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临床试验/NCT04481750
NCT04481750已完成1 期

Phase I Study of Oral Edaravone in Healthy Adult Males (Single- and Multiple-dose Study)

Shionogi1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2018年3月20日最近更新:
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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
74
试验地点
1
主要终点
Number of Participants With Adverse Events (Aes) and Adverse Drug Reactions (ADRs)
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

To evaluate the pharmacokinetics safety, and tolerability of single and multiple doses of edaravone solution and suspension in healthy adult males

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

盲法说明

Single Blind

入排标准

年龄范围
20 Years 至 45 Years（Adult）
性别
Male
接受健康志愿者
是

入选标准

  • •Additional screening criteria check may apply for qualification:
  • •Healthy adult male volunteers
  • •Japanese or Caucasian
  • •Subjects aged between 20 and 45 years at the time of informed consent
  • •Subjects who have thoroughly understood the contents of the study and voluntarily provided written informed consent to participate in the study

排除标准

  • •Additional screening criteria check may apply for qualification:
  • •Subjects with a current or previous history of cardiac, hepatic, renal, gastrointestinal, respiratory, psychiatric/nervous, hematopoietic, or endocrine diseases, and those whom the investigator (or subinvestigator) deems unsuitable for the study
  • •Body mass index (BMI) of <18.0 or >30.0, or body weight of <50 kg (BMI formula: body weight [kg]/height [m]2, rounded to one decimal place)
  • •Subjects who have undergone any surgery known to affect the gastrointestinal absorption of drugs
  • •Subjects who do not agree to use an effective method of contraception from initiation of study drug administration to 14 days after completion (discontinuation) of study drug administration
  • •Subjects who have previously received edaravone
  • •Subjects who have participated in another clinical study and received a study drug within 12 weeks before providing informed consent

研究组 & 干预措施

A single dose MT-1186 (Part 1, Cohort S2)

Experimental

Healthy Japanese male subjects receive a single dose of MT-1186 or matching placebo.

干预措施: MT-1186 (Drug)

A single dose MT-1186 (Part 1, Cohort S5)

Experimental

Healthy Japanese male subjects receive a single dose of MT-1186 or matching placebo.

干预措施: MT-1186-matching placebo (Drug)

A single dose MT-1186 (Part 1, Cohort S6)

Experimental

Healthy Japanese male subjects receive a single dose of MT-1186 or matching placebo.

干预措施: MT-1186-matching placebo (Drug)

A single dose MT-1186 (Part 1, Cohort S7)

Experimental

Healthy Caucasian male subjects receive a single dose of MT-1186 or matching placebo.

干预措施: MT-1186 (Drug)

Multiple doses MT-1186 (Part 2, Cohort M1)

Experimental

Healthy Japanese male subjects receive multiple doses of MT-1186 or matching placebo.

干预措施: MT-1186-matching placebo (Drug)

Multiple doses MT-1186 (Part 2, Cohort M2)

Experimental

Healthy Japanese male subjects receive multiple doses of MT-1186 or matching placebo

干预措施: MT-1186-matching placebo (Drug)

A single dose MT-1186 (Part 1, Cohort S3-2)

Experimental

Healthy Japanese male subjects receive doses of MT-1186 or matching placebo.

干预措施: MT-1186 (Drug)

A single dose MT-1186 (Part 1, Cohort S1)

Experimental

Healthy Japanese male subjects receive a single dose of MT-1186 or matching placebo.

干预措施: MT-1186 (Drug)

A single dose MT-1186 (Part 1, Cohort S1)

Experimental

Healthy Japanese male subjects receive a single dose of MT-1186 or matching placebo.

干预措施: MT-1186-matching placebo (Drug)

A single dose MT-1186 (Part 1, Cohort S2)

Experimental

Healthy Japanese male subjects receive a single dose of MT-1186 or matching placebo.

干预措施: MT-1186-matching placebo (Drug)

A single dose MT-1186 (Part 1, Cohort S3-1)

Experimental

Healthy Japanese male subjects receive doses of MT-1186 or matching placebo.

干预措施: MT-1186-matching placebo (Drug)

A single dose MT-1186 (Part 1, Cohort S3-2)

Experimental

Healthy Japanese male subjects receive doses of MT-1186 or matching placebo.

干预措施: MT-1186-matching placebo (Drug)

A single dose MT-1186 (Part 1, Cohort S4)

Experimental

Healthy Japanese male subjects receive a single dose of MT-1186 or matching placebo.

干预措施: MT-1186-matching placebo (Drug)

A single dose MT-1186 (Part 1, Cohort S5)

Experimental

Healthy Japanese male subjects receive a single dose of MT-1186 or matching placebo.

干预措施: MT-1186 (Drug)

A single dose MT-1186 (Part 1, Cohort S6)

Experimental

Healthy Japanese male subjects receive a single dose of MT-1186 or matching placebo.

干预措施: MT-1186 (Drug)

Multiple doses MT-1186 (Part 2, Cohort M2)

Experimental

Healthy Japanese male subjects receive multiple doses of MT-1186 or matching placebo

干预措施: MT-1186 (Drug)

A single dose MT-1186 (Part 1, Cohort S4)

Experimental

Healthy Japanese male subjects receive a single dose of MT-1186 or matching placebo.

干预措施: MT-1186 (Drug)

Multiple doses MT-1186 (Part 2, Cohort M1)

Experimental

Healthy Japanese male subjects receive multiple doses of MT-1186 or matching placebo.

干预措施: MT-1186 (Drug)

A single dose MT-1186 (Part 1, Cohort S3-1)

Experimental

Healthy Japanese male subjects receive doses of MT-1186 or matching placebo.

干预措施: MT-1186 (Drug)

A single dose MT-1186 (Part 1, Cohort S7)

Experimental

Healthy Caucasian male subjects receive a single dose of MT-1186 or matching placebo.

干预措施: MT-1186-matching placebo (Drug)

结局指标

主要结局

Number of Participants With Adverse Events (Aes) and Adverse Drug Reactions (ADRs)

时间窗: Day 1 to 8 in Part 1, up to 12 days in Part 2

Area Under the Concentration Versus Time Curve (AUC) of Unchanged Edaravone

时间窗: Part 1: Pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12, 24, 36, 48 hrs post-dose, Part 2: Day 1 and 5 at pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12 hrs post-dose; Day 2 to 4 at pre-dose; Day 6 at 24 hrs post-dose on Day 5; Day 7 at 48 hrs post-dose on Day 5

Area under the plasma concentration versus time curve from time zero up to 24 hours (AUC0-24) of unchanged edaravone.

Area Under the Concentration Versus Time Curve (AUC) of Sulfate Conjugate

时间窗: Part 1: Pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12, 24, 36, 48 hrs post-dose, Part 2: Day 1 and 5 at pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12 hrs post-dose; Day 2 to 4 at pre-dose; Day 6 at 24 hrs post-dose on Day 5; Day 7 at 48 hrs post-dose on Day 5

Area under the plasma concentration versus time curve from time zero up to 24 hours (AUC0-24) of sulfate conjugate.

Maximum Plasma Concentration (Cmax) of Glucuronide Conjugate

时间窗: Part 1: Pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12, 24, 36, 48 hrs post-dose, Part 2: Day 1 and 5 at pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12 hrs post-dose; Day 2 to 4 at pre-dose; Day 6 at 24 hrs post-dose on Day 5; Day 7 at 48 hrs post-dose on Day 5

Part 2: Minimum Plasma Concentration at Steady State (Ctrough, ss)

时间窗: Part 2: Day 1 and 5 at pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12 hrs post-dose; Day 2 to 4 at pre-dose; Day 6 at 24 hrs post-dose on Day 5; Day 7 at 48 hrs post-dose on Day 5

Time to Reach Maximum Plasma Concentration (Tmax) of Sulfate Conjugate

时间窗: Part 1: Pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12, 24, 36, 48 hrs post-dose, Part 2: Day 1 and 5 at pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12 hrs post-dose; Day 2 to 4 at pre-dose; Day 6 at 24 hrs post-dose on Day 5; Day 7 at 48 hrs post-dose on Day 5

Area Under the Concentration Versus Time Curve (AUC) of Glucuronide Conjugate

时间窗: Part 1: Pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12, 24, 36, 48 hrs post-dose, Part 2: Day 1 and 5 at pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12 hrs post-dose; Day 2 to 4 at pre-dose; Day 6 at 24 hrs post-dose on Day 5; Day 7 at 48 hrs post-dose on Day 5

Area under the plasma concentration versus time curve from time zero up to 24 hours (AUC0-24) of glucuronide conjugate.

Maximum Plasma Concentration (Cmax) of Unchanged Edaravone

时间窗: Part 1: Pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12, 24, 36, 48 hrs post-dose, Part 2: Day 1 and 5 at pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12 hrs post-dose; Day 2 to 4 at pre-dose; Day 6 at 24 hrs post-dose on Day 5; Day 7 at 48 hrs post-dose on Day 5

Maximum Plasma Concentration (Cmax) of Sulfate Conjugate

时间窗: Part 1: Pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12, 24, 36, 48 hrs post-dose, Part 2: Day 1 and 5 at pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12 hrs post-dose; Day 2 to 4 at pre-dose; Day 6 at 24 hrs post-dose on Day 5; Day 7 at 48 hrs post-dose on Day 5

Time to Reach Maximum Plasma Concentration (Tmax) of Unchanged Edaravone

时间窗: Part 1: Pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12, 24, 36, 48 hrs post-dose, Part 2: Day 1 and 5 at pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12 hrs post-dose; Day 2 to 4 at pre-dose; Day 6 at 24 hrs post-dose on Day 5; Day 7 at 48 hrs post-dose on Day 5

Time to Reach Maximum Plasma Concentration (Tmax) of Glucuronide Conjugate

时间窗: Part 1: Pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12, 24, 36, 48 hrs post-dose, Part 2: Day 1 and 5 at pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12 hrs post-dose; Day 2 to 4 at pre-dose; Day 6 at 24 hrs post-dose on Day 5; Day 7 at 48 hrs post-dose on Day 5

Terminal Elimination Half-life (t1/2) of Glucuronide Conjugate

时间窗: Part 1: Pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12, 24, 36, 48 hrs post-dose, Part 2: Day 1 and 5 at pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12 hrs post-dose; Day 2 to 4 at pre-dose; Day 6 at 24 hrs post-dose on Day 5; Day 7 at 48 hrs post-dose on Day 5

Lambda-z of Unchanged Edaravone

时间窗: Part 1: Pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12, 24, 36, 48 hrs post-dose, Part 2: Day 1 and 5 at pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12 hrs post-dose; Day 2 to 4 at pre-dose; Day 6 at 24 hrs post-dose on Day 5; Day 7 at 48 hrs post-dose on Day 5

Lambda-z of Sulfate Conjugate

时间窗: Part 1: Pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12, 24, 36, 48 hrs post-dose, Part 2: Day 1 and 5 at pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12 hrs post-dose; Day 2 to 4 at pre-dose; Day 6 at 24 hrs post-dose on Day 5; Day 7 at 48 hrs post-dose on Day 5

Lambda-z of Glucuronide Conjugate

时间窗: Part 1: Pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12, 24, 36, 48 hrs post-dose, Part 2: Day 1 and 5 at pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12 hrs post-dose; Day 2 to 4 at pre-dose; Day 6 at 24 hrs post-dose on Day 5; Day 7 at 48 hrs post-dose on Day 5

Mean Residence Time (MRT) of Unchanged Edaravone

时间窗: Part 1: Pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12, 24, 36, 48 hrs post-dose Part 2: Day 1 and 5 at pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12 hrs post-dose; Day 2 to 4 at pre-dose; Day 6 at 24 hrs post-dose on Day 5; Day 7 at 48 hrs post-dose on Day 5

Apparent Total Clearance (CL/F) of Unchanged Edaravone

时间窗: Part 1: Pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12, 24, 36, 48 hrs post-dose, Part 2: Day 1 and 5 at pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12 hrs post-dose; Day 2 to 4 at pre-dose; Day 6 at 24 hrs post-dose on Day 5; Day 7 at 48 hrs post-dose on Day 5

Apparent Distribution Volume at Elimination Phase (Vz/F) and Apparent Distribution Volume at Steady State (Vss/F) of Unchanged Edaravone

时间窗: Part 1: Pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12, 24, 36, 48 hrs post-dose, Part 2: Day 1 and 5 at pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12 hrs post-dose; Day 2 to 4 at pre-dose; Day 6 at 24 hrs post-dose on Day 5; Day 7 at 48 hrs post-dose on Day 5

Terminal Elimination Half-life (t1/2) of Unchanged Edaravone

时间窗: Part 1: Pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12, 24, 36, 48 hrs post-dose, Part 2: Day 1 and 5 at pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12 hrs post-dose; Day 2 to 4 at pre-dose; Day 6 at 24 hrs post-dose on Day 5; Day 7 at 48 hrs post-dose on Day 5

Terminal Elimination Half-life (t1/2) of Sulfate Conjugate

时间窗: Part 1: Pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12, 24, 36, 48 hrs post-dose, Part 2: Day 1 and 5 at pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12 hrs post-dose; Day 2 to 4 at pre-dose; Day 6 at 24 hrs post-dose on Day 5; Day 7 at 48 hrs post-dose on Day 5

次要结局

  • Change of QTcF Interval (QTcF) From Baseline(0.75, 0.5, and 0.25 hours pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 36, and 48 hours post-dose.)
  • Change of QRS Duration (QRS) From Baseline(0.75, 0.5, and 0.25 hours pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 36, and 48 hours post-dose.)
  • Change of Heart Rate (HR) From Baseline(0.75, 0.5, and 0.25 hours pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 36, and 48 hours post-dose.)
  • Change of PR Interval (PR) From Baseline(0.75, 0.5, and 0.25 hours pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 36, and 48 hours post-dose.)

研究者

发起方
Shionogi
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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