NCT06589713已完成1 期
Phase 1, Open Label, Single Dose Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics of Enpatoran in Male and Female Participants
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2024年9月24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
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Pharmacokinetic (PK) Plasma Concentrations of Enpatoran
研究概览
简要总结
The purpose of this study is to assess the effect of renal impairment on the pharmacokinetics of enpatoran.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 否
入选标准
- •For Control Group 1 (Normal Renal Function):
- •Medical history and physical examination without any ongoing clinically relevant findings as judged by the Investigator
- •No clinically relevant findings (only minor deviations) in biochemistry, hematology, coagulation, and urinalysis examinations for the age of the participant, as judged by the Investigator; absolute lymphocyte count and absolute neutrophil count must be within normal limits
- •For Group 2 (Impaired Renal Function):
- •Medical history and physical examination without any ongoing clinically relevant findings except for the underlying disease leading to renal impairment and consequence diseases thereof
- •Chronic kidney disease
- •For participants under medication, stable medication for at least 1 month
- •Other protocol defined inclusion criteria could apply
排除标准
- •History or presence of respiratory, gastrointestinal (including bariatric or other gastric surgeries, or other conditions that may affect drug absorption), hepatic (including hepatorenal syndrome), hematological, lymphatic, cardiovascular (such as ventricular dysfunction and congestive heart failure, cardiac arrythmia), psychiatric, neurological, genitourinary, immunological, dermatological, connective tissue diseases, or disorders that may affect the safety of the participant.
- •History of drug hypersensitivity, ascertained or presumptive allergy/hypersensitivity to the active drug substance and/or formulation ingredients; history of serious allergic reactions leading to hospitalization or any other hypersensitivity reaction in general, which may affect the safety of the participant and/or outcome of the study per the Investigator's discretion
- •History or presence of epilepsy, neurological disorders with seizure propensity or undiagnosed loss of consciousness, severe head trauma within 6 months or severe depression within 12 months prior to Screening), or neuropsychiatric conditions
- •History of serotonin syndrome
- •Prior history of cholecystectomy or splenectomy, and any clinically relevant surgery within 6 months prior to Screening, which might interfere with the objectives of the study or the study procedures
- •Other protocol defined exclusion criteria could apply
研究组 & 干预措施
Control Group 1 (Normal Renal Function)
Experimental
干预措施: Enpatoran (Drug)
Group 2 (Impaired Renal Function)
Experimental
干预措施: Enpatoran (Drug)
结局指标
主要结局
Pharmacokinetic (PK) Plasma Concentrations of Enpatoran
时间窗: Predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, and 48 hours postdose
次要结局
- Number of Participants with Treatment-Emergent Adverse Events (TEAEs)(Up to Day 35)
- Number of Participants with Abnormal Vital Signs, Laboratory Variables and 12-Lead Electrocardiogram (ECG)(Baseline and up to Day 35)
研究者
研究点 (1)
Loading locations...
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