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To evaluate the pharmacokinetics safety, and tolerability of single and multiple doses of edaravone solution and suspension in healthy adult males
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A single dose MT-1186 (Part 1, Cohort S1) | Experimental | Healthy Japanese male subjects receive a single dose of MT-1186 or matching placebo. |
|
| A single dose MT-1186 (Part 1, Cohort S2) | Experimental | Healthy Japanese male subjects receive a single dose of MT-1186 or matching placebo. |
|
| A single dose MT-1186 (Part 1, Cohort S3-1) | Experimental | Healthy Japanese male subjects receive doses of MT-1186 or matching placebo. |
|
| A single dose MT-1186 (Part 1, Cohort S3-2) | Experimental | Healthy Japanese male subjects receive doses of MT-1186 or matching placebo. |
|
| A single dose MT-1186 (Part 1, Cohort S4) | Experimental | Healthy Japanese male subjects receive a single dose of MT-1186 or matching placebo. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MT-1186 | Drug | Solution or suspension |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (Aes) and Adverse Drug Reactions (ADRs) | 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 | Area under the plasma concentration versus time curve from time zero up to 24 hours (AUC0-24) of unchanged edaravone. | 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 Sulfate Conjugate | Area under the plasma concentration versus time curve from time zero up to 24 hours (AUC0-24) of sulfate conjugate. | 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 | Area under the plasma concentration versus time curve from time zero up to 24 hours (AUC0-24) of glucuronide conjugate. | 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 Unchanged Edaravone | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Heart Rate (HR) From Baseline | Holter ECG data were recorded in part 1, Cohorts S4, S5, and S6. Baseline is calculated as average HR from 0.75, 0.5, and 0.25 hours pre-dose. | 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 |
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Inclusion Criteria:
Additional screening criteria check may apply for qualification:
Exclusion Criteria:
Additional screening criteria check may apply for qualification:
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| Name | Affiliation | Role |
|---|---|---|
| General Manager | Tanabe Pharma Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site | Osaka | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33704925 | Result | 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. | |
| 36376130 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | A Single Dose MT-1186 (Part 1, Cohort S1) | Healthy Japanese male subjects receive a single dose of MT-1186 60 mg solution. |
| FG001 | A Single Dose MT-1186 (Part 1, Cohort S2) | Healthy Japanese male subjects receive a single dose of MT-1186 120 mg suspension. |
| FG002 | A Single Dose MT-1186 (Part 1, Cohort S3) | Healthy Japanese male subjects receive a single dose of MT-1186 200 mg under fasted condition in period 1, and fed condition in period 2 with washout period at least 4-day. |
| FG003 | A Single Dose MT-1186 (Part 1, Cohort S4) | Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension with xanthan. |
| FG004 | A Single Dose MT-1186 (Part 1, Cohort S5) | Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension. |
| FG005 | A Single Dose MT-1186 (Part 1, Cohort S6) | Healthy Japanese male subjects receive a single dose of MT-1186 30 mg suspension. |
| FG006 | A Single Dose MT-1186 (Part 1, Cohort S7) | Healthy Caucasian male subjects receive a single dose of MT-1186 200 mg suspension. |
| FG007 | Matching Placebo (a Single Dose Cohorts) | Healthy Japanese/Caucasian male subjects receive a single dose of matching placebo. |
| FG008 | Multiple Doses MT-1186 (Part 2, Cohort M1) | Healthy Japanese male subjects receive multiple doses of MT-1186 120 mg suspension. |
| FG009 | Multiple Doses MT-1186 (Part 2, Cohort M2) | Healthy Japanese male subjects receive multiple doses of MT-1186 200 mg suspension. |
| FG010 | Matching Placebo (Multiple Doses Cohorts) | Healthy Japanese male subjects receive multiple doses of matching placebo. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 (Fasted) |
