Trial Outcomes & Findings for Study of Oral Edaravone in Healthy Adult Males (NCT NCT04481750)
NCT ID: NCT04481750
Last Updated: 2026-01-07
Results Overview
COMPLETED
PHASE1
74 participants
Day 1 to 8 in Part 1, up to 12 days in Part 2
2026-01-07
Participant Flow
Participant milestones
| Measure |
A Single Dose MT-1186 (Part 1, Cohort S1)
Healthy Japanese male subjects receive a single dose of MT-1186 60 mg solution.
|
A Single Dose MT-1186 (Part 1, Cohort S2)
Healthy Japanese male subjects receive a single dose of MT-1186 120 mg suspension.
|
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.
|
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.
|
A Single Dose MT-1186 (Part 1, Cohort S5)
Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension.
|
A Single Dose MT-1186 (Part 1, Cohort S6)
Healthy Japanese male subjects receive a single dose of MT-1186 30 mg suspension.
|
A Single Dose MT-1186 (Part 1, Cohort S7)
Healthy Caucasian male subjects receive a single dose of MT-1186 200 mg suspension.
|
Matching Placebo (a Single Dose Cohorts)
Healthy Japanese/Caucasian male subjects receive a single dose of matching placebo.
|
Multiple Doses MT-1186 (Part 2, Cohort M1)
Healthy Japanese male subjects receive multiple doses of MT-1186 120 mg suspension.
|
Multiple Doses MT-1186 (Part 2, Cohort M2)
Healthy Japanese male subjects receive multiple doses of MT-1186 200 mg suspension.
|
Matching Placebo (Multiple Doses Cohorts)
Healthy Japanese male subjects receive multiple doses of matching placebo.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Period 1 (Fasted)
STARTED
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
14
|
6
|
6
|
6
|
|
Period 1 (Fasted)
COMPLETED
|
6
|
6
|
5
|
6
|
6
|
6
|
6
|
14
|
6
|
6
|
6
|
|
Period 1 (Fasted)
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 2 (After Meal)
STARTED
|
0
|
0
|
5
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 2 (After Meal)
COMPLETED
|
0
|
0
|
5
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 2 (After Meal)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
A Single Dose MT-1186 (Part 1, Cohort S1)
Healthy Japanese male subjects receive a single dose of MT-1186 60 mg solution.
|
A Single Dose MT-1186 (Part 1, Cohort S2)
Healthy Japanese male subjects receive a single dose of MT-1186 120 mg suspension.
|
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.
|
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.
|
A Single Dose MT-1186 (Part 1, Cohort S5)
Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension.
|
A Single Dose MT-1186 (Part 1, Cohort S6)
Healthy Japanese male subjects receive a single dose of MT-1186 30 mg suspension.
|
A Single Dose MT-1186 (Part 1, Cohort S7)
Healthy Caucasian male subjects receive a single dose of MT-1186 200 mg suspension.
|
Matching Placebo (a Single Dose Cohorts)
Healthy Japanese/Caucasian male subjects receive a single dose of matching placebo.
|
Multiple Doses MT-1186 (Part 2, Cohort M1)
Healthy Japanese male subjects receive multiple doses of MT-1186 120 mg suspension.
|
Multiple Doses MT-1186 (Part 2, Cohort M2)
Healthy Japanese male subjects receive multiple doses of MT-1186 200 mg suspension.
|
Matching Placebo (Multiple Doses Cohorts)
Healthy Japanese male subjects receive multiple doses of matching placebo.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Period 1 (Fasted)
Adverse Event
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Study of Oral Edaravone in Healthy Adult Males
Baseline characteristics by cohort
| Measure |
A Single Dose MT-1186 (Part 1, Cohort S1)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 60 mg solution.
|
A Single Dose MT-1186 (Part 1, Cohort S2)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 120 mg suspension.
|
A Single Dose MT-1186 (Part 1, Cohort S3)
n=6 Participants
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.
|
A Single Dose MT-1186 (Part 1, Cohort S4)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension with xanthan.
|
A Single Dose MT-1186 (Part 1, Cohort S5)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension.
|
A Single Dose MT-1186 (Part 1, Cohort S6)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 30 mg suspension.
|
A Single Dose MT-1186 (Part 1, Cohort S7)
n=6 Participants
Healthy Caucasian male subjects receive a single dose of MT-1186 200 mg suspension.
|
Matching Placebo (a Single Dose Cohorts)
n=14 Participants
Healthy Japanese/Caucasian male subjects receive a single dose of matching placebo.
|
Multiple Doses MT-1186 (Part 2, Cohort M1)
n=6 Participants
Healthy Japanese male subjects receive multiple doses of MT-1186 120 mg suspension.
|
Multiple Doses MT-1186 (Part 2, Cohort M2)
n=6 Participants
Healthy Japanese male subjects receive multiple doses of MT-1186 200 mg suspension.
|
Matching Placebo (Multiple Doses Cohorts)
n=6 Participants
Healthy Japanese male subjects receive multiple doses of matching placebo.
|
Total
n=74 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=61 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=80 Participants
|
0 Participants
n=81 Participants
|
0 Participants
n=81 Participants
|
0 Participants
n=80 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=37 Participants
|
6 Participants
n=56 Participants
|
6 Participants
n=95 Participants
|
6 Participants
n=61 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=25 Participants
|
6 Participants
n=30 Participants
|
14 Participants
n=82 Participants
|
6 Participants
n=80 Participants
|
6 Participants
n=81 Participants
|
6 Participants
n=81 Participants
|
74 Participants
n=80 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=61 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=80 Participants
|
0 Participants
n=81 Participants
|
0 Participants
n=81 Participants
|
0 Participants
n=80 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=61 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=80 Participants
|
0 Participants
n=81 Participants
|
0 Participants
n=81 Participants
|
0 Participants
n=80 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=37 Participants
|
6 Participants
n=56 Participants
|
6 Participants
n=95 Participants
|
6 Participants
n=61 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=25 Participants
|
6 Participants
n=30 Participants
|
14 Participants
n=82 Participants
|
6 Participants
n=80 Participants
|
6 Participants
n=81 Participants
|
6 Participants
n=81 Participants
|
74 Participants
n=80 Participants
|
|
Race/Ethnicity, Customized
White
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=61 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=25 Participants
|
6 Participants
n=30 Participants
|
2 Participants
n=82 Participants
|
0 Participants
n=80 Participants
|
0 Participants
n=81 Participants
|
0 Participants
n=81 Participants
|
8 Participants
n=80 Participants
|
|
Race/Ethnicity, Customized
Asian (Japanese)
|
6 Participants
n=37 Participants
|
6 Participants
n=56 Participants
|
6 Participants
n=95 Participants
|
6 Participants
n=61 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=25 Participants
|
0 Participants
n=30 Participants
|
12 Participants
n=82 Participants
|
6 Participants
n=80 Participants
|
6 Participants
n=81 Participants
|
6 Participants
n=81 Participants
|
66 Participants
n=80 Participants
|
PRIMARY outcome
Timeframe: Day 1 to 8 in Part 1, up to 12 days in Part 2Population: 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).
Outcome measures
| Measure |
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S1)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 60 mg solution under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S2)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 120 mg suspension under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S3-1)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 200 mg with fasted condition under period 1.
|
A Single Dose MT-1186 Under Fed Condition(Part 1, Cohort S3-2)
n=5 Participants
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.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S4)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension with xanthan under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S5)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S6)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 30 mg solution under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S7)
n=6 Participants
Healthy Caucasian male subjects receive a single dose of MT-1186 200 mg suspension under fasted condition.
|
Matching Placebo Under Fasted Condition (a Sngle Dose Cohorts)
n=14 Participants
Healthy Japanese/Caucasian male subjects receive a single dose of matching placebo.
|
Multiple Doses MT-1186 (Part 2, Cohort M1)
n=6 Participants
Healthy Japanese male subjects receive multiple doses of MT-1186 120 mg suspension under fasted condition.
|
Multiple Doses MT-1186 (Part 2, Cohort M2)
n=6 Participants
Healthy Japanese male subjects receive multiple doses of MT-1186 200 mg suspension under fasted condition.
|
Matching Placebo (Multiple Doses Cohorts)
n=6 Participants
Healthy Japanese male subjects receive multiple doses of matching placebo under fasted condition.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (Aes) and Adverse Drug Reactions (ADRs)
Participants with AEs
|
0 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events (Aes) and Adverse Drug Reactions (ADRs)
Participants with ADRs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 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 5Population: 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).
Area under the plasma concentration versus time curve from time zero up to 24 hours (AUC0-24) of unchanged edaravone.
