Trial Outcomes & Findings for Clinical Pharmacology Study of Oral Edaravone in Healthy Adult Males (Drug Interaction Study and Preliminary Regimen-Finding Study) (NCT NCT04481789)
NCT ID: NCT04481789
Last Updated: 2026-05-22
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
84 participants
Primary outcome timeframe
Group 1 (Day 6, 9 and 12) and Group 2 (Day 3 and 6): Pre-dose, 0.083, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours post-dose.
Results posted on
2026-05-22
Participant Flow
Participant milestones
| Measure |
Rosuvastatin, Sildenafil, and Edaravone Group 1 of Cohort 1
A single-sequence study in which healthy male subjects receive a single dose of rosuvastatin on Day 1 followed by a single dose of sildenafil on Day 4. Oral edaravone will be administered from Day 6 to 13 with co-administration of rosuvastatin and sildenafil on Day 9 and 12, respectively.
|
Furosemide and Edaravone Group 2 of Cohort 1
A single-sequence study in which healthy male subjects receive a single dose of furosemide on Day 1. Oral edaravone will be administered from Day 3 to 7 with co-administration of furosemide on Day 6.
|
Edaravone Group 3 of Cohort 2
A three-way crossover study in which Japanese healthy male subjects receive a single dose of Oral edaravone under several dosing condition on Day 1, 4, and 7 according to their treatment sequence with 3-day wash out between doses.
Period 1:Japanese subjects receive a single dose of Edaravone under fasted condition on Day 1.
Period 2: Japanese subjects receive a single dose of Edaravone1 hour before a high-fat meal on Day 4.
Period 3: Japanese subjects receive a single dose of Edaravone 4 hours after a high-fat meal on Day 7.
|
Edaravone Group 4 of Cohort 2
A three-way crossover study in which Japanese healthy male subjects receive a single dose of Oral edaravone under several dosing condition on Day 1, 4, and 7 according to their treatment sequence with 3-day wash out between doses.
Period 1: Japanese subjects receive a single dose of Edaravone 4 hours after a high-fat meal.
Period 2: Japanese subjects receive a single dose of Edaravone under fasted condition.
Period 3: Japanese subjects receive a single dose of Edaravone1 hour before a high-fat meal.
|
Edaravone Group 5 of Cohort 2
A three-way crossover study in which Japanese healthy male subjects receive a single dose o Oral edaravone under several dosing condition on Day 1, 4, and 7 according to their treatment sequence with 3-day wash out between doses.
Period 1: Japanese subjects receive a single dose of Edaravone1 hour before a high-fat meal.
Period 2: Japanese subjects receive a single dose of Edaravone 4 hours after a high-fat meal.
Period 3: Japanese subjects receive a single dose of Edaravone under fasted condition.
|
Caucasian Group of Cohort 2
Caucasian healthy male subjects receive a single dose of MT-1186 under fasted condition at the same period with Japanese subjects on Day 1, 4, or 7 according to their treatment schedule.
|
|---|---|---|---|---|---|---|
|
Period 1
STARTED
|
32
|
34
|
3
|
3
|
3
|
3
|
|
Period 1
COMPLETED
|
31
|
34
|
3
|
3
|
3
|
3
|
|
Period 1
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Period 2
STARTED
|
31
|
34
|
3
|
3
|
3
|
3
|
|
Period 2
COMPLETED
|
31
|
34
|
3
|
3
|
3
|
3
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 3
STARTED
|
31
|
0
|
3
|
3
|
3
|
3
|
|
Period 3
COMPLETED
|
31
|
0
|
3
|
3
|
3
|
3
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Rosuvastatin, Sildenafil, and Edaravone Group 1 of Cohort 1
A single-sequence study in which healthy male subjects receive a single dose of rosuvastatin on Day 1 followed by a single dose of sildenafil on Day 4. Oral edaravone will be administered from Day 6 to 13 with co-administration of rosuvastatin and sildenafil on Day 9 and 12, respectively.
|
Furosemide and Edaravone Group 2 of Cohort 1
A single-sequence study in which healthy male subjects receive a single dose of furosemide on Day 1. Oral edaravone will be administered from Day 3 to 7 with co-administration of furosemide on Day 6.
|
Edaravone Group 3 of Cohort 2
A three-way crossover study in which Japanese healthy male subjects receive a single dose of Oral edaravone under several dosing condition on Day 1, 4, and 7 according to their treatment sequence with 3-day wash out between doses.
Period 1:Japanese subjects receive a single dose of Edaravone under fasted condition on Day 1.
Period 2: Japanese subjects receive a single dose of Edaravone1 hour before a high-fat meal on Day 4.
Period 3: Japanese subjects receive a single dose of Edaravone 4 hours after a high-fat meal on Day 7.
|
Edaravone Group 4 of Cohort 2
A three-way crossover study in which Japanese healthy male subjects receive a single dose of Oral edaravone under several dosing condition on Day 1, 4, and 7 according to their treatment sequence with 3-day wash out between doses.
Period 1: Japanese subjects receive a single dose of Edaravone 4 hours after a high-fat meal.
Period 2: Japanese subjects receive a single dose of Edaravone under fasted condition.
Period 3: Japanese subjects receive a single dose of Edaravone1 hour before a high-fat meal.
|
Edaravone Group 5 of Cohort 2
A three-way crossover study in which Japanese healthy male subjects receive a single dose o Oral edaravone under several dosing condition on Day 1, 4, and 7 according to their treatment sequence with 3-day wash out between doses.
Period 1: Japanese subjects receive a single dose of Edaravone1 hour before a high-fat meal.
Period 2: Japanese subjects receive a single dose of Edaravone 4 hours after a high-fat meal.
Period 3: Japanese subjects receive a single dose of Edaravone under fasted condition.
|
Caucasian Group of Cohort 2
Caucasian healthy male subjects receive a single dose of MT-1186 under fasted condition at the same period with Japanese subjects on Day 1, 4, or 7 according to their treatment schedule.
|
|---|---|---|---|---|---|---|
|
Period 1
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Clinical Pharmacology Study of Oral Edaravone in Healthy Adult Males (Drug Interaction Study and Preliminary Regimen-Finding Study)
Baseline characteristics by cohort
| Measure |
Furosemide and Edaravone Group 2 of Cohort 1
n=34 Participants
A single-sequence study in which healthy male subjects receive a single dose of furosemide on Day 1. MT-1186 will be administered from Day 3 to 7 with co-administration of furosemide on Day 6.
|
Japanese Combined of Cohort 2
n=9 Participants
A three-way crossover study in which Japanese healthy male subjects receive a single dose of MT-1186 under several dosing condition on Day 1, 4, and 7 according to their treatment sequence with 3-day wash out between doses.
|
Caucasian Group of Cohort 2
n=9 Participants
Caucasian healthy male subjects receive a single dose of MT-1186 under fasted condition at the same period with Japanese subjects on Day 1, 4, or 7 according to their treatment schedule.
|
Total
n=84 Participants
Total of all reporting groups
|
Rosuvastatin, Sildenafil, and Edaravone Group 1 of Cohort 1
n=32 Participants
A single-sequence study in which healthy male subjects receive a single dose of rosuvastatin on Day 1 followed by a single dose of sildenafil on Day 4. MT-1186 will be administered from Day 6 to 13 with co-administration of rosuvastatin and sildenafil on Day 9 and 12, respectively.