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| Period 2 (After Meal) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | A Single Dose MT-1186 (Part 1, Cohort S1) | Healthy Japanese male subjects receive a single dose of MT-1186 60 mg solution. |
| BG001 | A Single Dose MT-1186 (Part 1, Cohort S2) | Healthy Japanese male subjects receive a single dose of MT-1186 120 mg suspension. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events (Aes) and Adverse Drug Reactions (ADRs) | The trial is divided into 2 phases (a single and multiple-dose). A single-dose study included 8 cohorts (total of 56 subjects), with 42 (6x7) subjects receiving MT-1186, and 14 (2x7) receiving the placebo. Multiple-dose study included 2 cohorts (total of 18 subjects), with 12 (6x2) receiving MT-1186, and 6 (3x2) receiving the placebo for 5 days. Since Cohort S3-1 and S3-2 are crossover cohort, the 5 subjects in Cohort S3-2 are overlapped (total of 79 subjects). | Posted | Count of Participants | Participants | Day 1 to 8 in Part 1, up to 12 days in Part 2 |
|
8 days in part 1, 12 days in part 2
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | A Single Dose MT-1186 (Part 1, Cohort S1) | Healthy Japanese male subjects receive a single dose of MT-1186 60 mg solution. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctivitis | Infections and infestations | MedDRA version 21.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials, Information Desk | Tanabe Pharma Corporation | Please e-mail | cti-inq-ml.JP@ml.tanabe-pharma.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 2, 2018 | May 12, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 9, 2018 | May 12, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000077553 | Edaravone |
| ID | Term |
|---|---|
| D000983 | Antipyrine |
| D047069 | Pyrazolones |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 |
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Single Blind
| A single dose MT-1186 (Part 1, Cohort S5) | Experimental | Healthy Japanese male subjects receive a single dose of MT-1186 or matching placebo. |
|
| A single dose MT-1186 (Part 1, Cohort S6) | Experimental | Healthy Japanese male subjects receive a single dose of MT-1186 or matching placebo. |
|
| A single dose MT-1186 (Part 1, Cohort S7) | Experimental | Healthy Caucasian male subjects receive a single dose of MT-1186 or matching placebo. |
|
| Multiple doses MT-1186 (Part 2, Cohort M1) | Experimental | Healthy Japanese male subjects receive multiple doses of MT-1186 or matching placebo. |
|
| Multiple doses MT-1186 (Part 2, Cohort M2) | Experimental | Healthy Japanese male subjects receive multiple doses of MT-1186 or matching placebo |
|
|
| MT-1186-matching placebo | Drug | Solution or suspension |
|
| Maximum Plasma Concentration (Cmax) of Sulfate Conjugate | 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 Glucuronide Conjugate | 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) | 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 | 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 Sulfate Conjugate | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |
Holter ECG data were recorded in part 1, Cohorts S4, S5, and S6. Baseline is calculated as average HR from 0.75, 0.5, and 0.25 hours pre-dose. |
| 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 QTcF Interval (QTcF) From Baseline | Holter ECG data were recorded in part 1, Cohorts S4, S5, and S6. Baseline is calculated as average HR from 0.75, 0.5, and 0.25 hours pre-dose. | 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 | Holter ECG data were recorded in part 1, Cohorts S4, S5, and S6. | 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. |
| 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. |
| COMPLETED |
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| NOT COMPLETED |
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| BG002 | A Single Dose MT-1186 (Part 1, Cohort S3) | Healthy Japanese male subjects receive a single dose of MT-1186 200 mg under fasted condition in period 1, and fed condition in period 2 with washout period at least 4-day. |
| BG003 | A Single Dose MT-1186 (Part 1, Cohort S4) | Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension with xanthan. |
| BG004 | A Single Dose MT-1186 (Part 1, Cohort S5) | Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension. |
| BG005 | A Single Dose MT-1186 (Part 1, Cohort S6) | Healthy Japanese male subjects receive a single dose of MT-1186 30 mg suspension. |