Outcome measures
| Measure |
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S1)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 60 mg solution under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S2)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 120 mg suspension under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S3-1)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 200 mg with fasted condition under period 1.
|
A Single Dose MT-1186 Under Fed Condition(Part 1, Cohort S3-2)
n=5 Participants
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.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S4)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension with xanthan under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S5)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S6)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 30 mg solution under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S7)
n=6 Participants
Healthy Caucasian male subjects receive a single dose of MT-1186 200 mg suspension under fasted condition.
|
Matching Placebo Under Fasted Condition (a Sngle Dose Cohorts)
n=6 Participants
Healthy Japanese/Caucasian male subjects receive a single dose of matching placebo.
|
Multiple Doses MT-1186 (Part 2, Cohort M1)
n=6 Participants
Healthy Japanese male subjects receive multiple doses of MT-1186 120 mg suspension under fasted condition.
|
Multiple Doses MT-1186 (Part 2, Cohort M2)
Healthy Japanese male subjects receive multiple doses of MT-1186 200 mg suspension under fasted condition.
|
Matching Placebo (Multiple Doses Cohorts)
Healthy Japanese male subjects receive multiple doses of matching placebo under fasted condition.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration Versus Time Curve (AUC) of Unchanged Edaravone
AUC from time zero to 24 hour (AUC 0-24): Day 1
|
816 ng*h/mL
Standard Deviation 231
|
2242 ng*h/mL
Standard Deviation 911
|
6254 ng*h/mL
Standard Deviation 1236
|
2443 ng*h/mL
Standard Deviation 813
|
11319 ng*h/mL
Standard Deviation 1053
|
9034 ng*h/mL
Standard Deviation 2738
|
285 ng*h/mL
Standard Deviation 113
|
4935 ng*h/mL
Standard Deviation 1980
|
1917 ng*h/mL
Standard Deviation 383
|
4133 ng*h/mL
Standard Deviation 1260
|
—
|
—
|
|
Area Under the Concentration Versus Time Curve (AUC) of Unchanged Edaravone
AUC from time zero to 24 hour (AUC 0-24): Day 5, only Part 2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
2189 ng*h/mL
Standard Deviation 516
|
4279 ng*h/mL
Standard Deviation 1166
|
—
|
—
|
PRIMARY outcome
Timeframe: 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 5Population: 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).
Area under the plasma concentration versus time curve from time zero up to 24 hours (AUC0-24) of sulfate conjugate.
Outcome measures
| Measure |
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S1)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 60 mg solution under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S2)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 120 mg suspension under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S3-1)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 200 mg with fasted condition under period 1.
|
A Single Dose MT-1186 Under Fed Condition(Part 1, Cohort S3-2)
n=5 Participants
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.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S4)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension with xanthan under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S5)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S6)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 30 mg solution under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S7)
n=6 Participants
Healthy Caucasian male subjects receive a single dose of MT-1186 200 mg suspension under fasted condition.
|
Matching Placebo Under Fasted Condition (a Sngle Dose Cohorts)
n=6 Participants
Healthy Japanese/Caucasian male subjects receive a single dose of matching placebo.
|
Multiple Doses MT-1186 (Part 2, Cohort M1)
n=6 Participants
Healthy Japanese male subjects receive multiple doses of MT-1186 120 mg suspension under fasted condition.
|
Multiple Doses MT-1186 (Part 2, Cohort M2)
Healthy Japanese male subjects receive multiple doses of MT-1186 200 mg suspension under fasted condition.
|
Matching Placebo (Multiple Doses Cohorts)
Healthy Japanese male subjects receive multiple doses of matching placebo under fasted condition.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration Versus Time Curve (AUC) of Sulfate Conjugate
AUC from time zero to 24 hour (AUC 0-24): Day 1
|
16251 ng*h/mL
Standard Deviation 7143
|
30004 ng*h/mL
Standard Deviation 6103
|
45666 ng*h/mL
Standard Deviation 10447
|
38244 ng*h/mL
Standard Deviation 4602
|
67693 ng*h/mL
Standard Deviation 14170
|
68126 ng*h/mL
Standard Deviation 15067
|
6709 ng*h/mL
Standard Deviation 2171
|
44797 ng*h/mL
Standard Deviation 16374
|
26132 ng*h/mL
Standard Deviation 4083
|
39516 ng*h/mL
Standard Deviation 3331
|
—
|
—
|
|
Area Under the Concentration Versus Time Curve (AUC) of Sulfate Conjugate
AUC from time zero to 24 hour (AUC 0-24): Day 5, only part 2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
24578 ng*h/mL
Standard Deviation 4186
|
39102 ng*h/mL
Standard Deviation 4208
|
—
|
—
|
PRIMARY outcome
Timeframe: 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 5Population: 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).
Area under the plasma concentration versus time curve from time zero up to 24 hours (AUC0-24) of glucuronide conjugate.
Outcome measures
| Measure |
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S1)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 60 mg solution under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S2)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 120 mg suspension under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S3-1)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 200 mg with fasted condition under period 1.
|
A Single Dose MT-1186 Under Fed Condition(Part 1, Cohort S3-2)
n=5 Participants
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.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S4)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension with xanthan under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S5)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S6)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 30 mg solution under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S7)
n=6 Participants
Healthy Caucasian male subjects receive a single dose of MT-1186 200 mg suspension under fasted condition.
|
Matching Placebo Under Fasted Condition (a Sngle Dose Cohorts)
n=6 Participants
Healthy Japanese/Caucasian male subjects receive a single dose of matching placebo.
|
Multiple Doses MT-1186 (Part 2, Cohort M1)
n=6 Participants
Healthy Japanese male subjects receive multiple doses of MT-1186 120 mg suspension under fasted condition.
|
Multiple Doses MT-1186 (Part 2, Cohort M2)
Healthy Japanese male subjects receive multiple doses of MT-1186 200 mg suspension under fasted condition.
|
Matching Placebo (Multiple Doses Cohorts)
Healthy Japanese male subjects receive multiple doses of matching placebo under fasted condition.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration Versus Time Curve (AUC) of Glucuronide Conjugate
AUC from time zero to 24 hour (AUC 0-24):Day 1
|
2360 ng*h/mL
Standard Deviation 648
|
4815 ng*h/mL
Standard Deviation 910
|
8146 ng*h/mL
Standard Deviation 1275
|
7406 ng*h/mL
Standard Deviation 1368
|
14403 ng*h/mL
Standard Deviation 1557
|
12499 ng*h/mL
Standard Deviation 3457
|
1201 ng*h/mL
Standard Deviation 454
|
8038 ng*h/mL
Standard Deviation 1898
|
4806 ng*h/mL
Standard Deviation 509
|
7932 ng*h/mL
Standard Deviation 1190
|
—
|
—
|
|
Area Under the Concentration Versus Time Curve (AUC) of Glucuronide Conjugate
AUC from time zero to 24 hour (AUC 0-24): Day 5, only part 2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
4698 ng*h/mL
Standard Deviation 499
|
8059 ng*h/mL
Standard Deviation 1278
|
—
|
—
|
PRIMARY outcome
Timeframe: 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 5Population: 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).
Outcome measures
| Measure |
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S1)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 60 mg solution under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S2)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 120 mg suspension under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S3-1)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 200 mg with fasted condition under period 1.
|
A Single Dose MT-1186 Under Fed Condition(Part 1, Cohort S3-2)
n=5 Participants
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.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S4)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension with xanthan under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S5)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S6)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 30 mg solution under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S7)
n=6 Participants
Healthy Caucasian male subjects receive a single dose of MT-1186 200 mg suspension under fasted condition.
|
Matching Placebo Under Fasted Condition (a Sngle Dose Cohorts)
n=6 Participants
Healthy Japanese/Caucasian male subjects receive a single dose of matching placebo.
|
Multiple Doses MT-1186 (Part 2, Cohort M1)
n=6 Participants
Healthy Japanese male subjects receive multiple doses of MT-1186 120 mg suspension under fasted condition.
|
Multiple Doses MT-1186 (Part 2, Cohort M2)
Healthy Japanese male subjects receive multiple doses of MT-1186 200 mg suspension under fasted condition.
|
Matching Placebo (Multiple Doses Cohorts)
Healthy Japanese male subjects receive multiple doses of matching placebo under fasted condition.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of Unchanged Edaravone
Day 1
|
755 ng/mL
Standard Deviation 356
|
1735 ng/mL
Standard Deviation 738
|
4933 ng/mL
Standard Deviation 1268
|
899 ng/mL
Standard Deviation 464
|
8805 ng/mL
Standard Deviation 933
|
5426 ng/mL
Standard Deviation 2496
|
208 ng/mL
Standard Deviation 112
|
3692 ng/mL
Standard Deviation 1529
|
1953 ng/mL
Standard Deviation 838
|
3855 ng/mL
Standard Deviation 1676
|
—
|
—
|
|
Maximum Plasma Concentration (Cmax) of Unchanged Edaravone
Day 5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
2308 ng/mL
Standard Deviation 941
|
4092 ng/mL
Standard Deviation 1715
|
—
|
—
|
PRIMARY outcome
Timeframe: 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 5Population: 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).