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=2 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
34 Participants
n=4 Participants
|
9 Participants
n=6 Participants
|
9 Participants
n=8 Participants
|
84 Participants
n=8 Participants
|
32 Participants
n=2 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=2 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=2 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=4 Participants
|
9 Participants
n=6 Participants
|
9 Participants
n=8 Participants
|
84 Participants
n=8 Participants
|
32 Participants
n=2 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Asian
|
34 Participants
n=4 Participants
|
9 Participants
n=6 Participants
|
0 Participants
n=8 Participants
|
75 Participants
n=8 Participants
|
32 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
9 Participants
n=8 Participants
|
9 Participants
n=8 Participants
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=2 Participants
|
PRIMARY outcome
Timeframe: Before rosuvastatin dosing and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 hrs post-dose, Before sildenafil dosing and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hrs post-dose, Before furosemide dosing and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hrs post-dosePopulation: This study was conducted in 2 cohorts; the first cohort assessed DDIs with multiple doses of oral edaravone, and the second cohort evaluated PK and racial differences in PK parameters with oral administration of edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2).
Outcome measures
| Measure |
Edaravone + Sildenafil: Group 1 of Cohort 1
n=34 Participants
Day 12 to Day 20 including end of study assessment. The subjects receive edaravone from Day 12 and 13 with co-administration of sildenafil on Day 12.
|
Combined: After Day 6: Group 1 of Cohort 1
n=34 Participants
Day 6 to Day 20 including end of study assessment.
|
Furosemide Alone: Group 2 of Cohort 1
Day 1 to Day 2. The subjects receive a single dose of furosemide on Day 1.
|
Edaravone Alone: Group 2 of Cohort 1
Day 3 to Day 5. The subjects receive a single dose of edaravone from Day 3 to Day 5.
|
Edaravone + Furosemide: Group 2 of Cohort 1
Day 6 to Day 14 including end of study assessment. The subjects receive edaravone on Day 6 to Day 7 with co-administration of furosemide on Day 6.
|
Combined : After Day 3: Group 2 of Cohort 1
Day 3 to Day 14 including end of study assessment.
|
Edaravone Single Dose Under Fasting Condition: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose 1 Hour After a High-fat Meal: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose 4 Hours After a High-fat Meal: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose Under Fasting Condition: White Conbined
White combined
|
Japanese
n=32 Participants
Japanese: Edaravone single dose under fasting condition
|
White
n=31 Participants
White: Edaravone single dose under fasting condition
|
Edaravone Single Dose 4 Hours After a High-fat Meal
n=31 Participants
Japanese combined
|
Edaravone + Rosuvastatin: Group 1 of Cohort 1
n=31 Participants
Day 9 to Day 11. The subjects receive edaravone from Day 6 to 11 with co-administration of rosuvastatin on Day 9.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) of Rosuvastatin, Sildenafil and Furosemide.
|
3861 ng*h/mL
Standard Deviation 1031
|
3906 ng*h/mL
Standard Deviation 736.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
161 ng*h/mL
Standard Deviation 66.8
|
165 ng*h/mL
Standard Deviation 60.2
|
532 ng*h/mL
Standard Deviation 236
|
482 ng*h/mL
Standard Deviation 195
|
PRIMARY outcome
Timeframe: Before rosuvastatin dosing and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 hrs post-dose, Before sildenafil dosing and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hrs post-dose, Before furosemide dosing and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hrs post-dosePopulation: This study was conducted in 2 cohorts; the first cohort assessed DDIs with multiple doses of oral edaravone, and the second cohort evaluated PK and racial differences in PK parameters with oral administration of edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2).
Outcome measures
| Measure |
Edaravone + Sildenafil: Group 1 of Cohort 1
n=34 Participants
Day 12 to Day 20 including end of study assessment. The subjects receive edaravone from Day 12 and 13 with co-administration of sildenafil on Day 12.
|
Combined: After Day 6: Group 1 of Cohort 1
n=34 Participants
Day 6 to Day 20 including end of study assessment.
|
Furosemide Alone: Group 2 of Cohort 1
Day 1 to Day 2. The subjects receive a single dose of furosemide on Day 1.
|
Edaravone Alone: Group 2 of Cohort 1
Day 3 to Day 5. The subjects receive a single dose of edaravone from Day 3 to Day 5.
|
Edaravone + Furosemide: Group 2 of Cohort 1
Day 6 to Day 14 including end of study assessment. The subjects receive edaravone on Day 6 to Day 7 with co-administration of furosemide on Day 6.
|
Combined : After Day 3: Group 2 of Cohort 1
Day 3 to Day 14 including end of study assessment.
|
Edaravone Single Dose Under Fasting Condition: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose 1 Hour After a High-fat Meal: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose 4 Hours After a High-fat Meal: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose Under Fasting Condition: White Conbined
White combined
|
Japanese
n=32 Participants
Japanese: Edaravone single dose under fasting condition
|
White
n=31 Participants
White: Edaravone single dose under fasting condition
|
Edaravone Single Dose 4 Hours After a High-fat Meal
n=31 Participants
Japanese combined
|
Edaravone + Rosuvastatin: Group 1 of Cohort 1
n=31 Participants
Day 9 to Day 11. The subjects receive edaravone from Day 6 to 11 with co-administration of rosuvastatin on Day 9.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of Rosuvastatin, Sildenafil and Furosemide.
|
1676 ng/mL
Standard Deviation 777.7
|
1701 ng/mL
Standard Deviation 506.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
11.3 ng/mL
Standard Deviation 5.0
|
11.3 ng/mL
Standard Deviation 5.0
|
232 ng/mL
Standard Deviation 135
|
201 ng/mL
Standard Deviation 97.9
|
PRIMARY outcome
Timeframe: Before rosuvastatin dosing and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 hrs post-dose, Before sildenafil dosing and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hrs post-dose, Before furosemide dosing and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hrs post-dosePopulation: This study was conducted in 2 cohorts; the first cohort assessed DDIs with multiple doses of oral edaravone, and the second cohort evaluated PK and racial differences in PK parameters with oral administration of edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2).
