Trial Outcomes & Findings for Study of Oral Edaravone in Healthy Adult Males (NCT NCT04481750)

NCT ID: NCT04481750

Last Updated: 2026-01-07

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

74 participants

Primary outcome timeframe

Day 1 to 8 in Part 1, up to 12 days in Part 2

Results posted on

2026-01-07

Participant Flow

Participant milestones

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

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

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 2

Population: 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

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 5

Population: 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

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 5

Population: 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

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 5

Population: 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

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 5

Population: 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

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 5

Population: 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

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 5

Population: 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

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 5

Population: 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

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 5

Population: 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

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 5

Population: 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

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 5

Population: 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

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 5

Population: 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

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 5

Population: 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

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 5

Population: 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

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 5

Population: 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

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 5

Population: 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

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 5

Population: 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

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 5

Population: 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

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 5

Population: 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

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 5

Population: 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

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

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

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

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

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)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

A Single Dose MT-1186 (Part 1, Cohort S2)

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

A Single Dose MT-1186 (Part 1, Cohort S3)

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

A Single Dose MT-1186 (Part 1, Cohort S4)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

A Single Dose MT-1186 (Part 1, Cohort S5)

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

A Single Dose MT-1186 (Part 1, Cohort S6)

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

A Single Dose MT-1186 (Part 1, Cohort S7)

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Matching Placebo (a Single Dose Cohorts)

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

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

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

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

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Matching Placebo (Multiple Doses Cohorts)

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

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

Phone: Please e-mail

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: OTHER