Outcome measures
| Measure |
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S1)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 60 mg solution under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S2)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 120 mg suspension under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S3-1)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 200 mg with fasted condition under period 1.
|
A Single Dose MT-1186 Under Fed Condition(Part 1, Cohort S3-2)
n=5 Participants
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.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S4)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension with xanthan under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S5)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S6)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 30 mg solution under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S7)
n=6 Participants
Healthy Caucasian male subjects receive a single dose of MT-1186 200 mg suspension under fasted condition.
|
Matching Placebo Under Fasted Condition (a Sngle Dose Cohorts)
n=6 Participants
Healthy Japanese/Caucasian male subjects receive a single dose of matching placebo.
|
Multiple Doses MT-1186 (Part 2, Cohort M1)
n=6 Participants
Healthy Japanese male subjects receive multiple doses of MT-1186 120 mg suspension under fasted condition.
|
Multiple Doses MT-1186 (Part 2, Cohort M2)
Healthy Japanese male subjects receive multiple doses of MT-1186 200 mg suspension under fasted condition.
|
Matching Placebo (Multiple Doses Cohorts)
Healthy Japanese male subjects receive multiple doses of matching placebo under fasted condition.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of Sulfate Conjugate
Day 1
|
5481 ng/mL
Standard Deviation 2337
|
9108 ng/mL
Standard Deviation 2104
|
12190 ng/mL
Standard Deviation 2087
|
7324 ng/mL
Standard Deviation 743
|
14590 ng/mL
Standard Deviation 2102
|
14080 ng/mL
Standard Deviation 4787
|
2913 ng/mL
Standard Deviation 870
|
11510 ng/mL
Standard Deviation 2502
|
7318 ng/mL
Standard Deviation 612
|
10830 ng/mL
Standard Deviation 2346
|
—
|
—
|
|
Maximum Plasma Concentration (Cmax) of Sulfate Conjugate
Day 5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
7402 ng/mL
Standard Deviation 954
|
11200 ng/mL
Standard Deviation 1744
|
—
|
—
|
PRIMARY outcome
Timeframe: 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 5Population: 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).
Outcome measures
| Measure |
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S1)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 60 mg solution under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S2)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 120 mg suspension under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S3-1)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 200 mg with fasted condition under period 1.
|
A Single Dose MT-1186 Under Fed Condition(Part 1, Cohort S3-2)
n=5 Participants
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.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S4)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension with xanthan under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S5)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S6)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 30 mg solution under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S7)
n=6 Participants
Healthy Caucasian male subjects receive a single dose of MT-1186 200 mg suspension under fasted condition.
|
Matching Placebo Under Fasted Condition (a Sngle Dose Cohorts)
n=6 Participants
Healthy Japanese/Caucasian male subjects receive a single dose of matching placebo.
|
Multiple Doses MT-1186 (Part 2, Cohort M1)
n=6 Participants
Healthy Japanese male subjects receive multiple doses of MT-1186 120 mg suspension under fasted condition.
|
Multiple Doses MT-1186 (Part 2, Cohort M2)
Healthy Japanese male subjects receive multiple doses of MT-1186 200 mg suspension under fasted condition.
|
Matching Placebo (Multiple Doses Cohorts)
Healthy Japanese male subjects receive multiple doses of matching placebo under fasted condition.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of Glucuronide Conjugate
Day 1
|
1313 ng/mL
Standard Deviation 378
|
2272 ng/mL
Standard Deviation 279
|
3507 ng/mL
Standard Deviation 158
|
1893 ng/mL
Standard Deviation 358
|
5322 ng/mL
Standard Deviation 958
|
3968 ng/mL
Standard Deviation 912
|
750 ng/mL
Standard Deviation 263
|
3361 ng/mL
Standard Deviation 1183
|
2145 ng/mL
Standard Deviation 356
|
3219 ng/mL
Standard Deviation 666
|
—
|
—
|
|
Maximum Plasma Concentration (Cmax) of Glucuronide Conjugate
Day 5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
2209 ng/mL
Standard Deviation 156
|
3439 ng/mL
Standard Deviation 428
|
—
|
—
|
PRIMARY outcome
Timeframe: 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 5Population: 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.
Outcome measures
| Measure |
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S1)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 60 mg solution under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S2)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 120 mg suspension under fasted condition.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
Matching Placebo Under Fasted Condition (a Sngle Dose Cohorts)
Healthy Japanese/Caucasian male subjects receive a single dose of matching placebo.
|
Multiple Doses MT-1186 (Part 2, Cohort M1)
Healthy Japanese male subjects receive multiple doses of MT-1186 120 mg suspension under fasted condition.
|
Multiple Doses MT-1186 (Part 2, Cohort M2)
Healthy Japanese male subjects receive multiple doses of MT-1186 200 mg suspension under fasted condition.
|
Matching Placebo (Multiple Doses Cohorts)
Healthy Japanese male subjects receive multiple doses of matching placebo under fasted condition.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Minimum Plasma Concentration at Steady State (Ctrough, ss)
Unchanged Edaravone
|
2.34 ng/mL
Standard Deviation 0.30
|
3.79 ng/mL
Standard Deviation 0.80
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Minimum Plasma Concentration at Steady State (Ctrough, ss)
Sulfate conjugate
|
32.91 ng/mL
Standard Deviation 9.01
|
49.98 ng/mL
Standard Deviation 11.22
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Minimum Plasma Concentration at Steady State (Ctrough, ss)
Glucuronide conjugate
|
2.69 ng/mL
Standard Deviation 0.30
|
5.48 ng/mL
Standard Deviation 1.90
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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 5Population: 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).
Outcome measures
| Measure |
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S1)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 60 mg solution under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S2)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 120 mg suspension under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S3-1)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 200 mg with fasted condition under period 1.
|
A Single Dose MT-1186 Under Fed Condition(Part 1, Cohort S3-2)
n=5 Participants
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.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S4)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension with xanthan under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S5)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S6)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 30 mg solution under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S7)
n=6 Participants
Healthy Caucasian male subjects receive a single dose of MT-1186 200 mg suspension under fasted condition.
|
Matching Placebo Under Fasted Condition (a Sngle Dose Cohorts)
n=6 Participants
Healthy Japanese/Caucasian male subjects receive a single dose of matching placebo.
|
Multiple Doses MT-1186 (Part 2, Cohort M1)
n=6 Participants
Healthy Japanese male subjects receive multiple doses of MT-1186 120 mg suspension under fasted condition.
|
Multiple Doses MT-1186 (Part 2, Cohort M2)
Healthy Japanese male subjects receive multiple doses of MT-1186 200 mg suspension under fasted condition.
|
Matching Placebo (Multiple Doses Cohorts)
Healthy Japanese male subjects receive multiple doses of matching placebo under fasted condition.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Reach Maximum Plasma Concentration (Tmax) of Unchanged Edaravone
Day 1
|
0.3 h
Standard Deviation 0.1
|
0.4 h
Standard Deviation 0.1
|
0.4 h
Standard Deviation 0.1
|
1.4 h
Standard Deviation 1.6
|
0.6 h
Standard Deviation 0.3
|
0.8 h
Standard Deviation 0.4
|
0.4 h
Standard Deviation 0.1
|
0.6 h
Standard Deviation 0.3
|
0.4 h
Standard Deviation 0.1
|
0.4 h
Standard Deviation 0.1
|
—
|
—
|
|
Time to Reach Maximum Plasma Concentration (Tmax) of Unchanged Edaravone
Day 5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.4 h
Standard Deviation 0.1
|
0.4 h
Standard Deviation 0.1
|
—
|
—
|
PRIMARY outcome
Timeframe: 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 5Population: 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).