Outcome measures
| Measure |
Edaravone + Sildenafil: Group 1 of Cohort 1
n=34 Participants
Day 12 to Day 20 including end of study assessment. The subjects receive edaravone from Day 12 and 13 with co-administration of sildenafil on Day 12.
|
Combined: After Day 6: Group 1 of Cohort 1
n=34 Participants
Day 6 to Day 20 including end of study assessment.
|
Furosemide Alone: Group 2 of Cohort 1
Day 1 to Day 2. The subjects receive a single dose of furosemide on Day 1.
|
Edaravone Alone: Group 2 of Cohort 1
Day 3 to Day 5. The subjects receive a single dose of edaravone from Day 3 to Day 5.
|
Edaravone + Furosemide: Group 2 of Cohort 1
Day 6 to Day 14 including end of study assessment. The subjects receive edaravone on Day 6 to Day 7 with co-administration of furosemide on Day 6.
|
Combined : After Day 3: Group 2 of Cohort 1
Day 3 to Day 14 including end of study assessment.
|
Edaravone Single Dose Under Fasting Condition: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose 1 Hour After a High-fat Meal: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose 4 Hours After a High-fat Meal: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose Under Fasting Condition: White Conbined
White combined
|
Japanese
n=32 Participants
Japanese: Edaravone single dose under fasting condition
|
White
n=31 Participants
White: Edaravone single dose under fasting condition
|
Edaravone Single Dose 4 Hours After a High-fat Meal
n=31 Participants
Japanese combined
|
Edaravone + Rosuvastatin: Group 1 of Cohort 1
n=31 Participants
Day 9 to Day 11. The subjects receive edaravone from Day 6 to 11 with co-administration of rosuvastatin on Day 9.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Tmax of Rosuvastatin, Sildenafil and Furosemide.
|
1.7 h
Standard Deviation 1.1
|
1.8 h
Standard Deviation 1.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
4.6 h
Standard Deviation 1.5
|
5.1 h
Standard Deviation 1.4
|
0.8 h
Standard Deviation 0.4
|
0.9 h
Standard Deviation 0.5
|
PRIMARY outcome
Timeframe: Before rosuvastatin dosing and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 hrs post-dose, Before sildenafil dosing and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hrs post-dose, Before furosemide dosing and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hrs post-dosePopulation: This study was conducted in 2 cohorts; the first cohort assessed DDIs with multiple doses of oral edaravone, and the second cohort evaluated PK and racial differences in PK parameters with oral administration of edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2).
Outcome measures
| Measure |
Edaravone + Sildenafil: Group 1 of Cohort 1
n=34 Participants
Day 12 to Day 20 including end of study assessment. The subjects receive edaravone from Day 12 and 13 with co-administration of sildenafil on Day 12.
|
Combined: After Day 6: Group 1 of Cohort 1
n=34 Participants
Day 6 to Day 20 including end of study assessment.
|
Furosemide Alone: Group 2 of Cohort 1
Day 1 to Day 2. The subjects receive a single dose of furosemide on Day 1.
|
Edaravone Alone: Group 2 of Cohort 1
Day 3 to Day 5. The subjects receive a single dose of edaravone from Day 3 to Day 5.
|
Edaravone + Furosemide: Group 2 of Cohort 1
Day 6 to Day 14 including end of study assessment. The subjects receive edaravone on Day 6 to Day 7 with co-administration of furosemide on Day 6.
|
Combined : After Day 3: Group 2 of Cohort 1
Day 3 to Day 14 including end of study assessment.
|
Edaravone Single Dose Under Fasting Condition: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose 1 Hour After a High-fat Meal: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose 4 Hours After a High-fat Meal: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose Under Fasting Condition: White Conbined
White combined
|
Japanese
n=32 Participants
Japanese: Edaravone single dose under fasting condition
|
White
n=31 Participants
White: Edaravone single dose under fasting condition
|
Edaravone Single Dose 4 Hours After a High-fat Meal
n=31 Participants
Japanese combined
|
Edaravone + Rosuvastatin: Group 1 of Cohort 1
n=31 Participants
Day 9 to Day 11. The subjects receive edaravone from Day 6 to 11 with co-administration of rosuvastatin on Day 9.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
T1/2 of Rosuvastatin, Sildenafil and Furosemide.
|
6.9 h
Standard Deviation 3.5
|
5.8 h
Standard Deviation 3.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
14.4 h
Standard Deviation 4.0
|
12.1 h
Standard Deviation 2.2
|
2.8 h
Standard Deviation 1.1
|
3.5 h
Standard Deviation 1.4
|
PRIMARY outcome
Timeframe: Group 1 (Day 6, 9 and 12) and Group 2 (Day 3 and 6): Pre-dose, 0.083, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours post-dose.Population: This study was conducted in 2 cohorts; the first cohort assessed DDIs with multiple doses of oral edaravone, and the second cohort evaluated PK and racial differences in PK parameters with oral administration of edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Day 3 of Group 1 and Day 9 and 12 of Group 2 were zero participant because no data was collected.
Outcome measures
| Measure |
Edaravone + Sildenafil: Group 1 of Cohort 1
Day 12 to Day 20 including end of study assessment. The subjects receive edaravone from Day 12 and 13 with co-administration of sildenafil on Day 12.
|
Combined: After Day 6: Group 1 of Cohort 1
Day 6 to Day 20 including end of study assessment.
|
Furosemide Alone: Group 2 of Cohort 1
Day 1 to Day 2. The subjects receive a single dose of furosemide on Day 1.
|
Edaravone Alone: Group 2 of Cohort 1
Day 3 to Day 5. The subjects receive a single dose of edaravone from Day 3 to Day 5.
|
Edaravone + Furosemide: Group 2 of Cohort 1
Day 6 to Day 14 including end of study assessment. The subjects receive edaravone on Day 6 to Day 7 with co-administration of furosemide on Day 6.
|
Combined : After Day 3: Group 2 of Cohort 1
Day 3 to Day 14 including end of study assessment.
|
Edaravone Single Dose Under Fasting Condition: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose 1 Hour After a High-fat Meal: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose 4 Hours After a High-fat Meal: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose Under Fasting Condition: White Conbined
White combined
|
Japanese
n=31 Participants
Japanese: Edaravone single dose under fasting condition
|
White
n=34 Participants
White: Edaravone single dose under fasting condition
|
Edaravone Single Dose 4 Hours After a High-fat Meal
Japanese combined
|
Edaravone + Rosuvastatin: Group 1 of Cohort 1
Day 9 to Day 11. The subjects receive edaravone from Day 6 to 11 with co-administration of rosuvastatin on Day 9.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUC0-inf of Unchanged Edaravone.
