Phase 1 Study of GSK3228836 Pharmacokinetics in Participants With Hepatic Impairment

NCT04971928 | Completed Phase 1 FDA Drug

• 1 other identifier: 205871
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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.

Conditions

Hepatitis B

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• 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

Study Arms (3)

Participants with Moderate (CP-B) hepatic impairment

EXPERIMENTAL

Drug: GSK3228836

Participants with Mild (CP-A) hepatic impairment

EXPERIMENTAL

Drug: GSK3228836

Healthy participants

EXPERIMENTAL

Drug: GSK3228836

Interventions

GSK3228836 DRUG

GSK3228836 will be administered

Healthy participants; Participants with Mild (CP-A) hepatic impairment; Participants with Moderate (CP-B) hepatic impairment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (2)

GSK Investigational Site

Orlando, Florida, 32809, United States

Location

GSK Investigational Site

San Antonio, Texas, 78215, United States

Location

MeSH Terms

Conditions

Hepatitis B; Fibrosis

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2021
• First Posted: July 22, 2021
• Study Start: September 7, 2021
• Primary Completion: May 12, 2022
• Study Completion: May 12, 2022
• Last Updated: September 27, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.
• 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.

Locations

US (2)