Outcome measures
| Measure |
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S1)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 60 mg solution under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S2)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 120 mg suspension under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S3-1)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 200 mg with fasted condition under period 1.
|
A Single Dose MT-1186 Under Fed Condition(Part 1, Cohort S3-2)
n=5 Participants
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.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S4)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension with xanthan under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S5)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S6)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 30 mg solution under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S7)
n=6 Participants
Healthy Caucasian male subjects receive a single dose of MT-1186 200 mg suspension under fasted condition.
|
Matching Placebo Under Fasted Condition (a Sngle Dose Cohorts)
n=6 Participants
Healthy Japanese/Caucasian male subjects receive a single dose of matching placebo.
|
Multiple Doses MT-1186 (Part 2, Cohort M1)
n=6 Participants
Healthy Japanese male subjects receive multiple doses of MT-1186 120 mg suspension under fasted condition.
|
Multiple Doses MT-1186 (Part 2, Cohort M2)
Healthy Japanese male subjects receive multiple doses of MT-1186 200 mg suspension under fasted condition.
|
Matching Placebo (Multiple Doses Cohorts)
Healthy Japanese male subjects receive multiple doses of matching placebo under fasted condition.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Reach Maximum Plasma Concentration (Tmax) of Sulfate Conjugate
Day 1
|
0.6 h
Standard Deviation 0.2
|
0.8 h
Standard Deviation 0.3
|
1.0 h
Standard Deviation 0.0
|
1.3 h
Standard Deviation 0.5
|
1.3 h
Standard Deviation 0.3
|
1.4 h
Standard Deviation 0.4
|
0.5 h
Standard Deviation 0.3
|
0.9 h
Standard Deviation 0.4
|
0.8 h
Standard Deviation 0.3
|
0.9 h
Standard Deviation 0.2
|
—
|
—
|
|
Time to Reach Maximum Plasma Concentration (Tmax) of Sulfate Conjugate
Day 5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.8 h
Standard Deviation 0.3
|
0.8 h
Standard Deviation 0.3
|
—
|
—
|
PRIMARY outcome
Timeframe: 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 5Population: 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).
Outcome measures
| Measure |
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S1)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 60 mg solution under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S2)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 120 mg suspension under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S3-1)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 200 mg with fasted condition under period 1.
|
A Single Dose MT-1186 Under Fed Condition(Part 1, Cohort S3-2)
n=5 Participants
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.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S4)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension with xanthan under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S5)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S6)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 30 mg solution under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S7)
n=6 Participants
Healthy Caucasian male subjects receive a single dose of MT-1186 200 mg suspension under fasted condition.
|
Matching Placebo Under Fasted Condition (a Sngle Dose Cohorts)
n=6 Participants
Healthy Japanese/Caucasian male subjects receive a single dose of matching placebo.
|
Multiple Doses MT-1186 (Part 2, Cohort M1)
n=6 Participants
Healthy Japanese male subjects receive multiple doses of MT-1186 120 mg suspension under fasted condition.
|
Multiple Doses MT-1186 (Part 2, Cohort M2)
Healthy Japanese male subjects receive multiple doses of MT-1186 200 mg suspension under fasted condition.
|
Matching Placebo (Multiple Doses Cohorts)
Healthy Japanese male subjects receive multiple doses of matching placebo under fasted condition.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Reach Maximum Plasma Concentration (Tmax) of Glucuronide Conjugate
Day 1
|
0.5 h
Standard Deviation 0.3
|
0.6 h
Standard Deviation 0.2
|
0.6 h
Standard Deviation 0.2
|
1.2 h
Standard Deviation 0.6
|
1.0 h
Standard Deviation 0.3
|
1.1 h
Standard Deviation 0.4
|
0.5 h
Standard Deviation 0.3
|
0.9 h
Standard Deviation 0.4
|
0.7 h
Standard Deviation 0.3
|
0.6 h
Standard Deviation 0.2
|
—
|
—
|
|
Time to Reach Maximum Plasma Concentration (Tmax) of Glucuronide Conjugate
Day 5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.6 h
Standard Deviation 0.2
|
0.7 h
Standard Deviation 0.3
|
—
|
—
|
PRIMARY outcome
Timeframe: 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 5Population: 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).
Outcome measures
| Measure |
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S1)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 60 mg solution under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S2)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 120 mg suspension under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S3-1)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 200 mg with fasted condition under period 1.
|
A Single Dose MT-1186 Under Fed Condition(Part 1, Cohort S3-2)
n=5 Participants
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.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S4)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension with xanthan under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S5)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S6)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 30 mg solution under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S7)
n=6 Participants
Healthy Caucasian male subjects receive a single dose of MT-1186 200 mg suspension under fasted condition.
|
Matching Placebo Under Fasted Condition (a Sngle Dose Cohorts)
n=6 Participants
Healthy Japanese/Caucasian male subjects receive a single dose of matching placebo.
|
Multiple Doses MT-1186 (Part 2, Cohort M1)
n=6 Participants
Healthy Japanese male subjects receive multiple doses of MT-1186 120 mg suspension under fasted condition.
|
Multiple Doses MT-1186 (Part 2, Cohort M2)
Healthy Japanese male subjects receive multiple doses of MT-1186 200 mg suspension under fasted condition.
|
Matching Placebo (Multiple Doses Cohorts)
Healthy Japanese male subjects receive multiple doses of matching placebo under fasted condition.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Terminal Elimination Half-life (t1/2) of Unchanged Edaravone
Day 1
|
3.2 h
Standard Deviation 0.9
|
5.1 h
Standard Deviation 1.5
|
9.1 h
Standard Deviation 2.4
|
5.2 h
Standard Deviation 1.7
|
11.8 h
Standard Deviation 4.
|
9.1 h
Standard Deviation 3.3
|
2.4 h
Standard Deviation 0.7
|
6.5 h
Standard Deviation 1.7
|
4.6 h
Standard Deviation 0.4
|
4.2 h
Standard Deviation 0.2
|
—
|
—
|
|
Terminal Elimination Half-life (t1/2) of Unchanged Edaravone
Day 5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
8.7 h
Standard Deviation 3.2
|
12.4 h
Standard Deviation 1.9
|
—
|
—
|
PRIMARY outcome
Timeframe: 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 5Population: 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).
Outcome measures
| Measure |
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S1)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 60 mg solution under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S2)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 120 mg suspension under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S3-1)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 200 mg with fasted condition under period 1.
|
A Single Dose MT-1186 Under Fed Condition(Part 1, Cohort S3-2)
n=5 Participants
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.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S4)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension with xanthan under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S5)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S6)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 30 mg solution under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S7)
n=6 Participants
Healthy Caucasian male subjects receive a single dose of MT-1186 200 mg suspension under fasted condition.
|
Matching Placebo Under Fasted Condition (a Sngle Dose Cohorts)
n=6 Participants
Healthy Japanese/Caucasian male subjects receive a single dose of matching placebo.
|
Multiple Doses MT-1186 (Part 2, Cohort M1)
n=6 Participants
Healthy Japanese male subjects receive multiple doses of MT-1186 120 mg suspension under fasted condition.
|
Multiple Doses MT-1186 (Part 2, Cohort M2)
Healthy Japanese male subjects receive multiple doses of MT-1186 200 mg suspension under fasted condition.
|
Matching Placebo (Multiple Doses Cohorts)
Healthy Japanese male subjects receive multiple doses of matching placebo under fasted condition.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Terminal Elimination Half-life (t1/2) of Sulfate Conjugate
Day 1
|
7.9 h
Standard Deviation 2.6
|
7.3 h
Standard Deviation 2.6
|
5.9 h
Standard Deviation 1.7
|
5.1 h
Standard Deviation 1.3
|
6.0 h
Standard Deviation 1.6
|
4.9 h
Standard Deviation 0.3
|
5.2 h
Standard Deviation 0.6
|
6.4 h
Standard Deviation 2.6
|
3.7 h
Standard Deviation 0.2
|
3.4 h
Standard Deviation 0.3
|
—
|
—
|
|
Terminal Elimination Half-life (t1/2) of Sulfate Conjugate
Day 5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
6.2 h
Standard Deviation 0.4
|
6.8 h
Standard Deviation 1.0
|
—
|
—
|
PRIMARY outcome
Timeframe: 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 5Population: 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).