Day 3: Group 2 (Edaravone alone)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
2535 ng*h/mL
Standard Deviation 919
|
—
|
—
|
|
AUC0-inf of Unchanged Edaravone.
Day 6: Group 1 (Edaravpne alone), Group 2 (Edaravone + Furosemide)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
2616 ng*h/mL
Standard Deviation 730
|
2746 ng*h/mL
Standard Deviation 1015
|
—
|
—
|
|
AUC0-inf of Unchanged Edaravone.
Day 9: Group 1 (Edaravone + Rosuvastatin), Group 2 Not Applicable
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
2591 ng*h/mL
Standard Deviation 671
|
—
|
—
|
—
|
|
AUC0-inf of Unchanged Edaravone.
Day 12: Group 1 (Edaravone + Sildenafil), Group 2 Not Applicable
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
2656 ng*h/mL
Standard Deviation 712
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Group 1 (Day 6, 9 and 12) and Group 2 (Day 3 and 6): Pre-dose, 0.083, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours post-dose.Population: This study was conducted in 2 cohorts; the first cohort assessed DDIs with multiple doses of oral edaravone, and the second cohort evaluated PK and racial differences in PK parameters with oral administration of edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Day 3 of Group 1 and Day 9 and 12 of Group 2 were zero participant because no data was collected.
Outcome measures
| Measure |
Edaravone + Sildenafil: Group 1 of Cohort 1
Day 12 to Day 20 including end of study assessment. The subjects receive edaravone from Day 12 and 13 with co-administration of sildenafil on Day 12.
|
Combined: After Day 6: Group 1 of Cohort 1
Day 6 to Day 20 including end of study assessment.
|
Furosemide Alone: Group 2 of Cohort 1
Day 1 to Day 2. The subjects receive a single dose of furosemide on Day 1.
|
Edaravone Alone: Group 2 of Cohort 1
Day 3 to Day 5. The subjects receive a single dose of edaravone from Day 3 to Day 5.
|
Edaravone + Furosemide: Group 2 of Cohort 1
Day 6 to Day 14 including end of study assessment. The subjects receive edaravone on Day 6 to Day 7 with co-administration of furosemide on Day 6.
|
Combined : After Day 3: Group 2 of Cohort 1
Day 3 to Day 14 including end of study assessment.
|
Edaravone Single Dose Under Fasting Condition: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose 1 Hour After a High-fat Meal: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose 4 Hours After a High-fat Meal: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose Under Fasting Condition: White Conbined
White combined
|
Japanese
n=31 Participants
Japanese: Edaravone single dose under fasting condition
|
White
n=34 Participants
White: Edaravone single dose under fasting condition
|
Edaravone Single Dose 4 Hours After a High-fat Meal
Japanese combined
|
Edaravone + Rosuvastatin: Group 1 of Cohort 1
Day 9 to Day 11. The subjects receive edaravone from Day 6 to 11 with co-administration of rosuvastatin on Day 9.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax of Unchanged Edaravone.
Day 3: Group 2 (Edaravone alone)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
2180 ng/mL
Standard Deviation 1035
|
—
|
—
|
|
Cmax of Unchanged Edaravone.
Day 6: Group 1 (Edaravpne alone), Group 2 (Edaravone + Furosemide)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
2724 ng/mL
Standard Deviation 1533
|
2074 ng/mL
Standard Deviation 1051
|
—
|
—
|
|
Cmax of Unchanged Edaravone.
Day 9: Group 1 (Edaravone + Rosuvastatin)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
2302 ng/mL
Standard Deviation 943
|
—
|
—
|
—
|
|
Cmax of Unchanged Edaravone.
Day 12: Group 1 (Edaravone + Sildenafil)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
2455 ng/mL
Standard Deviation 1111
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Group 1 (Day 6, 9 and 12) and Group 2 (Day 3 and 6): Pre-dose, 0.083, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours post-dose.Population: This study was conducted in 2 cohorts; the first cohort assessed DDIs with multiple doses of oral edaravone, and the second cohort evaluated PK and racial differences in PK parameters with oral administration of edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Day 3 of Group 1 and Day 9 and 12 of Group 2 were zero participants because no data was collected.
Outcome measures
| Measure |
Edaravone + Sildenafil: Group 1 of Cohort 1
Day 12 to Day 20 including end of study assessment. The subjects receive edaravone from Day 12 and 13 with co-administration of sildenafil on Day 12.
|
Combined: After Day 6: Group 1 of Cohort 1
Day 6 to Day 20 including end of study assessment.
|
Furosemide Alone: Group 2 of Cohort 1
Day 1 to Day 2. The subjects receive a single dose of furosemide on Day 1.
|
Edaravone Alone: Group 2 of Cohort 1
Day 3 to Day 5. The subjects receive a single dose of edaravone from Day 3 to Day 5.
|
Edaravone + Furosemide: Group 2 of Cohort 1
Day 6 to Day 14 including end of study assessment. The subjects receive edaravone on Day 6 to Day 7 with co-administration of furosemide on Day 6.
|
Combined : After Day 3: Group 2 of Cohort 1
Day 3 to Day 14 including end of study assessment.
|
Edaravone Single Dose Under Fasting Condition: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose 1 Hour After a High-fat Meal: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose 4 Hours After a High-fat Meal: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose Under Fasting Condition: White Conbined
White combined
|
Japanese
n=31 Participants
Japanese: Edaravone single dose under fasting condition
|
White
n=34 Participants
White: Edaravone single dose under fasting condition
|
Edaravone Single Dose 4 Hours After a High-fat Meal
Japanese combined
|
Edaravone + Rosuvastatin: Group 1 of Cohort 1
Day 9 to Day 11. The subjects receive edaravone from Day 6 to 11 with co-administration of rosuvastatin on Day 9.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Tmax of Unchanged Edaravone.
Day 3: Group 2 (Edaravone alone)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.34 h
Standard Deviation 0.19
|
—
|
—
|
|
Tmax of Unchanged Edaravone.
