Status:
RECRUITING
A Study to Evaluate Blood Levels of Bepirovirsen in Adult Participants With Severe or Moderate Kidney Disease
Lead Sponsor:
GlaxoSmithKline
Conditions:
Hepatitis B
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief 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 pu...
Eligibility Criteria
Inclusion
- 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.
- Capable of giving signed informed consent Additional inclusion criteria for renal impairment groups (Group 1 and Group 2)
- Severe renal impairment \[estimated glomerular filtration rate (eGFR) adjusted for actual body surface area (BSA) less than 30 milliliters per minute (ml/min); Group 1\] or moderate renal impairment \[eGFR adjusted for actual BSA between 30 and 59 ml/min; Group 2\], from any cause other than vasculitis or glomerulonephritis Additional inclusion criteria for healthy control participants with normal renal function (Group 3)
- 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
- 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.
- Additional exclusion criteria for renal impairment groups (Group 1 and Group 2)
- 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).
Key Trial Info
Start Date :
September 16 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 18 2026
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT07168356
Start Date
September 16 2025
End Date
August 18 2026
Last Update
October 15 2025
Active Locations (1)
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1
GSK Investigational Site
Tampa, Florida, United States, 33603