| BG006 | A Single Dose MT-1186 (Part 1, Cohort S7) | Healthy Caucasian male subjects receive a single dose of MT-1186 200 mg suspension. |
| BG007 | Matching Placebo (a Single Dose Cohorts) | Healthy Japanese/Caucasian male subjects receive a single dose of matching placebo. |
| BG008 | Multiple Doses MT-1186 (Part 2, Cohort M1) | Healthy Japanese male subjects receive multiple doses of MT-1186 120 mg suspension. |
| BG009 | Multiple Doses MT-1186 (Part 2, Cohort M2) | Healthy Japanese male subjects receive multiple doses of MT-1186 200 mg suspension. |
| BG010 | Matching Placebo (Multiple Doses Cohorts) | Healthy Japanese male subjects receive multiple doses of matching placebo. |
| BG011 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S2) |
Healthy Japanese male subjects receive a single dose of MT-1186 120 mg suspension under fasted condition. |
| OG002 | A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S3-1) | Healthy Japanese male subjects receive a single dose of MT-1186 200 mg with fasted condition under period 1. |
| OG003 | A Single Dose MT-1186 Under Fed Condition(Part 1, Cohort S3-2) | Healthy Japanese male subjects receive a single dose of MT-1186 200 mg under fed condition in period 2 with washout period at least 4-day. |
| OG004 | A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S4) | Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension with xanthan under fasted condition. |
| OG005 | A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S5) | Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension under fasted condition. |
| OG006 | A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S6) | Healthy Japanese male subjects receive a single dose of MT-1186 30 mg solution under fasted condition. |
| OG007 | A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S7) | Healthy Caucasian male subjects receive a single dose of MT-1186 200 mg suspension under fasted condition. |
| OG008 | Matching Placebo Under Fasted Condition (a Sngle Dose Cohorts) | Healthy Japanese/Caucasian male subjects receive a single dose of matching placebo. |
| OG009 | Multiple Doses MT-1186 (Part 2, Cohort M1) | Healthy Japanese male subjects receive multiple doses of MT-1186 120 mg suspension under fasted condition. |
| OG010 | Multiple Doses MT-1186 (Part 2, Cohort M2) | Healthy Japanese male subjects receive multiple doses of MT-1186 200 mg suspension under fasted condition. |
| OG011 | Matching Placebo (Multiple Doses Cohorts) | Healthy Japanese male subjects receive multiple doses of matching placebo under fasted condition. |
|
|
| Primary | Area Under the Concentration Versus Time Curve (AUC) of Unchanged Edaravone | Area under the plasma concentration versus time curve from time zero up to 24 hours (AUC0-24) of unchanged edaravone. | The trial is divided into 2 phases (a single and multiple-dose). A single-dose study included 8 cohorts (total of 56 subjects), with 42 (6x7) subjects receiving MT-1186, and 14 (2x7) receiving the placebo. Multiple-dose study included 2 cohorts (total of 18 subjects), with 12 (6x2) receiving MT-1186, and 6 (3x2) receiving the placebo for 5 days. Since Cohort S3-1 and S3-2 are crossover cohort, the 5 subjects in Cohort S3-2 are overlapped (59 patients receiving MT-1186). | Posted | Mean | Standard Deviation | ng*h/mL | 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 |
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| Primary | Area Under the Concentration Versus Time Curve (AUC) of Sulfate Conjugate | Area under the plasma concentration versus time curve from time zero up to 24 hours (AUC0-24) of sulfate conjugate. | The trial is divided into 2 phases (a single and multiple-dose). A single-dose study included 8 cohorts (total of 56 subjects), with 42 (6x7) subjects receiving MT-1186, and 14 (2x7) receiving the placebo. Multiple-dose study included 2 cohorts (total of 18 subjects), with 12 (6x2) receiving MT-1186, and 6 (3x2) receiving the placebo for 5 days. Since Cohort S3-1 and S3-2 are crossover cohort, the 5 subjects in Cohort S3-2 are overlapped (59 patients receiving MT-1186). | Posted | Mean | Standard Deviation | ng*h/mL | 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 |
