Study to Evaluate the Effect of Bepirovirsen on Cardiac Conduction as Assessed by 12-lead Electrocardiogram in Healthy Volunteers

NCT06422767 | Completed Phase 1 FDA Drug

• 1 other identifier: 205873
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the effect of a single dose of bepirovirsen on the QT interval corrected by Fridericia's formula (QTcF) as compared to placebo. The data generated will be used to model the relationship between bepirovirsen concentration and QTcF.

Conditions

Hepatitis B

Keywords

Bepirovirsen; Cardiac Conduction; Electrocardiogram; QT interval corrected by Fridericia's formula; Hepatitis B virus

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in QT interval corrected by Fridericia's formula (QTcF)

  Baseline (Day 1) and up to Day 4

Secondary Outcomes (11)

• Change from Baseline in heart rate (HR) using by-time point analysis

  Baseline (Day 1) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 27, 30, 33, 36, 48, 51, 54, 57, 60 and 72 hours post-dose

• Change from Baseline in QT interval, corrected by Fridericia's formula (QTcF), using by-time point analysis

  Baseline (Day 1) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 27, 30, 33, 36, 48, 51, 54, 57, 60 and 72 hours post-dose

• Change from Baseline in PR interval using by-time point analysis

  Baseline (Day 1) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 27, 30, 33, 36, 48, 51, 54, 57, 60 and 72 hours post-dose

• Change from Baseline in QRS duration using by-time point analysis

  Baseline (Day 1) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 27, 30, 33, 36, 48, 51, 54, 57, 60 and 72 hours post-dose

• Number of participants with outlier results for QT interval, corrected by Fridericia's formula (QTcF), HR, PR and QRS

  Up to Day 4

Study Arms (2)

Participants receiving Bepirovirsen

EXPERIMENTAL

Drug: Bepirovirsen

Participants receiving Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Bepirovirsen DRUG

Bepirovirsen will be administered.

Participants receiving Bepirovirsen

Placebo DRUG

Placebo will be administered.

Participants receiving Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead
• PPD Development, LP: collaborator

Study Sites (1)

GSK Investigational Site

Austin, Texas, 78744 -1645, United States

Location

MeSH Terms

Conditions

Hepatitis B

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

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This will be a double-blind study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: May 21, 2024
• Study Start: July 18, 2024
• Primary Completion: April 28, 2025
• Study Completion: April 28, 2025
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an 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 may be granted, when justified, for up to 6 months.

Locations

US (1)