Outcome measures
| Measure |
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S1)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 60 mg solution under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S2)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 120 mg suspension under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S3-1)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 200 mg with fasted condition under period 1.
|
A Single Dose MT-1186 Under Fed Condition(Part 1, Cohort S3-2)
n=5 Participants
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.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S4)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension with xanthan under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S5)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S6)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 30 mg solution under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S7)
n=6 Participants
Healthy Caucasian male subjects receive a single dose of MT-1186 200 mg suspension under fasted condition.
|
Matching Placebo Under Fasted Condition (a Sngle Dose Cohorts)
n=6 Participants
Healthy Japanese/Caucasian male subjects receive a single dose of matching placebo.
|
Multiple Doses MT-1186 (Part 2, Cohort M1)
n=6 Participants
Healthy Japanese male subjects receive multiple doses of MT-1186 120 mg suspension under fasted condition.
|
Multiple Doses MT-1186 (Part 2, Cohort M2)
Healthy Japanese male subjects receive multiple doses of MT-1186 200 mg suspension under fasted condition.
|
Matching Placebo (Multiple Doses Cohorts)
Healthy Japanese male subjects receive multiple doses of matching placebo under fasted condition.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Terminal Elimination Half-life (t1/2) of Glucuronide Conjugate
Day 1
|
3.4 h
Standard Deviation 1.1
|
3.2 h
Standard Deviation 0.9
|
4.3 h
Standard Deviation 0.7
|
3.8 h
Standard Deviation 0.9
|
5.9 h
Standard Deviation 1.4
|
4.8 h
Standard Deviation 0.5
|
2.8 h
Standard Deviation 0.9
|
4.7 h
Standard Deviation 1.2
|
3.5 h
Standard Deviation 0.2
|
3.2 h
Standard Deviation 0.4
|
—
|
—
|
|
Terminal Elimination Half-life (t1/2) of Glucuronide Conjugate
Day 5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
3.9 h
Standard Deviation 0.3
|
5.2 h
Standard Deviation 2.0
|
—
|
—
|
PRIMARY outcome
Timeframe: 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 5Population: 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).
Outcome measures
| Measure |
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S1)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 60 mg solution under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S2)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 120 mg suspension under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S3-1)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 200 mg with fasted condition under period 1.
|
A Single Dose MT-1186 Under Fed Condition(Part 1, Cohort S3-2)
n=5 Participants
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.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S4)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension with xanthan under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S5)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S6)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 30 mg solution under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S7)
n=6 Participants
Healthy Caucasian male subjects receive a single dose of MT-1186 200 mg suspension under fasted condition.
|
Matching Placebo Under Fasted Condition (a Sngle Dose Cohorts)
n=6 Participants
Healthy Japanese/Caucasian male subjects receive a single dose of matching placebo.
|
Multiple Doses MT-1186 (Part 2, Cohort M1)
n=6 Participants
Healthy Japanese male subjects receive multiple doses of MT-1186 120 mg suspension under fasted condition.
|
Multiple Doses MT-1186 (Part 2, Cohort M2)
Healthy Japanese male subjects receive multiple doses of MT-1186 200 mg suspension under fasted condition.
|
Matching Placebo (Multiple Doses Cohorts)
Healthy Japanese male subjects receive multiple doses of matching placebo under fasted condition.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Lambda-z of Unchanged Edaravone
Day 1
|
0.23 1/h
Standard Deviation 0.05
|
0.14 1/h
Standard Deviation 0.03
|
0.08 1/h
Standard Deviation 0.02
|
0.14 1/h
Standard Deviation 0.04
|
0.07 1/h
Standard Deviation 0.02
|
0.08 1/h
Standard Deviation 0.02
|
0.31 1/h
Standard Deviation 0.11
|
0.11 1/h
Standard Deviation 0.03
|
0.15 1/h
Standard Deviation 0.01
|
0.17 1/h
Standard Deviation 0.01
|
—
|
—
|
|
Lambda-z of Unchanged Edaravone
Day 5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.09 1/h
Standard Deviation 0.03
|
0.06 1/h
Standard Deviation 0.01
|
—
|
—
|
PRIMARY outcome
Timeframe: 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 5Population: 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).
Outcome measures
| Measure |
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S1)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 60 mg solution under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S2)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 120 mg suspension under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S3-1)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 200 mg with fasted condition under period 1.
|
A Single Dose MT-1186 Under Fed Condition(Part 1, Cohort S3-2)
n=5 Participants
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.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S4)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension with xanthan under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S5)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S6)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 30 mg solution under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S7)
n=6 Participants
Healthy Caucasian male subjects receive a single dose of MT-1186 200 mg suspension under fasted condition.
|
Matching Placebo Under Fasted Condition (a Sngle Dose Cohorts)
n=6 Participants
Healthy Japanese/Caucasian male subjects receive a single dose of matching placebo.
|
Multiple Doses MT-1186 (Part 2, Cohort M1)
n=6 Participants
Healthy Japanese male subjects receive multiple doses of MT-1186 120 mg suspension under fasted condition.
|
Multiple Doses MT-1186 (Part 2, Cohort M2)
Healthy Japanese male subjects receive multiple doses of MT-1186 200 mg suspension under fasted condition.
|
Matching Placebo (Multiple Doses Cohorts)
Healthy Japanese male subjects receive multiple doses of matching placebo under fasted condition.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Lambda-z of Sulfate Conjugate
Day 1
|
0.10 1/h
Standard Deviation 0.03
|
0.11 1/h
Standard Deviation 0.04
|
0.12 1/h
Standard Deviation 0.02
|
0.14 1/h
Standard Deviation 0.03
|
0.12 1/h
Standard Deviation 0.03
|
0.14 1/h
Standard Deviation 0.01
|
0.14 1/h
Standard Deviation 0.02
|
0.12 1/h
Standard Deviation 0.03
|
0.19 1/h
Standard Deviation 0.01
|
0.20 1/h
Standard Deviation 0.02
|
—
|
—
|
|
Lambda-z of Sulfate Conjugate
Day 5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.11 1/h
Standard Deviation 0.01
|
0.10 1/h
Standard Deviation 0.02
|
—
|
—
|
PRIMARY outcome
Timeframe: 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 5Population: 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).
Outcome measures
| Measure |
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S1)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 60 mg solution under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S2)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 120 mg suspension under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S3-1)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 200 mg with fasted condition under period 1.
|
A Single Dose MT-1186 Under Fed Condition(Part 1, Cohort S3-2)
n=5 Participants
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.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S4)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension with xanthan under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S5)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S6)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 30 mg solution under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S7)
n=6 Participants
Healthy Caucasian male subjects receive a single dose of MT-1186 200 mg suspension under fasted condition.
|
Matching Placebo Under Fasted Condition (a Sngle Dose Cohorts)
n=6 Participants
Healthy Japanese/Caucasian male subjects receive a single dose of matching placebo.
|
Multiple Doses MT-1186 (Part 2, Cohort M1)
n=6 Participants
Healthy Japanese male subjects receive multiple doses of MT-1186 120 mg suspension under fasted condition.
|
Multiple Doses MT-1186 (Part 2, Cohort M2)
Healthy Japanese male subjects receive multiple doses of MT-1186 200 mg suspension under fasted condition.
|
Matching Placebo (Multiple Doses Cohorts)
Healthy Japanese male subjects receive multiple doses of matching placebo under fasted condition.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Lambda-z of Glucuronide Conjugate
Day 1
|
0.23 1/h
Standard Deviation 0.09
|
0.23 1/h
Standard Deviation 0.07
|
0.17 1/h
Standard Deviation 0.03
|
0.19 1/h
Standard Deviation 0.05
|
0.12 1/h
Standard Deviation 0.02
|
0.15 1/h
Standard Deviation 0.01
|
0.27 1/h
Standard Deviation 0.07
|
0.16 1/h
Standard Deviation 0.04
|
0.20 1/h
Standard Deviation 0.01
|
0.22 1/h
Standard Deviation 0.03
|
—
|
—
|
|
Lambda-z of Glucuronide Conjugate
Day 5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.18 1/h
Standard Deviation 0.01
|
0.15 1/h
Standard Deviation 0.05
|
—
|
—
|
PRIMARY outcome
Timeframe: 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 5Population: 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).