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| Primary | Area Under the Concentration Versus Time Curve (AUC) of Glucuronide Conjugate | Area under the plasma concentration versus time curve from time zero up to 24 hours (AUC0-24) of glucuronide conjugate. | The trial is divided into 2 phases (a single and multiple-dose). A single-dose study included 8 cohorts (total of 56 subjects), with 42 (6x7) subjects receiving MT-1186, and 14 (2x7) receiving the placebo. Multiple-dose study included 2 cohorts (total of 18 subjects), with 12 (6x2) receiving MT-1186, and 6 (3x2) receiving the placebo for 5 days. Since Cohort S3-1 and S3-2 are crossover cohort, the 5 subjects in Cohort S3-2 are overlapped (59 patients receiving MT-1186). | Posted | Mean | Standard Deviation | ng*h/mL | 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 |
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| Primary | Maximum Plasma Concentration (Cmax) of Unchanged Edaravone | The trial is divided into 2 phases (a single and multiple-dose). A single-dose study included 8 cohorts (total of 56 subjects), with 42 (6x7) subjects receiving MT-1186, and 14 (2x7) receiving the placebo. Multiple-dose study included 2 cohorts (total of 18 subjects), with 12 (6x2) receiving MT-1186, and 6 (3x2) receiving the placebo for 5 days. Since Cohort S3-1 and S3-2 are crossover cohort, the 5 subjects in Cohort S3-2 are overlapped (59 patients receiving MT-1186). | Posted | Mean | Standard Deviation | ng/mL | 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 |
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| Primary | Maximum Plasma Concentration (Cmax) of Sulfate Conjugate | The trial is divided into 2 phases (a single and multiple-dose). A single-dose study included 8 cohorts (total of 56 subjects), with 42 (6x7) subjects receiving MT-1186, and 14 (2x7) receiving the placebo. Multiple-dose study included 2 cohorts (total of 18 subjects), with 12 (6x2) receiving MT-1186, and 6 (3x2) receiving the placebo for 5 days. Since Cohort S3-1 and S3-2 are crossover cohort, the 5 subjects in Cohort S3-2 are overlapped (59 patients receiving MT-1186). | Posted | Mean | Standard Deviation | ng/mL | 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 |
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| Primary | Maximum Plasma Concentration (Cmax) of Glucuronide Conjugate | The trial is divided into 2 phases (a single and multiple-dose). A single-dose study included 8 cohorts (total of 56 subjects), with 42 (6x7) subjects receiving MT-1186, and 14 (2x7) receiving the placebo. Multiple-dose study included 2 cohorts (total of 18 subjects), with 12 (6x2) receiving MT-1186, and 6 (3x2) receiving the placebo for 5 days. Since Cohort S3-1 and S3-2 are crossover cohort, the 5 subjects in Cohort S3-2 are overlapped (59 patients receiving MT-1186). | Posted | Mean | Standard Deviation | ng/mL | 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 |
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| Primary | Part 2: Minimum Plasma Concentration at Steady State (Ctrough, ss) | The trial is divided into 2 phases (a single and multiple-dose). A single-dose study included 8 cohorts (S3-1 and S3-2 are crossover cohort, total of 56 subjects), with 42 (6x7) subjects receiving MT-1186, and 14 (2x7) receiving the placebo. Multiple-dose study included a total of 2 cohorts (total of 18 subjects), with 12 (6x2) receiving MT-1186, and 6 (3x2) receiving the placebo for 5 days. | Posted | Mean | Standard Deviation | ng/mL | 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 |
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| Primary | Time to Reach Maximum Plasma Concentration (Tmax) of Unchanged Edaravone | The trial is divided into 2 phases (a single and multiple-dose). A single-dose study included 8 cohorts (total of 56 subjects), with 42 (6x7) subjects receiving MT-1186, and 14 (2x7) receiving the placebo. Multiple-dose study included 2 cohorts (total of 18 subjects), with 12 (6x2) receiving MT-1186, and 6 (3x2) receiving the placebo for 5 days. Since Cohort S3-1 and S3-2 are crossover cohort, the 5 subjects in Cohort S3-2 are overlapped (59 patients receiving MT-1186). | Posted | Mean | Standard Deviation | h | 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 |
