NCT07168356进行中（未招募）1 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 32
- 试验地点
- 4
- 主要终点
- Plasma Area Under the Concentration Time Curve From Time Zero (Pre-Dose) Extrapolated to Infinite Time [AUC(0-∞)] of Bepirovirsen
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This is an open-label study.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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).
研究组 & 干预措施
Group 3-Healthy Control Participants
Experimental
Healthy control participants will receive Bepirovirsen.
干预措施: Bepirovirsen (Drug)
Group 2- Moderate Renal Impairment Participants
Experimental
Participants with moderate renal impairment will receive Bepirovirsen.
干预措施: Bepirovirsen (Drug)
Group 1- Severe Renal Impairment Participants
Experimental
Participants with severe renal impairment will receive Bepirovirsen.
干预措施: Bepirovirsen (Drug)
结局指标
主要结局
Plasma Area Under the Concentration Time Curve From Time Zero (Pre-Dose) Extrapolated to Infinite Time [AUC(0-∞)] of Bepirovirsen
时间窗: Up to Day 50
Maximum Observed Concentration (Cmax) of Bepirovirsen
时间窗: Up to Day 50
次要结局
- 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 Half-life (t1/2) of Bepirovirsen(Up to Day 50)
- 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 Volume of Distribution (Vz/F) of Bepirovirsen(Up to Day 50)
研究者
研究点 (4)
Loading locations...
相似试验
已完成
1 期
Study to Evaluate the Pharmacokinetics and Safety of GSK2336805 in Subjects With Hepatic Impairment and Healthy Matched Control SubjectsHepatitis CNCT01827657GlaxoSmithKline31
已完成
1 期
A Study to Evaluate the Relative Bioavailability of Subcutaneous Bepirovirsen When Delivered From a Vial or Prefilled Syringe Fitted With a Safety Syringe Device in Healthy Adult ParticipantsHepatitis BNCT06058390GlaxoSmithKline160
已完成
1 期
Zoliflodacin Bioequivalence and Drug-Drug Interaction StudyHealthy VolunteersNCT05635305Global Antibiotics Research and Development Partnership50
已完成
1 期
Phase 1 PK Study to Evaluate the PK of CIN-107 in Subjects With Hepatic ImpairmentHypertensionNCT05961397AstraZeneca20
已完成
1 期
A Study to Assess the Pharmacokinetics and Safety of CSL312 in Healthy Japanese and Caucasian AdultsHealthy VolunteersNCT04580654CSL Behring38