Evaluating the effect of bepirovirsen on heart function in healthy volunteers

A Phase 1, Randomized, Double-Blinded, Placebo-Controlled, Parallel Group Study to Evaluate the Effect of Bepirovirsen on Cardiac Conduction as Assessed by 12-lead Electrocardiogram in Healthy Volunteers

This study tests how a single dose of bepirovirsen affects heart function in healthy adults to see if it changes the heart's electrical activity compared to a placebo.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: GlaxoSmithKline (industry)
• Locations: 1 site (Austin, Texas)
• Trial ID: NCT06422767 on ClinicalTrials.gov

What this trial studies

This study evaluates how a single dose of bepirovirsen affects cardiac conduction, specifically the QT interval, in healthy volunteers compared to a placebo. Participants will undergo medical evaluations, including ECGs, to assess their health status before receiving the treatment. The study aims to model the relationship between the concentration of bepirovirsen in the body and its effect on the QT interval, which is crucial for understanding potential cardiac risks. The trial is designed for individuals aged 18 to 55 who meet specific health criteria.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 18 to 55 with a body weight of at least 50 kg and a BMI between 19 and 32.

Not a fit: Patients with existing cardiovascular or other significant health disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into the cardiac safety profile of bepirovirsen for future use in treating hepatitis B.

How similar studies have performed: Other studies evaluating cardiac effects of antiviral medications have shown varying degrees of success, but this specific approach with bepirovirsen is novel.

Eligibility criteria

Inclusion Criteria:

* Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
* Participants who are overtly healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests, electrocardiogram (ECG) and vital signs.
* Body weight greater than equal to (\>=) 50 Kilograms (kg) and Body mass index (BMI) within the range 19-32 Kilograms per square meter (kg/m\^2) (inclusive).
* Study will enroll both male and female participants.

  o Female participants are eligible to participate if they are not pregnant or breastfeeding and are either not of childbearing potential or agree to using a highly effective method of contraception.
* Capable of giving signed informed consent.

Exclusion Criteria:

* History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data.
* History of vasculitis or presence of symptoms and signs of potential vasculitis
* History of lymphoma, leukemia, or any malignancy except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for at least 3 years.
* Participants with any other medical conditions which, in the judgement of the investigator and/or Medical Monitor, could jeopardize the integrity of the data derived from that participant or the safety of the participant.
* Past, current or intended use of over-the-counter or prescription medication, including herbal medications within 7 days or 5 half-lives (whichever is longer) before dosing.
* Current or recent use of creatine-containing supplements, or intended use up to 50 days post-dosing.
* Prior treatment with any oligonucleotide or small interfering Ribonucleic acid (RNA) (siRNA) within 12 months before dosing.
* Exposure to more than 4 new chemical entities within 12 months before the first dosing day
* Current enrollment or past participation in another investigational study in which an investigational intervention (e.g., drug, vaccine, invasive device) was administered within 5 half-lives (if known) or twice the duration of biological effect (if known), whichever is longer, or within the last 90 days (if half-life and duration of biological effect are unknown), before signing of consent in any other clinical study involving an investigational study intervention or any other type of medical research.
* Current enrollment or past participation in this clinical study.
* Positive pre-clinical drug/alcohol screen, including tetrahydrocannabinol.
* Positive Human Immunodeficiency Virus antibody test.
* History or regular use of tobacco or nicotine-containing products within 6 months prior to screening.
* Regular alcohol consumption within 6 months prior to screening defined as an average weekly intake of \>14 units for males or females.
* Regular use of known drugs of abuse, including tetrahydrocannabinol.
* Sensitivity to heparin or history of heparin-induced thrombocytopenia.
* History of sensitivity to bepirovirsen or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor contraindicates their participation.
* Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
* Positive test results for Hepatitis B surface antigen (HBsAg), hepatitis C antibody or hepatitis C RNA at screening or within 3 months prior to first dose of study intervention.
* Known history of heart disease, including ischemic heart disease, cardiomyopathy, clinically significant cardiac arrhythmias, clinically significant valvular disease, or hypertensive heart disease.

Where this trial is running

Austin, Texas

• GSK Investigational Site — Austin, Texas, United States (RECRUITING)

Study contacts

• Study coordinator: US GSK Clinical Trials Call Center

Conditions: Hepatitis B, Bepirovirsen, Cardiac Conduction, Electrocardiogram, QT interval corrected by Fridericia's formula, Hepatitis B virus