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| Primary | Time to Reach Maximum Plasma Concentration (Tmax) of Sulfate Conjugate | The trial is divided into 2 phases (a single and multiple-dose). A single-dose study included 8 cohorts (total of 56 subjects), with 42 (6x7) subjects receiving MT-1186, and 14 (2x7) receiving the placebo. Multiple-dose study included 2 cohorts (total of 18 subjects), with 12 (6x2) receiving MT-1186, and 6 (3x2) receiving the placebo for 5 days. Since Cohort S3-1 and S3-2 are crossover cohort, the 5 subjects in Cohort S3-2 are overlapped (59 patients receiving MT-1186). | Posted | Mean | Standard Deviation | h | 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 |
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| Primary | Time to Reach Maximum Plasma Concentration (Tmax) of Glucuronide Conjugate | The trial is divided into 2 phases (a single and multiple-dose). A single-dose study included 8 cohorts (total of 56 subjects), with 42 (6x7) subjects receiving MT-1186, and 14 (2x7) receiving the placebo. Multiple-dose study included 2 cohorts (total of 18 subjects), with 12 (6x2) receiving MT-1186, and 6 (3x2) receiving the placebo for 5 days. Since Cohort S3-1 and S3-2 are crossover cohort, the 5 subjects in Cohort S3-2 are overlapped (59 patients receiving MT-1186). | Posted | Mean | Standard Deviation | h | 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 |
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| Primary | Terminal Elimination Half-life (t1/2) of Unchanged Edaravone | The trial is divided into 2 phases (a single and multiple-dose). A single-dose study included 8 cohorts (total of 56 subjects), with 42 (6x7) subjects receiving MT-1186, and 14 (2x7) receiving the placebo. Multiple-dose study included 2 cohorts (total of 18 subjects), with 12 (6x2) receiving MT-1186, and 6 (3x2) receiving the placebo for 5 days. Since Cohort S3-1 and S3-2 are crossover cohort, the 5 subjects in Cohort S3-2 are overlapped (59 patients receiving MT-1186). | Posted | Mean | Standard Deviation | h | 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 |
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| Primary | Terminal Elimination Half-life (t1/2) of Sulfate Conjugate | The trial is divided into 2 phases (a single and multiple-dose). A single-dose study included 8 cohorts (total of 56 subjects), with 42 (6x7) subjects receiving MT-1186, and 14 (2x7) receiving the placebo. Multiple-dose study included 2 cohorts (total of 18 subjects), with 12 (6x2) receiving MT-1186, and 6 (3x2) receiving the placebo for 5 days. Since Cohort S3-1 and S3-2 are crossover cohort, the 5 subjects in Cohort S3-2 are overlapped (59 patients receiving MT-1186). | Posted | Mean | Standard Deviation | h | 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 |
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| Primary | Terminal Elimination Half-life (t1/2) of Glucuronide Conjugate | The trial is divided into 2 phases (a single and multiple-dose). A single-dose study included 8 cohorts (total of 56 subjects), with 42 (6x7) subjects receiving MT-1186, and 14 (2x7) receiving the placebo. Multiple-dose study included 2 cohorts (total of 18 subjects), with 12 (6x2) receiving MT-1186, and 6 (3x2) receiving the placebo for 5 days. Since Cohort S3-1 and S3-2 are crossover cohort, the 5 subjects in Cohort S3-2 are overlapped (59 patients receiving MT-1186). | Posted | Mean | Standard Deviation | h | 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 |
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| Primary | Lambda-z of Unchanged Edaravone | The trial is divided into 2 phases (a single and multiple-dose). A single-dose study included 8 cohorts (total of 56 subjects), with 42 (6x7) subjects receiving MT-1186, and 14 (2x7) receiving the placebo. Multiple-dose study included 2 cohorts (total of 18 subjects), with 12 (6x2) receiving MT-1186, and 6 (3x2) receiving the placebo for 5 days. Since Cohort S3-1 and S3-2 are crossover cohort, the 5 subjects in Cohort S3-2 are overlapped (59 patients receiving MT-1186). | Posted | Mean | Standard Deviation | 1/h | 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 |
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| Primary | Lambda-z of Sulfate Conjugate | The trial is divided into 2 phases (a single and multiple-dose). A single-dose study included 8 cohorts (total of 56 subjects), with 42 (6x7) subjects receiving MT-1186, and 14 (2x7) receiving the placebo. Multiple-dose study included 2 cohorts (total of 18 subjects), with 12 (6x2) receiving MT-1186, and 6 (3x2) receiving the placebo for 5 days. Since Cohort S3-1 and S3-2 are crossover cohort, the 5 subjects in Cohort S3-2 are overlapped (59 patients receiving MT-1186). | Posted | Mean | Standard Deviation | 1/h | 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 |
