Last updated: 10/14/2025 09:00:09
A Study to Evaluate Blood Levels of Bepirovirsen in Adult Participants with Severe or Moderate Kidney DiseaseB-Kind
GSK study ID
205872
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Recruiting
Recruiting
Trial overview
Official title: 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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Plasma Area Under the Concentration Time Curve From Time Zero (Pre-Dose) Extrapolated to Infinite Time [AUC(0-∞)] of Bepirovirsen
Timeframe: Up to Day 50
Maximum Observed Concentration (Cmax) of Bepirovirsen
Timeframe: Up to Day 50
Secondary outcomes:
Plasma Area Under the Concentration Time Curve From Time Zero (Pre-Dose) to 24 hours [AUC(0-24)] of Bepirovirsen
Timeframe: Up to 24 hours
Plasma Area Under the Concentration Time Curve From Time Zero (Pre-Dose) to 168 hours (Day 8) [AUC(0-168)] of Bepirovirsen
Timeframe: Up to 168 hours
Observed Concentration of Bepirovirsen on Day 8
Timeframe: At Day 8
Apparent Terminal Phase Half-life (t1/2) of Bepirovirsen
Timeframe: Up to Day 50
Apparent Clearance (CL/F) of Bepirovirsen
Timeframe: Up to Day 50
Time of Occurrence of Cmax (Tmax) of Bepirovirsen
Timeframe: Up to Day 50
Apparent Terminal Phase Volume of Distribution (Vz/F) of Bepirovirsen
Timeframe: Up to Day 50
Interventions:
Enrollment:
32
Primary completion date:
2026-28-04
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Hepatitis B
Product
Not applicable
Collaborators
Not applicable
Study date(s)
September 2025 to August 2026
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 80 Years
Accepts healthy volunteers
Yes
- 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).
- 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
Inclusion and exclusion criteria
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.
- 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 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. 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).
Trial location(s)
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Recruiting
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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