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

Part of paid clinical trials in Austin, Texas.

Sponsor
GlaxoSmithKline
Study ID
NCT06422767
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Bepirovirsen — DRUG
    Bepirovirsen will be administered.
  • Placebo — DRUG
    Placebo will be administered.

Study Details

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.

Key Dates

Start date
Jul 18, 2024
Status verified
Jun 2025
Primary completion
Apr 28, 2025
Completion
Apr 28, 2025

Study Design

Enrollment
46 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Participants receiving Bepirovirsen
  • Placebo Comparator: Participants receiving Placebo

Primary Outcome Measure

Change from Baseline in QT interval corrected by Fridericia's formula (QTcF) [ Time Frame: Baseline (Day 1) and up to Day 4 ]

Locations (1)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteAustinTexas78744 -1645-

Find similar trials in Austin, TX

By research site
GSK Investigational Site· Austin, TX

Related Studies