Day 6: Group 1 (Edaravpne alone), Group 2 (Edaravone + Furosemide)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.30 h
Standard Deviation 0.10
|
0.34 h
Standard Deviation 0.17
|
—
|
—
|
|
Tmax of Unchanged Edaravone.
Day 9: Group 1 (Edaravone + Rosuvastatin)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.34 h
Standard Deviation 0.13
|
—
|
—
|
—
|
|
Tmax of Unchanged Edaravone.
Day 12: Group 1 (Edaravone + Sildenafil)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.32 h
Standard Deviation 0.17
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Group 1 (Day 6, 9 and 12) and Group 2 (Day 3 and 6): Pre-dose, 0.083, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours post-dose.Population: This study was conducted in 2 cohorts; the first cohort assessed DDIs with multiple doses of oral edaravone, and the second cohort evaluated PK and racial differences in PK parameters with oral administration of edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Day 3 of Group 1 and Day 9 and 12 of Group 2 were zero participants because no data was collected.
Outcome measures
| Measure |
Edaravone + Sildenafil: Group 1 of Cohort 1
Day 12 to Day 20 including end of study assessment. The subjects receive edaravone from Day 12 and 13 with co-administration of sildenafil on Day 12.
|
Combined: After Day 6: Group 1 of Cohort 1
Day 6 to Day 20 including end of study assessment.
|
Furosemide Alone: Group 2 of Cohort 1
Day 1 to Day 2. The subjects receive a single dose of furosemide on Day 1.
|
Edaravone Alone: Group 2 of Cohort 1
Day 3 to Day 5. The subjects receive a single dose of edaravone from Day 3 to Day 5.
|
Edaravone + Furosemide: Group 2 of Cohort 1
Day 6 to Day 14 including end of study assessment. The subjects receive edaravone on Day 6 to Day 7 with co-administration of furosemide on Day 6.
|
Combined : After Day 3: Group 2 of Cohort 1
Day 3 to Day 14 including end of study assessment.
|
Edaravone Single Dose Under Fasting Condition: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose 1 Hour After a High-fat Meal: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose 4 Hours After a High-fat Meal: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose Under Fasting Condition: White Conbined
White combined
|
Japanese
n=31 Participants
Japanese: Edaravone single dose under fasting condition
|
White
n=34 Participants
White: Edaravone single dose under fasting condition
|
Edaravone Single Dose 4 Hours After a High-fat Meal
Japanese combined
|
Edaravone + Rosuvastatin: Group 1 of Cohort 1
Day 9 to Day 11. The subjects receive edaravone from Day 6 to 11 with co-administration of rosuvastatin on Day 9.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
T1/2 of Unchanged Edaravone.
Day 3: Group 2 (Edaravone alone)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
4.67 h
Standard Deviation 0.92
|
—
|
—
|
|
T1/2 of Unchanged Edaravone.
Day 6: Group 1 (Edaravpne alone), Group 2 (Edaravone + Furosemide)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
5.23 h
Standard Deviation 1.11
|
5.52 h
Standard Deviation 0.60
|
—
|
—
|
|
T1/2 of Unchanged Edaravone.
Day 9: Group 1 (Edaravone + Rosuvastatin)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
6.60 h
Standard Deviation 1.18
|
—
|
—
|
—
|
|
T1/2 of Unchanged Edaravone.
Day 12: Group 1 (Edaravone + Sildenafil)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
6.69 h
Standard Deviation 1.31
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Group 2 (Day 3 and 6): Pre-dose, 0.083, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours post-dose.Population: This study was conducted in 2 cohorts; the first cohort assessed DDIs with multiple doses of oral edaravone, and the second cohort evaluated PK and racial differences in PK parameters with oral administration of edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Sulfate and glucuronide conjugates were not measured in Cohort 1 Group 1.
Outcome measures
| Measure |
Edaravone + Sildenafil: Group 1 of Cohort 1
Day 12 to Day 20 including end of study assessment. The subjects receive edaravone from Day 12 and 13 with co-administration of sildenafil on Day 12.
|
Combined: After Day 6: Group 1 of Cohort 1
Day 6 to Day 20 including end of study assessment.
|
Furosemide Alone: Group 2 of Cohort 1
Day 1 to Day 2. The subjects receive a single dose of furosemide on Day 1.
|
Edaravone Alone: Group 2 of Cohort 1
Day 3 to Day 5. The subjects receive a single dose of edaravone from Day 3 to Day 5.
|
Edaravone + Furosemide: Group 2 of Cohort 1
Day 6 to Day 14 including end of study assessment. The subjects receive edaravone on Day 6 to Day 7 with co-administration of furosemide on Day 6.
|
Combined : After Day 3: Group 2 of Cohort 1
Day 3 to Day 14 including end of study assessment.
|
Edaravone Single Dose Under Fasting Condition: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose 1 Hour After a High-fat Meal: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose 4 Hours After a High-fat Meal: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose Under Fasting Condition: White Conbined
White combined
|
Japanese
n=34 Participants
Japanese: Edaravone single dose under fasting condition
|
White
White: Edaravone single dose under fasting condition
|
Edaravone Single Dose 4 Hours After a High-fat Meal
Japanese combined
|
Edaravone + Rosuvastatin: Group 1 of Cohort 1
Day 9 to Day 11. The subjects receive edaravone from Day 6 to 11 with co-administration of rosuvastatin on Day 9.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUC0-inf of Sulfate Conjugate.
Day 3: Group 2 (Edaravone alone)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
26576 ng*h/mL
Standard Deviation 6820
|
—
|
—
|
—
|
|
AUC0-inf of Sulfate Conjugate.
Day 6: Group 2 (Edaravone + Furosemide)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
30588 ng*h/mL
Standard Deviation 7064
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Group 2 (Day 3 and 6): Pre-dose, 0.083, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours post-dose.Population: This study was conducted in 2 cohorts; the first cohort assessed DDIs with multiple doses of oral edaravone, and the second cohort evaluated PK and racial differences in PK parameters with oral administration of edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Sulfate and glucuronide conjugates were not measured in Cohort 1 Group 1.
