Hepatitis B
Conditions
Keywords
Bepirovirsen, Pharmacokinetics, Severe renal impairment, Moderate renal impairment, Healthy participants, Renal function, Kidney disease, Hepatitis B
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 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.
Interventions
DRUGBepirovirsen
Bepirovirsen will be administered.
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
This is an open-label study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma Area Under the Concentration Time Curve From Time Zero (Pre-Dose) Extrapolated to Infinite Time [AUC(0-∞)] of Bepirovirsen | Up to Day 50 |
| Maximum Observed Concentration (Cmax) of Bepirovirsen | Up to Day 50 |
Secondary
| Measure | Time frame |
|---|---|
| Plasma Area Under the Concentration Time Curve From Time Zero (Pre-Dose) to 24 hours [AUC(0-24)] of Bepirovirsen | 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 | Up to 168 hours |
| Observed Concentration of Bepirovirsen on Day 8 | At Day 8 |
| Apparent Terminal Phase Half-life (t1/2) of Bepirovirsen | Up to Day 50 |
| Apparent Clearance (CL/F) of Bepirovirsen | Up to Day 50 |
| Time of Occurrence of Cmax (Tmax) of Bepirovirsen | Up to Day 50 |
| Apparent Terminal Phase Volume of Distribution (Vz/F) of Bepirovirsen | Up to Day 50 |
Countries
United States
Contacts
STUDY_DIRECTORGSK Clinical Trials
GlaxoSmithKline
Outcome results
None listed