Outcome measures
| Measure |
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S1)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 60 mg solution under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S2)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 120 mg suspension under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S3-1)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 200 mg with fasted condition under period 1.
|
A Single Dose MT-1186 Under Fed Condition(Part 1, Cohort S3-2)
n=5 Participants
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.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S4)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension with xanthan under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S5)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S6)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 30 mg solution under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S7)
n=6 Participants
Healthy Caucasian male subjects receive a single dose of MT-1186 200 mg suspension under fasted condition.
|
Matching Placebo Under Fasted Condition (a Sngle Dose Cohorts)
n=6 Participants
Healthy Japanese/Caucasian male subjects receive a single dose of matching placebo.
|
Multiple Doses MT-1186 (Part 2, Cohort M1)
n=6 Participants
Healthy Japanese male subjects receive multiple doses of MT-1186 120 mg suspension under fasted condition.
|
Multiple Doses MT-1186 (Part 2, Cohort M2)
Healthy Japanese male subjects receive multiple doses of MT-1186 200 mg suspension under fasted condition.
|
Matching Placebo (Multiple Doses Cohorts)
Healthy Japanese male subjects receive multiple doses of matching placebo under fasted condition.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Residence Time (MRT) of Unchanged Edaravone
Day 1
|
1.92 h
Standard Deviation 0.46
|
2.07 h
Standard Deviation 0.26
|
1.98 h
Standard Deviation 0.15
|
3.41 h
Standard Deviation 0.62
|
2.14 h
Standard Deviation 0.20
|
2.42 h
Standard Deviation 0.45
|
2.02 h
Standard Deviation 0.20
|
2.02 h
Standard Deviation 0.32
|
1.94 h
Standard Deviation 0.15
|
1.90 h
Standard Deviation 0.26
|
—
|
—
|
|
Mean Residence Time (MRT) of Unchanged Edaravone
Day 5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
2.17 h
Standard Deviation 0.24
|
2.28 h
Standard Deviation 0.37
|
—
|
—
|
PRIMARY outcome
Timeframe: 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 5Population: 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).
Outcome measures
| Measure |
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S1)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 60 mg solution under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S2)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 120 mg suspension under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S3-1)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 200 mg with fasted condition under period 1.
|
A Single Dose MT-1186 Under Fed Condition(Part 1, Cohort S3-2)
n=5 Participants
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.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S4)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension with xanthan under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S5)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S6)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 30 mg solution under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S7)
n=6 Participants
Healthy Caucasian male subjects receive a single dose of MT-1186 200 mg suspension under fasted condition.
|
Matching Placebo Under Fasted Condition (a Sngle Dose Cohorts)
n=6 Participants
Healthy Japanese/Caucasian male subjects receive a single dose of matching placebo.
|
Multiple Doses MT-1186 (Part 2, Cohort M1)
n=6 Participants
Healthy Japanese male subjects receive multiple doses of MT-1186 120 mg suspension under fasted condition.
|
Multiple Doses MT-1186 (Part 2, Cohort M2)
Healthy Japanese male subjects receive multiple doses of MT-1186 200 mg suspension under fasted condition.
|
Matching Placebo (Multiple Doses Cohorts)
Healthy Japanese male subjects receive multiple doses of matching placebo under fasted condition.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Total Clearance (CL/F) of Unchanged Edaravone
Day 1
|
79.77 L/h
Standard Deviation 26.21
|
60.29 L/h
Standard Deviation 22.90
|
32.73 L/h
Standard Deviation 6.42
|
87.07 L/h
Standard Deviation 22.96
|
26.42 L/h
Standard Deviation 2.30
|
36.11 L/h
Standard Deviation 13.62
|
119.41 L/h
Standard Deviation 43.64
|
46.72 L/h
Standard Deviation 20.27
|
64.51 L/h
Standard Deviation 11.64
|
53.40 L/h
Standard Deviation 20.46
|
—
|
—
|
|
Apparent Total Clearance (CL/F) of Unchanged Edaravone
Day 5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
57.64 L/h
Standard Deviation 14.54
|
50.74 L/h
Standard Deviation 18.08
|
—
|
—
|
PRIMARY outcome
Timeframe: 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 5Population: 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).
Outcome measures
| Measure |
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S1)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 60 mg solution under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S2)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 120 mg suspension under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S3-1)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 200 mg with fasted condition under period 1.
|
A Single Dose MT-1186 Under Fed Condition(Part 1, Cohort S3-2)
n=5 Participants
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.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S4)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension with xanthan under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S5)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S6)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 30 mg solution under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S7)
n=6 Participants
Healthy Caucasian male subjects receive a single dose of MT-1186 200 mg suspension under fasted condition.
|
Matching Placebo Under Fasted Condition (a Sngle Dose Cohorts)
n=6 Participants
Healthy Japanese/Caucasian male subjects receive a single dose of matching placebo.
|
Multiple Doses MT-1186 (Part 2, Cohort M1)
n=6 Participants
Healthy Japanese male subjects receive multiple doses of MT-1186 120 mg suspension under fasted condition.
|
Multiple Doses MT-1186 (Part 2, Cohort M2)
Healthy Japanese male subjects receive multiple doses of MT-1186 200 mg suspension under fasted condition.
|
Matching Placebo (Multiple Doses Cohorts)
Healthy Japanese male subjects receive multiple doses of matching placebo under fasted condition.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Distribution Volume at Elimination Phase (Vz/F) and Apparent Distribution Volume at Steady State (Vss/F) of Unchanged Edaravone
Vz/F (Part 1), Vss/F (Part 2): Day1
|
348.98 L
Standard Deviation 87.82
|
422.67 L
Standard Deviation 126.97
|
426.49 L
Standard Deviation 130.84
|
620.73 L
Standard Deviation 139.24
|
457.99 L
Standard Deviation 188.01
|
457.37 L
Standard Deviation 175.69
|
384.51 L
Standard Deviation 96.92
|
408.95 L
Standard Deviation 121.29
|
126.41 L
Standard Deviation 29.65
|
105.90 L
Standard Deviation 57.04
|
—
|
—
|
|
Apparent Distribution Volume at Elimination Phase (Vz/F) and Apparent Distribution Volume at Steady State (Vss/F) of Unchanged Edaravone
Vss/F (only Part 2): Day 5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
125.94 L
Standard Deviation 40.36
|
121.32 L
Standard Deviation 66.83
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.Population: 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.
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.
Outcome measures
| Measure |
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S1)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 60 mg solution under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S2)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 120 mg suspension under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S3-1)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 200 mg with fasted condition under period 1.
|
A Single Dose MT-1186 Under Fed Condition(Part 1, Cohort S3-2)
n=6 Participants
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.
|
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.
|
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.
|
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.
|
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.
|
Matching Placebo Under Fasted Condition (a Sngle Dose Cohorts)
Healthy Japanese/Caucasian male subjects receive a single dose of matching placebo.
|
Multiple Doses MT-1186 (Part 2, Cohort M1)
Healthy Japanese male subjects receive multiple doses of MT-1186 120 mg suspension under fasted condition.
|
Multiple Doses MT-1186 (Part 2, Cohort M2)
Healthy Japanese male subjects receive multiple doses of MT-1186 200 mg suspension under fasted condition.
|
Matching Placebo (Multiple Doses Cohorts)
Healthy Japanese male subjects receive multiple doses of matching placebo under fasted condition.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change of Heart Rate (HR) From Baseline
0.25h
|
1.8 bpm
Standard Error 0.91
|
-1.2 bpm
Standard Error 0.91
|
1.8 bpm
Standard Error 0.96
|
-0.2 bpm
Standard Error 0.92
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change of Heart Rate (HR) From Baseline
0.5h
|
-0.2 bpm
Standard Error 1.01
|
0.2 bpm
Standard Error 1.01
|
1.3 bpm
Standard Error 1.06
|
1.2 bpm
Standard Error 1.02
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change of Heart Rate (HR) From Baseline
1h
|
-0.1 bpm
Standard Error 1.28
|
-1.7 bpm
Standard Error 1.28
|
0.2 bpm
Standard Error 1.34
|
-0.2 bpm
Standard Error 1.29
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change of Heart Rate (HR) From Baseline
1.5h
|
-1.2 bpm
Standard Error 1.00
|
-0.3 bpm
Standard Error 1.00
|
0.2 bpm
Standard Error 1.04
|
-0.1 bpm
Standard Error 1.01
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change of Heart Rate (HR) From Baseline
2h
|
-0.1 bpm
Standard Error 0.95
|
0.4 bpm
Standard Error 0.95
|
0.9 bpm
Standard Error 0.99
|
-0.1 bpm
Standard Error 0.96
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change of Heart Rate (HR) From Baseline
4h
|
-0.7 bpm
Standard Error 1.36
|
-1.6 bpm
Standard Error 1.36
|
-0.1 bpm
Standard Error 1.42
|
-1.5 bpm
Standard Error 1.37
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change of Heart Rate (HR) From Baseline
6h
|
3.2 bpm
Standard Error 1.88
|
6.4 bpm
Standard Error 1.87
|
3.8 bpm
Standard Error 1.96
|
3.8 bpm
Standard Error 1.89
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change of Heart Rate (HR) From Baseline
8h
|
4.4 bpm
Standard Error 1.72
|
4.1 bpm
Standard Error 1.72
|
6.2 bpm
Standard Error 1.80
|
3.4 bpm
Standard Error 1.74
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change of Heart Rate (HR) From Baseline
12h
|
1.9 bpm
Standard Error 2.07
|
10.1 bpm
Standard Error 2.07
|
7.6 bpm
Standard Error 2.16
|
4.6 bpm
Standard Error 2.09
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change of Heart Rate (HR) From Baseline
24h
|
1.3 bpm
Standard Error 1.54
|
1.7 bpm
Standard Error 1.54
|
2.2 bpm
Standard Error 1.61
|
-1 bpm
Standard Error 1.55
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change of Heart Rate (HR) From Baseline
36h
|
8.1 bpm
Standard Error 3.07
|
9.9 bpm
Standard Error 3.06
|
13.2 bpm
Standard Error 3.21
|
5.7 bpm
Standard Error 3.10
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change of Heart Rate (HR) From Baseline
48h
|
4.3 bpm
Standard Error 2.51
|
8.2 bpm
Standard Error 2.51
|
8.4 bpm
Standard Error 2.62
|
2.4 bpm
Standard Error 2.53
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.Population: 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.
