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

Status: Completed
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: t
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• 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.

Locations
United States
Texas
GSK Investigational Site
Austin
Time Frame
Start Date: 2024-07-18
Completion Date: 2025-04-28
Participants
Target number of participants: 46
Treatments
Experimental: Participants receiving Bepirovirsen
Placebo_comparator: Participants receiving Placebo
Related Therapeutic Areas
Sponsors
Collaborators: PPD Development, LP
Leads: GlaxoSmithKline

This content was sourced from clinicaltrials.gov