Outcome measures
| Measure |
Edaravone + Sildenafil: Group 1 of Cohort 1
Day 12 to Day 20 including end of study assessment. The subjects receive edaravone from Day 12 and 13 with co-administration of sildenafil on Day 12.
|
Combined: After Day 6: Group 1 of Cohort 1
Day 6 to Day 20 including end of study assessment.
|
Furosemide Alone: Group 2 of Cohort 1
Day 1 to Day 2. The subjects receive a single dose of furosemide on Day 1.
|
Edaravone Alone: Group 2 of Cohort 1
Day 3 to Day 5. The subjects receive a single dose of edaravone from Day 3 to Day 5.
|
Edaravone + Furosemide: Group 2 of Cohort 1
Day 6 to Day 14 including end of study assessment. The subjects receive edaravone on Day 6 to Day 7 with co-administration of furosemide on Day 6.
|
Combined : After Day 3: Group 2 of Cohort 1
Day 3 to Day 14 including end of study assessment.
|
Edaravone Single Dose Under Fasting Condition: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose 1 Hour After a High-fat Meal: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose 4 Hours After a High-fat Meal: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose Under Fasting Condition: White Conbined
White combined
|
Japanese
n=34 Participants
Japanese: Edaravone single dose under fasting condition
|
White
White: Edaravone single dose under fasting condition
|
Edaravone Single Dose 4 Hours After a High-fat Meal
Japanese combined
|
Edaravone + Rosuvastatin: Group 1 of Cohort 1
Day 9 to Day 11. The subjects receive edaravone from Day 6 to 11 with co-administration of rosuvastatin on Day 9.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax of Sulfate Conjugate.
Day 3: Group 2 (Edaravone alone)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
8115 ng/mL
Standard Deviation 1775
|
—
|
—
|
—
|
|
Cmax of Sulfate Conjugate.
Day 6: Group 2 (Edaravone + Furosemide)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
8702 ng/mL
Standard Deviation 2147
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Group 2 (Day 3 and 6): Pre-dose, 0.083, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours post-dose.Population: This study was conducted in 2 cohorts; the first cohort assessed DDIs with multiple doses of oral edaravone, and the second cohort evaluated PK and racial differences in PK parameters with oral administration of edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Sulfate and glucuronide conjugates were not measured in Cohort 1 Group 1.
Outcome measures
| Measure |
Edaravone + Sildenafil: Group 1 of Cohort 1
Day 12 to Day 20 including end of study assessment. The subjects receive edaravone from Day 12 and 13 with co-administration of sildenafil on Day 12.
|
Combined: After Day 6: Group 1 of Cohort 1
Day 6 to Day 20 including end of study assessment.
|
Furosemide Alone: Group 2 of Cohort 1
Day 1 to Day 2. The subjects receive a single dose of furosemide on Day 1.
|
Edaravone Alone: Group 2 of Cohort 1
Day 3 to Day 5. The subjects receive a single dose of edaravone from Day 3 to Day 5.
|
Edaravone + Furosemide: Group 2 of Cohort 1
Day 6 to Day 14 including end of study assessment. The subjects receive edaravone on Day 6 to Day 7 with co-administration of furosemide on Day 6.
|
Combined : After Day 3: Group 2 of Cohort 1
Day 3 to Day 14 including end of study assessment.
|
Edaravone Single Dose Under Fasting Condition: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose 1 Hour After a High-fat Meal: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose 4 Hours After a High-fat Meal: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose Under Fasting Condition: White Conbined
White combined
|
Japanese
n=34 Participants
Japanese: Edaravone single dose under fasting condition
|
White
White: Edaravone single dose under fasting condition
|
Edaravone Single Dose 4 Hours After a High-fat Meal
Japanese combined
|
Edaravone + Rosuvastatin: Group 1 of Cohort 1
Day 9 to Day 11. The subjects receive edaravone from Day 6 to 11 with co-administration of rosuvastatin on Day 9.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Tmax of Sulfate Conjugate.
Day 3: Group 2 (Edaravone alone)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.76 h
Standard Deviation 0.28
|
—
|
—
|
—
|
|
Tmax of Sulfate Conjugate.
Day 6: Group 2 (Edaravone + Furosemide)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.81 h
Standard Deviation 0.30
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Group 2 (Day 3 and 6): Pre-dose, 0.083, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours post-dose.Population: This study was conducted in 2 cohorts; the first cohort assessed DDIs with multiple doses of oral edaravone, and the second cohort evaluated PK and racial differences in PK parameters with oral administration of edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Sulfate and glucuronide conjugates were not measured in Cohort 1 Group 1.
Outcome measures
| Measure |
Edaravone + Sildenafil: Group 1 of Cohort 1
Day 12 to Day 20 including end of study assessment. The subjects receive edaravone from Day 12 and 13 with co-administration of sildenafil on Day 12.
|
Combined: After Day 6: Group 1 of Cohort 1
Day 6 to Day 20 including end of study assessment.
|
Furosemide Alone: Group 2 of Cohort 1
Day 1 to Day 2. The subjects receive a single dose of furosemide on Day 1.
|
Edaravone Alone: Group 2 of Cohort 1
Day 3 to Day 5. The subjects receive a single dose of edaravone from Day 3 to Day 5.
|
Edaravone + Furosemide: Group 2 of Cohort 1
Day 6 to Day 14 including end of study assessment. The subjects receive edaravone on Day 6 to Day 7 with co-administration of furosemide on Day 6.
|
Combined : After Day 3: Group 2 of Cohort 1
Day 3 to Day 14 including end of study assessment.
|
Edaravone Single Dose Under Fasting Condition: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose 1 Hour After a High-fat Meal: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose 4 Hours After a High-fat Meal: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose Under Fasting Condition: White Conbined
White combined
|
Japanese
n=34 Participants
Japanese: Edaravone single dose under fasting condition
|
White
White: Edaravone single dose under fasting condition
|
Edaravone Single Dose 4 Hours After a High-fat Meal
Japanese combined
|
Edaravone + Rosuvastatin: Group 1 of Cohort 1
Day 9 to Day 11. The subjects receive edaravone from Day 6 to 11 with co-administration of rosuvastatin on Day 9.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
T1/2 of Sulfate Conjugate.
Day 3: Group 2 (Edaravone alone)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
3.89 h
Standard Deviation 0.25
|
—
|
—
|
—
|
|
T1/2 of Sulfate Conjugate.
Day 6: Group 2 (Edaravone + Furosemide)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
4.20 h
Standard Deviation 0.33
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Group 2 (Day 3 and 6): Pre-dose, 0.083, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours post-dose.Population: This study was conducted in 2 cohorts; the first cohort assessed DDIs with multiple doses of oral edaravone, and the second cohort evaluated PK and racial differences in PK parameters with oral administration of edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Sulfate and glucuronide conjugates were not measured in Cohort 1 Group 1.
