A Study to Evaluate Blood Levels of Bepirovirsen in Adult Participants With Severe or Moderate Kidney Disease

Part of paid clinical trials in Orlando, Florida.

Sponsor
GlaxoSmithKline
Study ID
NCT07168356
Phase
PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

Study Details

This is a 2-part study where all participants will receive bepirovirsen. The study will measure how much bepirovirsen from a single dose gets into the blood, and how long it stays in the blood. The purpose of the study is to understand if blood levels of bepirovirsen are different in adults with kidney disease compared to healthy adults who do not have kidney disease.

Key Dates

Start date
Sep 26, 2025
Status verified
May 2026
Primary completion
Mar 3, 2026
Completion
Aug 18, 2026

Study Design

Enrollment
32 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1- Severe Renal Impairment Participants
    Participants with severe renal impairment will receive Bepirovirsen.
  • Experimental: Group 2- Moderate Renal Impairment Participants
    Participants with moderate renal impairment will receive Bepirovirsen.
  • Experimental: Group 3-Healthy Control Participants
    Healthy control participants will receive Bepirovirsen.

Primary Outcome Measure

Plasma Area Under the Concentration Time Curve From Time Zero (Pre-Dose) Extrapolated to Infinite Time [AUC(0-∞)] of Bepirovirsen [ Time Frame: Up to Day 50 ]

Locations (3)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteOrlandoFlorida32809-
GSK Investigational SiteTampaFlorida33603-
GSK Investigational SiteSan AntonioTexas78215-

Find similar trials in Orlando, FL

By research site
GSK Investigational Site· Orlando, FLGSK Investigational Site· Tampa, FLGSK Investigational Site· San Antonio, TX

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