An Open-label, Single-dose, Parallel-group Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of JNJ-73763989 in Adult Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Plasma Concentration of JNJ-73763989
研究概览
简要总结
The purpose of this study is to evaluate the pharmacokinetics (PK) of a single subcutaneous (SC) dose of JNJ-73763989 in adult participants with renal impairment compared with healthy participants with normal renal function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •Must have stable renal function defined as a less than (<) 20 percent (%) change in serum creatinine concentrations between screening and Day -1
- •Concomitant medications should be stable for the previous 1 month and throughout the duration of the study
- •Women, except for postmenopausal women, must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) at screening and urine (beta-hCG) pregnancy test on Day -1
- •Must sign an informed consent form (ICF) indicating they understand the purpose of, and procedures required for the study and are willing to participate in the study
- •Participants with kidney disease without dialysis using benzodiazepines, tricyclic antidepressants, and prescription opiates with a positive urine test for drugs prescribed by their physician may be included following prior discussion with the sponsor
排除标准
- •Have kidney disease requiring dialysis
- •Renal transplants, systemic lupus erythematosus, or participant with malignancy
- •Known allergies, hypersensitivity, or intolerance to JNJ-73763989 or its excipients
- •Received an experimental drug (including investigational vaccines) or used an experimental medical device within 1 month or within a period less than 10 times the drug's half-life, whichever is longer, before the administration of the study drug is scheduled
- •Preplanned surgery or procedures that would interfere with the conduct of the study
研究组 & 干预措施
Group 1: JNJ-73763989
Participants with moderate renal impairment will receive a single subcutaneous (SC) injection of JNJ-73763989 on Day 1.
干预措施: JNJ-73763989 (Drug)
Group 2: JNJ-73763989
Participants with severe renal impairment or end-stage renal disease (ESRD) will receive a single SC injection of JNJ-73763989 on Day 1.
干预措施: JNJ-73763989 (Drug)
Group 3: JNJ-73763989
Participants with normal renal function will receive a single SC injection of JNJ-73763989 on Day 1.
干预措施: JNJ-73763989 (Drug)
结局指标
主要结局
Plasma Concentration of JNJ-73763989
时间窗: Predose, up to 72 hours postdose (up to Day 4)
Plasma samples will be analyzed to determine concentrations of JNJ-73763989 (as the 2 triggers JNJ-73763976 and JNJ-73763924) using a validated and qualified method.
次要结局
- Number of Participants with AEs by Severity Grades(Up to 42 days)
- Number of Participants with Adverse Events (AEs)(Up to 42 days)
- Number of Participants with Abnormalities in Clinical Laboratory Tests, Electrocardiograms (ECGs), Vital Signs and Physical Examination(Up to 42 days)