Outcome measures
| Measure |
Edaravone + Sildenafil: Group 1 of Cohort 1
Day 12 to Day 20 including end of study assessment. The subjects receive edaravone from Day 12 and 13 with co-administration of sildenafil on Day 12.
|
Combined: After Day 6: Group 1 of Cohort 1
Day 6 to Day 20 including end of study assessment.
|
Furosemide Alone: Group 2 of Cohort 1
Day 1 to Day 2. The subjects receive a single dose of furosemide on Day 1.
|
Edaravone Alone: Group 2 of Cohort 1
Day 3 to Day 5. The subjects receive a single dose of edaravone from Day 3 to Day 5.
|
Edaravone + Furosemide: Group 2 of Cohort 1
Day 6 to Day 14 including end of study assessment. The subjects receive edaravone on Day 6 to Day 7 with co-administration of furosemide on Day 6.
|
Combined : After Day 3: Group 2 of Cohort 1
Day 3 to Day 14 including end of study assessment.
|
Edaravone Single Dose Under Fasting Condition: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose 1 Hour After a High-fat Meal: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose 4 Hours After a High-fat Meal: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose Under Fasting Condition: White Conbined
White combined
|
Japanese
n=34 Participants
Japanese: Edaravone single dose under fasting condition
|
White
White: Edaravone single dose under fasting condition
|
Edaravone Single Dose 4 Hours After a High-fat Meal
Japanese combined
|
Edaravone + Rosuvastatin: Group 1 of Cohort 1
Day 9 to Day 11. The subjects receive edaravone from Day 6 to 11 with co-administration of rosuvastatin on Day 9.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUC0-inf of Glucuronide Conjugate.
Day 3: Group 2 (Edaravone alone)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
4817 ng*h/mL
Standard Deviation 1282
|
—
|
—
|
—
|
|
AUC0-inf of Glucuronide Conjugate.
Day 6: Group 2 (Edaravone + Furosemide)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
4953 ng*h/mL
Standard Deviation 1285
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Group 2 (Day 3 and 6): Pre-dose, 0.083, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours post-dose.Population: This study was conducted in 2 cohorts; the first cohort assessed DDIs with multiple doses of oral edaravone, and the second cohort evaluated PK and racial differences in PK parameters with oral administration of edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Sulfate and glucuronide conjugates were not measured in Cohort 1 Group 1.
Outcome measures
| Measure |
Edaravone + Sildenafil: Group 1 of Cohort 1
Day 12 to Day 20 including end of study assessment. The subjects receive edaravone from Day 12 and 13 with co-administration of sildenafil on Day 12.
|
Combined: After Day 6: Group 1 of Cohort 1
Day 6 to Day 20 including end of study assessment.
|
Furosemide Alone: Group 2 of Cohort 1
Day 1 to Day 2. The subjects receive a single dose of furosemide on Day 1.
|
Edaravone Alone: Group 2 of Cohort 1
Day 3 to Day 5. The subjects receive a single dose of edaravone from Day 3 to Day 5.
|
Edaravone + Furosemide: Group 2 of Cohort 1
Day 6 to Day 14 including end of study assessment. The subjects receive edaravone on Day 6 to Day 7 with co-administration of furosemide on Day 6.
|
Combined : After Day 3: Group 2 of Cohort 1
Day 3 to Day 14 including end of study assessment.
|
Edaravone Single Dose Under Fasting Condition: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose 1 Hour After a High-fat Meal: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose 4 Hours After a High-fat Meal: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose Under Fasting Condition: White Conbined
White combined
|
Japanese
n=34 Participants
Japanese: Edaravone single dose under fasting condition
|
White
White: Edaravone single dose under fasting condition
|
Edaravone Single Dose 4 Hours After a High-fat Meal
Japanese combined
|
Edaravone + Rosuvastatin: Group 1 of Cohort 1
Day 9 to Day 11. The subjects receive edaravone from Day 6 to 11 with co-administration of rosuvastatin on Day 9.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax of Glucuronide Conjugate.
Day 3: Group 2 (Edaravone alone)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
2318 ng/mL
Standard Deviation 649
|
—
|
—
|
—
|
|
Cmax of Glucuronide Conjugate.
Day 6: Group 2 (Edaravone + Furosemide)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
2304 ng/mL
Standard Deviation 694
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Group 2 (Day 3 and 6): Pre-dose, 0.083, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours post-dose.Population: This study was conducted in 2 cohorts; the first cohort assessed DDIs with multiple doses of oral edaravone, and the second cohort evaluated PK and racial differences in PK parameters with oral administration of edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Sulfate and glucuronide conjugates were not measured in Cohort 1 Group 1.
Outcome measures
| Measure |
Edaravone + Sildenafil: Group 1 of Cohort 1
Day 12 to Day 20 including end of study assessment. The subjects receive edaravone from Day 12 and 13 with co-administration of sildenafil on Day 12.
|
Combined: After Day 6: Group 1 of Cohort 1
Day 6 to Day 20 including end of study assessment.
|
Furosemide Alone: Group 2 of Cohort 1
Day 1 to Day 2. The subjects receive a single dose of furosemide on Day 1.
|
Edaravone Alone: Group 2 of Cohort 1
Day 3 to Day 5. The subjects receive a single dose of edaravone from Day 3 to Day 5.
|
Edaravone + Furosemide: Group 2 of Cohort 1
Day 6 to Day 14 including end of study assessment. The subjects receive edaravone on Day 6 to Day 7 with co-administration of furosemide on Day 6.
|
Combined : After Day 3: Group 2 of Cohort 1
Day 3 to Day 14 including end of study assessment.
|
Edaravone Single Dose Under Fasting Condition: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose 1 Hour After a High-fat Meal: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose 4 Hours After a High-fat Meal: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose Under Fasting Condition: White Conbined
White combined
|
Japanese
n=34 Participants
Japanese: Edaravone single dose under fasting condition
|
White
White: Edaravone single dose under fasting condition
|
Edaravone Single Dose 4 Hours After a High-fat Meal
Japanese combined
|
Edaravone + Rosuvastatin: Group 1 of Cohort 1
Day 9 to Day 11. The subjects receive edaravone from Day 6 to 11 with co-administration of rosuvastatin on Day 9.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Tmax of Glucuronide Conjugate.
Day 3: Group 2 (Edaravone alone)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.61 h
Standard Deviation 0.26
|
—
|
—
|
—
|
|
Tmax of Glucuronide Conjugate.