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.
Outcome measures
| Measure |
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S1)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 60 mg solution under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S2)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 120 mg suspension under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S3-1)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 200 mg with fasted condition under period 1.
|
A Single Dose MT-1186 Under Fed Condition(Part 1, Cohort S3-2)
n=6 Participants
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.
|
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.
|
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.
|
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.
|
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.
|
Matching Placebo Under Fasted Condition (a Sngle Dose Cohorts)
Healthy Japanese/Caucasian male subjects receive a single dose of matching placebo.
|
Multiple Doses MT-1186 (Part 2, Cohort M1)
Healthy Japanese male subjects receive multiple doses of MT-1186 120 mg suspension under fasted condition.
|
Multiple Doses MT-1186 (Part 2, Cohort M2)
Healthy Japanese male subjects receive multiple doses of MT-1186 200 mg suspension under fasted condition.
|
Matching Placebo (Multiple Doses Cohorts)
Healthy Japanese male subjects receive multiple doses of matching placebo under fasted condition.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change of PR Interval (PR) From Baseline
0.25h
|
-6.8 msec
Standard Error 1.91
|
-3.3 msec
Standard Error 1.99
|
-5.7 msec
Standard Error 1.92
|
-4.5 msec
Standard Error 2.06
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change of PR Interval (PR) From Baseline
0.5h
|
-4.2 msec
Standard Error 1.35
|
0.1 msec
Standard Error 1.40
|
-2.4 msec
Standard Error 1.36
|
-3.4 msec
Standard Error 1.45
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change of PR Interval (PR) From Baseline
1h
|
-4.2 msec
Standard Error 1.68
|
2.1 msec
Standard Error 1.74
|
-4.0 msec
Standard Error 1.68
|
-4.7 msec
Standard Error 1.80
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change of PR Interval (PR) From Baseline
1.5h
|
-5.2 msec
Standard Error 2.23
|
0.0 msec
Standard Error 2.31
|
-4.8 msec
Standard Error 2.24
|
-5.3 msec
Standard Error 2.40
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change of PR Interval (PR) From Baseline
2h
|
-5.9 msec
Standard Error 1.90
|
-0.8 msec
Standard Error 1.97
|
-4.5 msec
Standard Error 1.91
|
-5.9 msec
Standard Error 2.05
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change of PR Interval (PR) From Baseline
4h
|
-3.0 msec
Standard Error 2.64
|
-3.0 msec
Standard Error 2.74
|
-5.3 msec
Standard Error 2.66
|
-5.4 msec
Standard Error 2.85
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change of PR Interval (PR) From Baseline
6h
|
-5.5 msec
Standard Error 1.91
|
-9.6 msec
Standard Error 1.98
|
-6.3 msec
Standard Error 1.92
|
-6.6 msec
Standard Error 2.06
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change of PR Interval (PR) From Baseline
8h
|
-11.6 msec
Standard Error 2.60
|
-9.0 msec
Standard Error 2.70
|
-9.9 msec
Standard Error 2.62
|
-11.9 msec
Standard Error 2.80
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change of PR Interval (PR) From Baseline
12h
|
-6.6 msec
Standard Error 3.91
|
-12.0 msec
Standard Error 4.06
|
-9.0 msec
Standard Error 3.93
|
-11.8 msec
Standard Error 4.21
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change of PR Interval (PR) From Baseline
24h
|
-2.1 msec
Standard Error 2.62
|
-1.6 msec
Standard Error 2.72
|
-8.9 msec
Standard Error 2.63
|
-1.1 msec
Standard Error 2.82
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change of PR Interval (PR) From Baseline
36h
|
-5.7 msec
Standard Error 3.77
|
-6.8 msec
Standard Error 3.91
|
-6.2 msec
Standard Error 3.78
|
-9.5 msec
Standard Error 4.06
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change of PR Interval (PR) From Baseline
48h
|
-3.3 msec
Standard Error 2.63
|
0.6 msec
Standard Error 2.73
|
-3.2 msec
Standard Error 2.64
|
-5.4 msec
Standard Error 2.83
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.Population: 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.
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.
Outcome measures
| Measure |
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S1)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 60 mg solution under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S2)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 120 mg suspension under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S3-1)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 200 mg with fasted condition under period 1.
|
A Single Dose MT-1186 Under Fed Condition(Part 1, Cohort S3-2)
n=6 Participants
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.
|
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.
|
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.
|
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.
|
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.
|
Matching Placebo Under Fasted Condition (a Sngle Dose Cohorts)
Healthy Japanese/Caucasian male subjects receive a single dose of matching placebo.
|
Multiple Doses MT-1186 (Part 2, Cohort M1)
Healthy Japanese male subjects receive multiple doses of MT-1186 120 mg suspension under fasted condition.
|
Multiple Doses MT-1186 (Part 2, Cohort M2)
Healthy Japanese male subjects receive multiple doses of MT-1186 200 mg suspension under fasted condition.
|
Matching Placebo (Multiple Doses Cohorts)
Healthy Japanese male subjects receive multiple doses of matching placebo under fasted condition.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change of QTcF Interval (QTcF) From Baseline
0.25h
|
2.0 msec
Standard Error 1.60
|
0.7 msec
Standard Error 1.60
|
1.6 msec
Standard Error 1.63
|
0.8 msec
Standard Error 1.71
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change of QTcF Interval (QTcF) From Baseline
0.5h
|
-2.2 msec
Standard Error 1.32
|
1.1 msec
Standard Error 1.31
|
-3.8 msec
Standard Error 1.34
|
-4.9 msec
Standard Error 1.41
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change of QTcF Interval (QTcF) From Baseline
1h
|
0.3 msec
Standard Error 2.02
|
-0.1 msec
Standard Error 2.02
|
-4.7 msec
Standard Error 2.06
|
0.5 msec
Standard Error 2.17
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change of QTcF Interval (QTcF) From Baseline
1.5h
|
-5.2 msec
Standard Error 2.23
|
2.7 msec
Standard Error 1.68
|
-1.9 msec
Standard Error 1.71
|
-5.3 msec
Standard Error 2.40
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change of QTcF Interval (QTcF) From Baseline
2h
|
1.2 msec
Standard Error 1.68
|
1.5 msec
Standard Error 2.34
|
-5.1 msec
Standard Error 2.39
|
0.8 msec
Standard Error 1.80
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change of QTcF Interval (QTcF) From Baseline
4h
|
2.3 msec
Standard Error 2.85
|
-0.9 msec
Standard Error 2.85
|
1.4 msec
Standard Error 2.90
|
0.7 msec
Standard Error 3.06
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change of QTcF Interval (QTcF) From Baseline
6h
|
-5.7 msec
Standard Error 2.96
|
-2.9 msec
Standard Error 2.96
|
-7.6 msec
Standard Error 3.01
|
-2.4 msec
Standard Error 3.18
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change of QTcF Interval (QTcF) From Baseline
8h
|
-5.3 msec
Standard Error 2.62
|
-2.9 msec
Standard Error 2.62
|
-7.0 msec
Standard Error 2.66
|
-6.9 msec
Standard Error 2.81
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change of QTcF Interval (QTcF) From Baseline
12h
|
-2.3 msec
Standard Error 2.42
|
-4.0 msec
Standard Error 2.42
|
-3.1 msec
Standard Error 2.47
|
-3.3 msec
Standard Error 2.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change of QTcF Interval (QTcF) From Baseline
24h
|
2.0 msec
Standard Error 2.42
|
-1.2 msec
Standard Error 2.42
|
-5.7 msec
Standard Error 2.46
|
-3.1 msec
Standard Error 2.60
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change of QTcF Interval (QTcF) From Baseline
36h
|
-3.0 msec
Standard Error 2.96
|
-5.0 msec
Standard Error 2.96
|
-5.1 msec
Standard Error 3.01
|
-1.4 msec
Standard Error 3.18
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change of QTcF Interval (QTcF) From Baseline
48h
|
-1.0 msec
Standard Error 3.22
|
-1.5 msec
Standard Error 3.22
|
-4.4 msec
Standard Error 3.28
|
-0.1 msec
Standard Error 3.46
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.Population: 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.
