time of occurrence of Cmax (Tmax)

Apparent terminal phase volume of distribution (Vz/F)

Full Information

NCT ID

NCT04971928

First Posted

June 22, 2021

Last Updated

September 26, 2022

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT04971928

Brief Title

Phase 1 Study of GSK3228836 Pharmacokinetics in Participants With Hepatic Impairment

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)

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Completed

Study Start Date

September 7, 2021 (Actual)

Primary Completion Date

May 12, 2022 (Actual)

Study Completion Date

May 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis B

Keywords

GSK3228836, Hepatitis B, Child-Pugh B (CP-B) cirrhosis, Child-Pugh A (CP-A) cirrhosis, Pharmacokinetics, B-Assured

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Participants with Moderate (CP-B) hepatic impairment

Arm Type

Experimental

Arm Title

Participants with Mild (CP-A) hepatic impairment

Arm Type

Experimental

Arm Title

Healthy participants

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

GSK3228836

Intervention Description

GSK3228836 will be administered

Primary Outcome Measure Information:

Title

Area under the concentration-time curve (AUC) from time zero (pre-dose) extrapolated to infinite time [AUC(0-infinity)]

Time Frame

Up to Day 50 post-dose

Title

Maximum observed concentration (Cmax)

Time Frame

Up to Day 50 post-dose

Secondary Outcome Measure Information:

Title

AUC from time zero (pre-dose) to 24 hours [AUC(0-24)]

Time Frame

Up to 24 hours post-dose

Title

AUC from time zero (pre-dose) to 168 hours [AUC(0-168)]

Time Frame

Up to 168 hours post-dose

Title

Plasma concentration of GSK3228836 on Day 8

Time Frame

Day 8 post-dose

Title

Apparent terminal phase half-life (t1/2)

Time Frame

Up to Day 50 post-dose

Title

Apparent clearance (CL/F)

Time Frame

Up to Day 50 post-dose

Title

Time of occurrence of Cmax (Tmax)

Time Frame

Up to Day 50 post-dose

Title

Apparent terminal phase volume of distribution (Vz/F)

Time Frame

Up to Day 50 post-dose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Orlando

State/Province

Florida

ZIP/Postal Code

32809

Country

United States

Facility Name

GSK Investigational Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78215

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

IPD for this study will be made available via the Clinical Study Data Request site.

IPD Sharing Time Frame

IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.

IPD Sharing Access Criteria

Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

IPD Sharing URL

http://clinicalstudydatarequest.com

Learn more about this trial

Phase 1 Study of GSK3228836 Pharmacokinetics in Participants With Hepatic Impairment

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