NCT07168356
A Study to Evaluate Blood Levels of Bepirovirsen in Adult Participants With Severe or Moderate Kidney Disease
Active, Not Recruiting
PHASE1Ages 18–80InterventionalTreatmentGlaxoSmithKline
~32 participants
Updated 2026-05-22 on ClinicalTrials.gov
What's tested:Bepirovirsen
At a glance
Recruiting sites
0 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Plasma Area Under the Concentration Time Curve From Time Zero (Pre-Dose) Extrapolated to Infinite Time [AUC(0-∞)] of Bepirovirsen
Measured over Up to Day 50
+1 more outcome measured
Conditions
Where it's being run
3 sites across 2 statesFlorida2
Texas1
Study leadership
- GSK Clinical Trials · STUDY_DIRECTOR · GlaxoSmithKline
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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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.
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.
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).
What this trial measures
- Plasma Area Under the Concentration Time Curve From Time Zero (Pre-Dose) Extrapolated to Infinite Time [AUC(0-∞)] of BepirovirsenUp to Day 50
- Maximum Observed Concentration (Cmax) of BepirovirsenUp to Day 50