Holter ECG data were recorded in part 1, Cohorts S4, S5, and S6.
Outcome measures
| Measure |
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S1)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 60 mg solution under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S2)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 120 mg suspension under fasted condition.
|
A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S3-1)
n=6 Participants
Healthy Japanese male subjects receive a single dose of MT-1186 200 mg with fasted condition under period 1.
|
A Single Dose MT-1186 Under Fed Condition(Part 1, Cohort S3-2)
n=6 Participants
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.
|
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.
|
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.
|
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.
|
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.
|
Matching Placebo Under Fasted Condition (a Sngle Dose Cohorts)
Healthy Japanese/Caucasian male subjects receive a single dose of matching placebo.
|
Multiple Doses MT-1186 (Part 2, Cohort M1)
Healthy Japanese male subjects receive multiple doses of MT-1186 120 mg suspension under fasted condition.
|
Multiple Doses MT-1186 (Part 2, Cohort M2)
Healthy Japanese male subjects receive multiple doses of MT-1186 200 mg suspension under fasted condition.
|
Matching Placebo (Multiple Doses Cohorts)
Healthy Japanese male subjects receive multiple doses of matching placebo under fasted condition.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change of QRS Duration (QRS) From Baseline
0.25h
|
-0.7 msec
Standard Error 0.85
|
-0.4 msec
Standard Error 0.84
|
0.4 msec
Standard Error 0.87
|
-2.0 msec
Standard Error 0.88
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change of QRS Duration (QRS) From Baseline
0.5h
|
-0.3 msec
Standard Error 0.77
|
-0.8 msec
Standard Error 0.77
|
-0.5 msec
Standard Error 0.80
|
-1.6 msec
Standard Error 0.80
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change of QRS Duration (QRS) From Baseline
1h
|
-0.3 msec
Standard Error 0.70
|
-1.5 msec
Standard Error 0.69
|
0.5 msec
Standard Error 0.72
|
-1.4 msec
Standard Error 0.72
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change of QRS Duration (QRS) From Baseline
1.5h
|
-0.4 msec
Standard Error 0.70
|
-0.7 msec
Standard Error 0.80
|
0.4 msec
Standard Error 0.83
|
-1.4 msec
Standard Error 0.72
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change of QRS Duration (QRS) From Baseline
2h
|
-1.5 msec
Standard Error 0.98
|
-0.5 msec
Standard Error 0.98
|
0.2 msec
Standard Error 1.01
|
-2.7 msec
Standard Error 1.02
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change of QRS Duration (QRS) From Baseline
4h
|
-0.5 msec
Standard Error 1.36
|
-2.1 msec
Standard Error 1.36
|
-0.4 msec
Standard Error 1.41
|
-0.5 msec
Standard Error 1.42
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change of QRS Duration (QRS) From Baseline
6h
|
-0.3 msec
Standard Error 1.31
|
1.1 msec
Standard Error 1.31
|
-0.8 msec
Standard Error 1.36
|
0.7 msec
Standard Error 1.37
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change of QRS Duration (QRS) From Baseline
8h
|
-1.2 msec
Standard Error 1.50
|
0.0 msec
Standard Error 1.50
|
-2.4 msec
Standard Error 1.55
|
-1.3 msec
Standard Error 1.57
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change of QRS Duration (QRS) From Baseline
12h
|
0.4 msec
Standard Error 1.71
|
-2.1 msec
Standard Error 1.71
|
-2.0 msec
Standard Error 1.77
|
0.0 msec
Standard Error 1.78
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change of QRS Duration (QRS) From Baseline
24h
|
-0.9 msec
Standard Error 1.26
|
-2.2 msec
Standard Error 1.25
|
-1.4 msec
Standard Error 1.30
|
-1.2 msec
Standard Error 1.31
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change of QRS Duration (QRS) From Baseline
36h
|
-0.2 msec
Standard Error 1.76
|
-1.5 msec
Standard Error 1.75
|
-2.4 msec
Standard Error 1.81
|
0.4 msec
Standard Error 1.83
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change of QRS Duration (QRS) From Baseline
48h
|
-1.7 msec
Standard Error 1.18
|
-1.5 msec
Standard Error 1.17
|
-1.4 msec
Standard Error 1.22
|
-0.1 msec
Standard Error 1.23
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
A Single Dose MT-1186 (Part 1, Cohort S1)
A Single Dose MT-1186 (Part 1, Cohort S2)
A Single Dose MT-1186 (Part 1, Cohort S3)
A Single Dose MT-1186 (Part 1, Cohort S4)
A Single Dose MT-1186 (Part 1, Cohort S5)
A Single Dose MT-1186 (Part 1, Cohort S6)
A Single Dose MT-1186 (Part 1, Cohort S7)
Matching Placebo (a Single Dose Cohorts)
Multiple Doses MT-1186 (Part 2, Cohort M1)
Multiple Doses MT-1186 (Part 2, Cohort M2)
Matching Placebo (Multiple Doses Cohorts)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
A Single Dose MT-1186 (Part 1, Cohort S1)
n=6 participants at risk
Healthy Japanese male subjects receive a single dose of MT-1186 60 mg solution.
|
A Single Dose MT-1186 (Part 1, Cohort S2)
n=6 participants at risk
Healthy Japanese male subjects receive a single dose of MT-1186 120 mg suspension.
|
A Single Dose MT-1186 (Part 1, Cohort S3)
n=6 participants at risk
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.
|
A Single Dose MT-1186 (Part 1, Cohort S4)
n=6 participants at risk
Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension with xanthan.
|
A Single Dose MT-1186 (Part 1, Cohort S5)
n=6 participants at risk
Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension.
|
A Single Dose MT-1186 (Part 1, Cohort S6)
n=6 participants at risk
Healthy Japanese male subjects receive a single dose of MT-1186 30 mg suspension.
|
A Single Dose MT-1186 (Part 1, Cohort S7)
n=6 participants at risk
Healthy Caucasian male subjects receive a single dose of MT-1186 200 mg suspension.
|
Matching Placebo (a Single Dose Cohorts)
n=14 participants at risk
Healthy Japanese/Caucasian male subjects receive a single dose of matching placebo.
|
Multiple Doses MT-1186 (Part 2, Cohort M1)
n=6 participants at risk
Healthy Japanese male subjects receive multiple doses of MT-1186 120 mg suspension.
|
Multiple Doses MT-1186 (Part 2, Cohort M2)
n=6 participants at risk
Healthy Japanese male subjects receive multiple doses of MT-1186 200 mg suspension.
|
Matching Placebo (Multiple Doses Cohorts)
n=6 participants at risk
Healthy Japanese male subjects receive multiple doses of matching placebo.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
16.7%
1/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/14 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
16.7%
1/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/14 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
7.1%
1/14 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/14 • 8 days in part 1, 12 days in part 2
|
16.7%
1/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
33.3%
2/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/14 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
16.7%
1/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
|
Nervous system disorders
Presyncope
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
16.7%
1/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/14 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
|
General disorders
Pyrexia
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
16.7%
1/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/14 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/14 • 8 days in part 1, 12 days in part 2
|
16.7%
1/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/14 • 8 days in part 1, 12 days in part 2
|
16.7%
1/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/14 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
16.7%
1/6 • 8 days in part 1, 12 days in part 2
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
16.7%
1/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/14 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
16.7%
1/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
|
Investigations
Blood glucose increased
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
16.7%
1/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/14 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
|
Investigations
Blood uric acid increased
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
7.1%
1/14 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
|
Investigations
Blood urine present
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
16.7%
1/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/14 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
|
Investigations
White blood cell count increased
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
16.7%
1/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
16.7%
1/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/14 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
|
Investigations
Protein urine present
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/14 • 8 days in part 1, 12 days in part 2
|
16.7%
1/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
0.00%
0/6 • 8 days in part 1, 12 days in part 2
|
Additional Information
Clinical Trials, Information Desk
Tanabe Pharma Corporation
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER