Trials / Recruiting
RecruitingNCT07168356
A Study to Evaluate Blood Levels of Bepirovirsen in Adult Participants With Severe or Moderate Kidney Disease
A Phase 1, Open-Label, Single-Dose, Parallel Group, 2-Part Study to Evaluate the Pharmacokinetics of Bepirovirsen in Adult Participants With Severe or Moderate Renal Impairment Compared to Matched Healthy Control Participants
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 32 (estimated)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Bepirovirsen | Bepirovirsen will be administered. |
Timeline
- Start date
- 2025-09-16
- Primary completion
- 2026-04-28
- Completion
- 2026-08-18
- First posted
- 2025-09-11
- Last updated
- 2025-10-15
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07168356. Inclusion in this directory is not an endorsement.