NCT07713758招募中1 期
A Phase 1, Open-label, Single-dose, Parallel-group Study Evaluating the Pharmacokinetics of Oral Repinatrabit (JNT-517) Immediate Release Tablet in Hepatic or Renal Impaired Adult Participants Matched to Adult Participants With Normal Hepatic and Renal Function
Otsuka Pharmaceutical Development & Commercialization, Inc.1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2026年7月17日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Groups 1 and 2: Unbound and Total Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Repinatrabit
研究概览
简要总结
This trial is intended to understand how the body processes repinatrabit in people with moderate liver impairment and severe kidney impairment and also to compare these results with people of similar age, weight, and sex who have normal liver 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
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) from 18.0 to 38.0 kilograms per square meter (kg/m^2) (inclusive).
- •Able to provide written, informed consent.
- •Male participants and female participants of childbearing potential (POCBP) must agree to remain fully abstinent from intercourse where pregnancy can occur OR practice 2 different contraceptive methods, where at least one must be highly effective.
- •Otherwise be in generally good health.
- •Additional criteria for Group 1:
- •i. Have moderate hepatic impairment determined using Child-Pugh classification (Class B).
- •ii. Have relatively stable hepatic function for the duration of the study as determined by the investigator and liver function test at the time of screening or stable hepatic function 1 year prior to screening.
- •iii. Have normal renal function. iv. Have a clinical diagnosis of hepatic cirrhosis based on biopsy and/or clinical criteria.
- •Additional criteria for Group 2:
- •i. Have estimated glomerular filtration rate based on the Chronic Kidney Disease-Epidemiology Collaboration (eGFRCKD-EPI) lesser than (<) 30 milliliters per minute per 1.73 square meters (mL/min/1.73 m^2) indicating severe renal impairment.
- •ii. Not currently be on dialysis. iii. Have relatively stable renal function as determined by eGFRCKD-EPI. 7) Additional criteria for Group 3: i. eGFRCKD-EPI greater than or equal to (≥) 90 mL/min/1.73 m^2 indicating normal renal function.
- •ii. Have liver enzymes within normal limits.
排除标准
- •Participants who are breastfeeding.
- •Participants who have a positive pregnancy test result prior to receiving the investigational medical product (IMP).
- •Participants with international normalized ratio (INR) greater than (>) 2.
- •Participants with hepatic impairment with elevated INR will be excluded based on the investigator's discretion.
- •Participants with hepatic carcinoma or porto-hepatic shunts that have been surgically created or planted.
- •A history of difficulty in obtaining intravenous access.
- •The donation of blood or plasma > 250 milliliters (mL) within 30 days prior to screening or received > 50 mL of blood or plasma within 30 days prior to screening.
- •Participants who have taken an investigational drug within 30 days prior to screening.
- •Exposure to any substances known to stimulate hepatic microsomal enzymes within 30 days prior to screening (eg, occupational exposure to pesticides, organic solvents, etc).
- •Any participant who, in the opinion of the investigator, should not participate in the trial.
- •Previous exposure to repinatrabit.
- •Additional criteria for Group 1: History of serious mental disorder including participants who have greater than Grade 1 encephalopathy as assessed by the Child-Pugh score and/or the investigator's judgment.
- •Additional criteria for Group 2:
- •i) Participants that have undergone a renal transplant. ii) Participants expected to require dialysis within 45 days. iii) Clinically significant abnormal findings in the serum chemistry, hematology, or urinalysis results obtained at screening or on Day -1, other than those associated with underlying renal conditions and other stable medical conditions consistent with the disease processes.
- •Additional criteria for Group 3: History of or current hepatitis, or carriers of hepatitis B surface antigen (HBsAg) and/or hepatitis C antibodies (anti-HC).
- •Note: Other protocol-specified inclusion/exclusion criteria may apply.
研究组 & 干预措施
Group 1: Moderate Hepatic Impairment
Experimental
Participants with moderate hepatic impairment will receive a single dose of repinatrabit tablet, under fasted conditions on Day 1.
干预措施: Repinatrabit (Drug)
Group 3: Matched Normal Hepatic and Renal Function
Experimental
Participants matched by age, weight, and sex with normal hepatic and renal function will receive a single dose of repinatrabit tablet, under fasted conditions on Day 1.
干预措施: Repinatrabit (Drug)
Group 2: Severe Renal Impairment
Experimental
Participants with severe renal impairment will receive a single dose of repinatrabit tablet, under fasted conditions on Day 1.
干预措施: Repinatrabit (Drug)
结局指标
主要结局
Groups 1 and 2: Unbound and Total Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Repinatrabit
时间窗: From Day 1 to Day 8
Groups 1 and 2: Unbound and Total Maximum (Peak) Plasma Concentration (Cmax) of Repinatrabit
时间窗: From Day 1 to Day 8
Groups 1 and 2: Unbound and Total Area Under the Concentration-Time Curve Calculated to the Last Observable Concentration at Time t (AUC0-t) of Repinatrabit
时间窗: From Day 1 to Day 8
次要结局
- All Groups: Number of Participants With Potentially Clinically Relevant Clinical Laboratory Test Results(Up to Day 8)
- All Groups: Number of Participants With Potentially Clinically Relevant Changes in Vital Signs(Up to Day 8)
- All Groups: Number of Participants With Potentially Clinically Relevant Changes in Physical Examination Findings(Up to Day 8)
- All Groups: Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Severe Adverse Events (SAEs)(Up to Day 14)
- All Groups: Number of Participants With Potentially Clinically Relevant Changes in 12-lead Electrocardiogram (ECG) Results(Up to Day 8)
研究者
研究点 (1)
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