Clinical trial NCT04971928: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatitis B
Keywords: GSK3228836
Hepatitis B
Child-Pugh B (CP-B) cirrhosis
Child-Pugh A (CP-A) cirrhosis
Pharmacokinetics
B-Assured
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2021-07-22
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Area under the concentration-time curve (AUC) from time zero (pre-dose) extrapolated to infinite time [AUC(0-infinity)]
timeFrame: Up to Day 50 post-dose
measure: Maximum observed concentration (Cmax)
timeFrame: Up to Day 50 post-dose
Secondary outcomes:
measure: AUC from time zero (pre-dose) to 24 hours [AUC(0-24)]
timeFrame: Up to 24 hours post-dose
measure: AUC from time zero (pre-dose) to 168 hours [AUC(0-168)]
timeFrame: Up to 168 hours post-dose
measure: Plasma concentration of GSK3228836 on Day 8
timeFrame: Day 8 post-dose
measure: Apparent terminal phase half-life (t1/2)
timeFrame: Up to Day 50 post-dose
measure: Apparent clearance (CL/F)
timeFrame: Up to Day 50 post-dose
measure: Time of occurrence of Cmax (Tmax)
timeFrame: Up to Day 50 post-dose
measure: Apparent terminal phase volume of distribution (Vz/F)
timeFrame: Up to Day 50 post-dose
Other outcomes:
Locations:
city: Orlando
country: United States
facility: GSK Investigational Site
state: Florida
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: