Last updated: 09/24/2024 06:10:58

Phase 1 study of GSK3228836 pharmacokinetics in participants with hepatic impairment

GSK study ID
205871
See study documents
Clinicaltrials.gov ID
NCT04971928
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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)
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

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

Maximum observed concentration (Cmax)

Timeframe: Up to Day 50 post-dose

Secondary outcomes:

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

Timeframe: Up to 24 hours post-dose

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

Timeframe: Up to 168 hours post-dose

Plasma concentration of GSK3228836 on Day 8

Timeframe: Day 8 post-dose

Apparent terminal phase half-life (t1/2)

Timeframe: Up to Day 50 post-dose

Apparent clearance (CL/F)

Timeframe: Up to Day 50 post-dose

Time of occurrence of Cmax (Tmax)

Timeframe: Up to Day 50 post-dose

Apparent terminal phase volume of distribution (Vz/F)

Timeframe: Up to Day 50 post-dose

Interventions:
  • Drug: GSK3228836
    • Enrollment:
    24
    Primary completion date:
    2022-12-05
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Nadia Noormohamed, Tamara Lukic, Thomas C Marbury, Eric J Lawitz, Holly Prescott, Mindy Magee, Ahmed Nader, Kelong Han. A Phase 1, Single-Dose Study to Evaluate the Pharmacokinetics and Safety of Bepirovirsen in Adults with Hepatic Impairment and Healthy Participants (B-Assured). Clinical pharmacology in drug development. 2024-Sep-13; doi:10.1002/cpdd.1454 http://dx.doi.org/10.1002/cpdd.1454 PMID: 39268699 DOI: 10.1002/cpdd.1454
    Medical condition
    Hepatitis B
    Product
    Not applicable
    Collaborators
    Not applicable
    Study date(s)
    September 2021 to May 2022
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    Yes
    • 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.
    • 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).
    Inclusion and exclusion 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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Orlando, Florida, United States, 32809
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    San Antonio, Texas, United States, 78215
    Status
    Study Complete
    Contact us

    Study documents

    Protocol
    Available language(s): English
    Download document(s)
    Statistical analysis plan
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Study Results yet to be posted

    Recruitment status
    Study complete
    Actual primary completion date
    2022-12-05
    Actual study completion date
    2022-12-05

    Plain language summaries

    Summary of results in plain language
    Available language(s): English
    Download document(s)

    To view plain language summaries on trialsummaries.com click here.

    Additional information about the trial

    Additional information
    Not applicable
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