NCT04116476已完成1 期
An Open-label, Single-center, Parallel-group Study to Assess Pharmacokinetics, Safety, and Tolerability of a Single Dose of MT-7117 in Subjects With Normal and Impaired Hepatic Function
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Area under the plasma concentration time curve from time zero to infinity (AUC0-∞) of MT-7117
研究概览
简要总结
An Open-label, Single-center, Parallel-group Study to Assess Pharmacokinetics, Safety, and Tolerability of a Single Dose of MT-7117 in Subjects with Normal and Impaired Hepatic Function
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female subjects 18 to 75 years of age inclusive
- •BMI 18 -35 kg/m2
- •If female, you are nonpregnant, non-lactating and willing to utilize approved methods of birth control.
排除标准
- •Subjects who have mild or moderate hepatic impairment according to Child-Pugh classification system at Screening (except normal healthy matches)
- •Subjects who have a known clinically significant (CS) hypersensitivity to MT-7117 or related compounds, including melatonin.
- •Subjects who have previously participated in a study involving MT-7117 or taken any other investigational drug within 30 days or 5 half-lives prior to the first dose of IMP, whichever is longer.
- •Subjects who have a CS or unstable neurological, renal, cardiovascular, gastrointestinal, pulmonary, or hematologic disease for 14 days prior to enrollment.
- •Subjects who have used any prescription or over-the-counter (OTC) medication within 14 days prior to first dose of IMP, except for occasional use of acetaminophen (< 1 g/day for normal hepatic subjects, and < 2 g/day for hepatically impaired subjects) or any other medication approved by the sponsor (a case-by-case basis). For hepatic impaired subjects, prescribed medication or OTC may be permitted by the Investigator and sponsor on a case-by-case basis.
研究组 & 干预措施
Moderate Hepatic Impairment
Experimental
干预措施: MT-7117 (Drug)
Normal Healthy Matches
Experimental
干预措施: MT-7117 (Drug)
Mild Hepatic Impairment
Experimental
干预措施: MT-7117 (Drug)
结局指标
主要结局
Area under the plasma concentration time curve from time zero to infinity (AUC0-∞) of MT-7117
时间窗: 0-96 Hours
Maximum observed plasma concentration (Cmax) of MT-7117
时间窗: 0-96 Hours
Area under the plasma concentration time curve from time zero to the time of last quantifiable concentration (AUC0-last) of MT-7117
时间窗: 0-96 Hours
次要结局
- Apparent volume of distribution (Vz/F) of MT-7117(0-96 Hours)
- fraction of unbound drug in plasma or serum (fu) of MT-7117(0-96 Hours)
- Time to reach maximum plasma concentration (tmax) of MT-7117(0-96 Hours)
- Plasma terminal elimination half-life (t1/2) of MT-7117(0-96 Hours)
- Apparent oral clearance (CL/F) of MT-7117(0-96 Hours)
- Number of participants with Adverse events (AEs) and Serious Adverse Events (SAEs)(0-96 Hours)
研究者
研究点 (1)
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