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| Primary | Lambda-z of Glucuronide Conjugate | The trial is divided into 2 phases (a single and multiple-dose). A single-dose study included 8 cohorts (total of 56 subjects), with 42 (6x7) subjects receiving MT-1186, and 14 (2x7) receiving the placebo. Multiple-dose study included 2 cohorts (total of 18 subjects), with 12 (6x2) receiving MT-1186, and 6 (3x2) receiving the placebo for 5 days. Since Cohort S3-1 and S3-2 are crossover cohort, the 5 subjects in Cohort S3-2 are overlapped (59 patients receiving MT-1186). | Posted | Mean | Standard Deviation | 1/h | 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 |
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| Primary | Mean Residence Time (MRT) of Unchanged Edaravone | The trial is divided into 2 phases (a single and multiple-dose). A single-dose study included 8 cohorts (total of 56 subjects), with 42 (6x7) subjects receiving MT-1186, and 14 (2x7) receiving the placebo. Multiple-dose study included 2 cohorts (total of 18 subjects), with 12 (6x2) receiving MT-1186, and 6 (3x2) receiving the placebo for 5 days. Since Cohort S3-1 and S3-2 are crossover cohort, the 5 subjects in Cohort S3-2 are overlapped (59 patients receiving MT-1186). | Posted | Mean | Standard Deviation | h | 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 |
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| Primary | Apparent Total Clearance (CL/F) of Unchanged Edaravone | The trial is divided into 2 phases (a single and multiple-dose). A single-dose study included 8 cohorts (total of 56 subjects), with 42 (6x7) subjects receiving MT-1186, and 14 (2x7) receiving the placebo. Multiple-dose study included 2 cohorts (total of 18 subjects), with 12 (6x2) receiving MT-1186, and 6 (3x2) receiving the placebo for 5 days. Since Cohort S3-1 and S3-2 are crossover cohort, the 5 subjects in Cohort S3-2 are overlapped (59 patients receiving MT-1186). | Posted | Mean | Standard Deviation | L/h | 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 |
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| Primary | Apparent Distribution Volume at Elimination Phase (Vz/F) and Apparent Distribution Volume at Steady State (Vss/F) of Unchanged Edaravone | The trial is divided into 2 phases (a single and multiple-dose). A single-dose study included 8 cohorts (total of 56 subjects), with 42 (6x7) subjects receiving MT-1186, and 14 (2x7) receiving the placebo. Multiple-dose study included 2 cohorts (total of 18 subjects), with 12 (6x2) receiving MT-1186, and 6 (3x2) receiving the placebo for 5 days. Since Cohort S3-1 and S3-2 are crossover cohort, the 5 subjects in Cohort S3-2 are overlapped (59 patients receiving MT-1186). | Posted | Mean | Standard Deviation | L | 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 |
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| Secondary | Change of Heart Rate (HR) From Baseline | Holter ECG data were recorded in part 1, Cohorts S4, S5, and S6. Baseline is calculated as average HR from 0.75, 0.5, and 0.25 hours pre-dose. | Pharmacodynamic data were collected in Cohort S4, S5 and S6 with 18 (6x3 subjects receiving MT-1186), and 6 (2x3) receiving the placebo of Part 1. | Posted | Least Squares Mean | Standard Error | bpm | 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. |
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| Secondary | Change of PR Interval (PR) From Baseline | Holter ECG data were recorded in part 1, Cohorts S4, S5, and S6. Baseline is calculated as average HR from 0.75, 0.5, and 0.25 hours pre-dose. | Pharmacodynamic data were collected in Cohort S4, S5 and S6 with 18 (6x3 subjects receiving MT-1186), and 6 (2x3) receiving the placebo of Part 1. | Posted | Least Squares Mean | Standard Error | msec | 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. |
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| Secondary | Change of QTcF Interval (QTcF) From Baseline | Holter ECG data were recorded in part 1, Cohorts S4, S5, and S6. Baseline is calculated as average HR from 0.75, 0.5, and 0.25 hours pre-dose. | Pharmacodynamic data were collected in Cohort S4, S5 and S6 with 18 (6x3 subjects receiving MT-1186), and 6 (2x3) receiving the placebo of Part 1. | Posted | Least Squares Mean | Standard Error | msec | 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. |
