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 was administered.
  • Placebo — DRUG
    Placebo was 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

First listed
May 21, 2024
Start date
Jul 18, 2024
Status verified
Jun 2026
Primary completion
Apr 28, 2025
Completion
Apr 28, 2025

Study Design

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

Arms

  • Active Comparator: Bepirovirsen: Four-Dose SC Injection
    Participant received four subcutaneous (SC) injections of Bepirovirsen dose level 1 on Day 1.
  • Placebo Comparator: Placebo: Four SC Injections
    Participants received four matching placebo SC injections on Day 1.
  • Active Comparator: Bepirovirsen: Three-Dose SC Injection
    Participant received three SC injections of Bepirovirsen dose level 1 on Day 1.
  • Placebo Comparator: Placebo: Three SC Injections
    Participants received three matching placebo SC injections on Day 1.

Primary Outcome Measure

Placebo-corrected Change From Baseline (CFB) in QT Interval Corrected by Fridericia's Formula (QTcF) Following Administration of Bepirovirsen Supratherapeutic Single Dose [ Time Frame: Baseline (Pre-dose on Day 1) and Day 4 ]

Locations (1)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteAustinTexas78744 -1645-

Find similar trials in Austin, TX

By research site
GSK Investigational Site· Austin, TX

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