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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-16

Study Completion Date

2026-08-18

Brief Summary

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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.

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Detailed Description

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Conditions

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Hepatitis B

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

This is an open-label study.

Study Groups

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Group 1- Severe Renal Impairment Participants

Participants with severe renal impairment will receive Bepirovirsen.

Group Type EXPERIMENTAL

Bepirovirsen

Intervention Type DRUG

Bepirovirsen will be administered.

Group 2- Moderate Renal Impairment Participants

Participants with moderate renal impairment will receive Bepirovirsen.

Group Type EXPERIMENTAL

Bepirovirsen

Intervention Type DRUG

Bepirovirsen will be administered.

Group 3-Healthy Control Participants

Healthy control participants will receive Bepirovirsen.

Group Type EXPERIMENTAL

Bepirovirsen

Intervention Type DRUG

Bepirovirsen will be administered.

Interventions

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Bepirovirsen

Bepirovirsen will be administered.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age 18 to 80 years, inclusive
* Body weight greater than or equal to 50 kilograms (kg) and body mass index (BMI) within the range 19 to 40 kilograms per square meter (kg/m\^2).
* Males and females may participate. Female participants must not be pregnant or breastfeeding, and must be of non-childbearing potential, or agree to use a highly effective method of contraception.
* Healthy, based on medical evaluation including medical history, physical examination, laboratory tests, and electrocardiogram (ECG).
* Normal renal function (eGFR adjusted for actual BSA greater than or equal to 90 ml/min)

Exclusion Criteria

* Any medical condition that could affect the absorption, metabolism, or elimination of drugs, increase the risk of taking part in the study, or interfere with interpretation of the study data.
* History of vasculitis or any type of glomerulonephritis
* Use of creatine-containing supplements within 30 days of screening or intended use during the study.
* Current enrolment in another interventional study, or past participation in a study where an investigational medicine, vaccine or device was administered if, at the time of consent, it is within 5 half-lives or twice the duration of the biological effect (whichever is longer) of the product given in the previous study.
* Received any oligonucleotide or small interfering ribonucleic acid (siRNA) within the past 12 months.
* Exposure to more than 4 investigational products within the past 12 months.
* A positive blood test for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).
* Average weekly alcohol intake of greater than 14 drinks for males or greater than 7 drinks for females.
* Current substance misuse or dependence, or a previous history of substance misuse or dependence that could interfere with ability to participate in the study.

* History of renal transplantation or anticipated renal transplant during the study.
* On dialysis or likely to require dialysis during the study.
* Positive drug or alcohol screen (unless because of prescribed medication). Additional exclusion criterion for healthy control group (Group 3)
* Positive drug or alcohol screen.
* Urine albumin-to-creatinine ratio (uACR) \> 0.3 mg/mg (300 mg/g).

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes