Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
74 participants
INTERVENTIONAL
2018-03-20
2018-08-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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A single dose MT-1186 (Part 1, Cohort S1)
Healthy Japanese male subjects receive a single dose of MT-1186 or matching placebo.
MT-1186
Solution or suspension
MT-1186-matching placebo
Solution or suspension
A single dose MT-1186 (Part 1, Cohort S2)
Healthy Japanese male subjects receive a single dose of MT-1186 or matching placebo.
MT-1186
Solution or suspension
MT-1186-matching placebo
Solution or suspension
A single dose MT-1186 (Part 1, Cohort S3-1)
Healthy Japanese male subjects receive doses of MT-1186 or matching placebo.
MT-1186
Solution or suspension
MT-1186-matching placebo
Solution or suspension
A single dose MT-1186 (Part 1, Cohort S3-2)
Healthy Japanese male subjects receive doses of MT-1186 or matching placebo.
MT-1186
Solution or suspension
MT-1186-matching placebo
Solution or suspension
A single dose MT-1186 (Part 1, Cohort S4)
Healthy Japanese male subjects receive a single dose of MT-1186 or matching placebo.
MT-1186
Solution or suspension
MT-1186-matching placebo
Solution or suspension
A single dose MT-1186 (Part 1, Cohort S5)
Healthy Japanese male subjects receive a single dose of MT-1186 or matching placebo.
MT-1186
Solution or suspension
MT-1186-matching placebo
Solution or suspension
A single dose MT-1186 (Part 1, Cohort S6)
Healthy Japanese male subjects receive a single dose of MT-1186 or matching placebo.
MT-1186
Solution or suspension
MT-1186-matching placebo
Solution or suspension
A single dose MT-1186 (Part 1, Cohort S7)
Healthy Caucasian male subjects receive a single dose of MT-1186 or matching placebo.
MT-1186
Solution or suspension
MT-1186-matching placebo
Solution or suspension
Multiple doses MT-1186 (Part 2, Cohort M1)
Healthy Japanese male subjects receive multiple doses of MT-1186 or matching placebo.
MT-1186
Solution or suspension
MT-1186-matching placebo
Solution or suspension
Multiple doses MT-1186 (Part 2, Cohort M2)
Healthy Japanese male subjects receive multiple doses of MT-1186 or matching placebo
MT-1186
Solution or suspension
MT-1186-matching placebo
Solution or suspension
Interventions
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MT-1186
Solution or suspension
MT-1186-matching placebo
Solution or suspension
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
20 Years
45 Years
MALE
Yes
Sponsors
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Tanabe Pharma Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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General Manager
Role: STUDY_DIRECTOR
Tanabe Pharma Corporation
Locations
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Investigational Site
Osaka, , Japan
Countries
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References
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Shimizu H, Nishimura Y, Shiide Y, Matsuda H, Akimoto M, Matsuda M, Nakamaru Y, Kato Y, Kondo K. Evaluation of Pharmacokinetics, Safety, and Drug-Drug Interactions of an Oral Suspension of Edaravone in Healthy Adults. Clin Pharmacol Drug Dev. 2021 Oct;10(10):1174-1187. doi: 10.1002/cpdd.925. Epub 2021 Mar 11.
Shimizu H, Nishimura Y, Shiide Y, Akimoto M, Matsuda H, Kato Y, Hirai M. Food Effect Study to Assess the Impact on Edaravone Pharmacokinetic Profiles in Healthy Participants. Clin Ther. 2022 Dec;44(12):1552-1565. doi: 10.1016/j.clinthera.2022.10.001. Epub 2022 Nov 12.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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MT-1186-J01
Identifier Type: -
Identifier Source: org_study_id
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