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| Secondary | Change of QRS Duration (QRS) From Baseline | Holter ECG data were recorded in part 1, Cohorts S4, S5, and S6. | Pharmacodynamic data were collected in Cohort S4, S5 and S6 with 18 (6x3 subjects receiving MT-1186), and 6 (2x3) receiving the placebo of Part 1. | Posted | Least Squares Mean | Standard Error | msec | 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. |
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| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | A Single Dose MT-1186 (Part 1, Cohort S2) | Healthy Japanese male subjects receive a single dose of MT-1186 120 mg suspension. | 0 | 6 | 0 | 6 | 2 | 6 |
| EG002 | A Single Dose MT-1186 (Part 1, Cohort S3) | Healthy Japanese male subjects receive a single dose of MT-1186 200 mg under fasted condition in period 1, and fed condition in period 2 with washout period at least 4-day. | 0 | 6 | 0 | 6 | 3 | 6 |
| EG003 | A Single Dose MT-1186 (Part 1, Cohort S4) | Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension with xanthan. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG004 | A Single Dose MT-1186 (Part 1, Cohort S5) | Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG005 | A Single Dose MT-1186 (Part 1, Cohort S6) | Healthy Japanese male subjects receive a single dose of MT-1186 30 mg suspension. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG006 | A Single Dose MT-1186 (Part 1, Cohort S7) | Healthy Caucasian male subjects receive a single dose of MT-1186 200 mg suspension. | 0 | 6 | 0 | 6 | 2 | 6 |
| EG007 | Matching Placebo (a Single Dose Cohorts) | Healthy Japanese/Caucasian male subjects receive a single dose of matching placebo. | 0 | 14 | 0 | 14 | 2 | 14 |
| EG008 | Multiple Doses MT-1186 (Part 2, Cohort M1) | Healthy Japanese male subjects receive multiple doses of MT-1186 120 mg suspension. | 0 | 6 | 0 | 6 | 2 | 6 |
| EG009 | Multiple Doses MT-1186 (Part 2, Cohort M2) | Healthy Japanese male subjects receive multiple doses of MT-1186 200 mg suspension. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG010 | Matching Placebo (Multiple Doses Cohorts) | Healthy Japanese male subjects receive multiple doses of matching placebo. | 0 | 6 | 0 | 6 | 1 | 6 |
| Nasopharyngitis | Infections and infestations | MedDRA version 21.0 | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA version 21.0 | Systematic Assessment |
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| Dizziness postural | Nervous system disorders | MedDRA version 21.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA version 21.0 | Systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA version 21.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA version 21.0 | Systematic Assessment |
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| Enterocolitis | Gastrointestinal disorders | MedDRA version 21.0 | Systematic Assessment |
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| Hepatic function abnormal | Hepatobiliary disorders | MedDRA version 21.0 | Systematic Assessment |
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| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA version 21.0 | Systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedDRA version 21.0 | Systematic Assessment |
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| Blood glucose increased | Investigations | MedDRA version 21.0 | Systematic Assessment |
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| Blood uric acid increased | Investigations | MedDRA version 21.0 | Systematic Assessment |
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| Blood urine present | Investigations | MedDRA version 21.0 | Systematic Assessment |
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| White blood cell count increased | Investigations | MedDRA version 21.0 | Systematic Assessment |
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| Protein urine present | Investigations | MedDRA version 21.0 | Systematic Assessment |
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Not provided
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| AUC from time zero to 24 hour (AUC 0-24): Day 5, only Part 2 |
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| AUC from time zero to 24 hour (AUC 0-24): Day 5, only part 2 |
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