Phase 1 Study of GSK3228836 Pharmacokinetics in Participants With Hepatic Impairment

Hepatitis B Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04971928
• Other study ID #: 205871
• Status: Completed
• Phase: Phase 1
• Start date: September 7, 2021
• Est. completion date: May 12, 2022

Study information

• Verified date: September 2022
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 12, 2022
• Est. primary completion date: May 12, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis B

Intervention

Drug:
• GSK3228836
GSK3228836 will be administered

Locations

Country	Name	City	State
United States	GSK Investigational Site	Orlando	Florida
United States	GSK Investigational Site	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Maximum observed concentration (Cmax)		Up to Day 50 post-dose
Secondary	AUC from time zero (pre-dose) to 24 hours [AUC(0-24)]		Up to 24 hours post-dose
Secondary	AUC from time zero (pre-dose) to 168 hours [AUC(0-168)]		Up to 168 hours post-dose
Secondary	Plasma concentration of GSK3228836 on Day 8		Day 8 post-dose
Secondary	Apparent terminal phase half-life (t1/2)		Up to Day 50 post-dose
Secondary	Apparent clearance (CL/F)		Up to Day 50 post-dose
Secondary	Time of occurrence of Cmax (Tmax)		Up to Day 50 post-dose
Secondary	Apparent terminal phase volume of distribution (Vz/F)		Up to Day 50 post-dose