Day 6: Group 2 (Edaravone + Furosemide)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.57 h
Standard Deviation 0.18
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Group 2 (Day 3 and 6): Pre-dose, 0.083, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours post-dose.Population: This study was conducted in 2 cohorts; the first cohort assessed DDIs with multiple doses of oral edaravone, and the second cohort evaluated PK and racial differences in PK parameters with oral administration of edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Sulfate and glucuronide conjugates were not measured in Cohort 1 Group 1.
Outcome measures
| Measure |
Edaravone + Sildenafil: Group 1 of Cohort 1
Day 12 to Day 20 including end of study assessment. The subjects receive edaravone from Day 12 and 13 with co-administration of sildenafil on Day 12.
|
Combined: After Day 6: Group 1 of Cohort 1
Day 6 to Day 20 including end of study assessment.
|
Furosemide Alone: Group 2 of Cohort 1
Day 1 to Day 2. The subjects receive a single dose of furosemide on Day 1.
|
Edaravone Alone: Group 2 of Cohort 1
Day 3 to Day 5. The subjects receive a single dose of edaravone from Day 3 to Day 5.
|
Edaravone + Furosemide: Group 2 of Cohort 1
Day 6 to Day 14 including end of study assessment. The subjects receive edaravone on Day 6 to Day 7 with co-administration of furosemide on Day 6.
|
Combined : After Day 3: Group 2 of Cohort 1
Day 3 to Day 14 including end of study assessment.
|
Edaravone Single Dose Under Fasting Condition: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose 1 Hour After a High-fat Meal: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose 4 Hours After a High-fat Meal: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose Under Fasting Condition: White Conbined
White combined
|
Japanese
n=34 Participants
Japanese: Edaravone single dose under fasting condition
|
White
White: Edaravone single dose under fasting condition
|
Edaravone Single Dose 4 Hours After a High-fat Meal
Japanese combined
|
Edaravone + Rosuvastatin: Group 1 of Cohort 1
Day 9 to Day 11. The subjects receive edaravone from Day 6 to 11 with co-administration of rosuvastatin on Day 9.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
T1/2 of Glucuronide Conjugate.
Day 3: Group 2 (Edaravone alone)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
3.65 h
Standard Deviation 0.28
|
—
|
—
|
—
|
|
T1/2 of Glucuronide Conjugate.
Day 6: Group 2 (Edaravone + Furosemide)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
3.97 h
Standard Deviation 0.31
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Before dosing, and 0.083, 0.25, 0.5 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours post-dosePopulation: This study was conducted in 2 cohorts; the first cohort assessed DDIs with multiple doses of oral edaravone, and the second cohort evaluated PK and racial differences in PK parameters with oral administration of edaravone. Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
Outcome measures
| Measure |
Edaravone + Sildenafil: Group 1 of Cohort 1
Day 12 to Day 20 including end of study assessment. The subjects receive edaravone from Day 12 and 13 with co-administration of sildenafil on Day 12.
|
Combined: After Day 6: Group 1 of Cohort 1
Day 6 to Day 20 including end of study assessment.
|
Furosemide Alone: Group 2 of Cohort 1
Day 1 to Day 2. The subjects receive a single dose of furosemide on Day 1.
|
Edaravone Alone: Group 2 of Cohort 1
Day 3 to Day 5. The subjects receive a single dose of edaravone from Day 3 to Day 5.
|
Edaravone + Furosemide: Group 2 of Cohort 1
Day 6 to Day 14 including end of study assessment. The subjects receive edaravone on Day 6 to Day 7 with co-administration of furosemide on Day 6.
|
Combined : After Day 3: Group 2 of Cohort 1
Day 3 to Day 14 including end of study assessment.
|
Edaravone Single Dose Under Fasting Condition: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose 1 Hour After a High-fat Meal: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose 4 Hours After a High-fat Meal: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose Under Fasting Condition: White Conbined
White combined
|
Japanese
n=9 Participants
Japanese: Edaravone single dose under fasting condition
|
White
n=9 Participants
White: Edaravone single dose under fasting condition
|
Edaravone Single Dose 4 Hours After a High-fat Meal
n=9 Participants
Japanese combined
|
Edaravone + Rosuvastatin: Group 1 of Cohort 1
Day 9 to Day 11. The subjects receive edaravone from Day 6 to 11 with co-administration of rosuvastatin on Day 9.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUC0-inf of Unchanged Edaravone.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1647 ng*h/mL
Standard Deviation 433
|
1475 ng*h/mL
Standard Deviation 658
|
1247 ng*h/mL
Standard Deviation 425
|
—
|
PRIMARY outcome
Timeframe: Before dosing, and 0.083, 0.25, 0.5 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours post-dosePopulation: This study was conducted in 2 cohorts; the first cohort assessed DDIs with multiple doses of oral edaravone, and the second cohort evaluated PK and racial differences in PK parameters with oral administration of edaravone. Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
Outcome measures
| Measure |
Edaravone + Sildenafil: Group 1 of Cohort 1
Day 12 to Day 20 including end of study assessment. The subjects receive edaravone from Day 12 and 13 with co-administration of sildenafil on Day 12.
|
Combined: After Day 6: Group 1 of Cohort 1
Day 6 to Day 20 including end of study assessment.
|
Furosemide Alone: Group 2 of Cohort 1
Day 1 to Day 2. The subjects receive a single dose of furosemide on Day 1.
|
Edaravone Alone: Group 2 of Cohort 1
Day 3 to Day 5. The subjects receive a single dose of edaravone from Day 3 to Day 5.
|
Edaravone + Furosemide: Group 2 of Cohort 1
Day 6 to Day 14 including end of study assessment. The subjects receive edaravone on Day 6 to Day 7 with co-administration of furosemide on Day 6.
|
Combined : After Day 3: Group 2 of Cohort 1
Day 3 to Day 14 including end of study assessment.
|
Edaravone Single Dose Under Fasting Condition: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose 1 Hour After a High-fat Meal: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose 4 Hours After a High-fat Meal: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose Under Fasting Condition: White Conbined
White combined
|
Japanese
n=9 Participants
Japanese: Edaravone single dose under fasting condition
|
White
n=9 Participants
White: Edaravone single dose under fasting condition
|
Edaravone Single Dose 4 Hours After a High-fat Meal
n=9 Participants
Japanese combined
|
Edaravone + Rosuvastatin: Group 1 of Cohort 1
Day 9 to Day 11. The subjects receive edaravone from Day 6 to 11 with co-administration of rosuvastatin on Day 9.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax of Unchanged Edaravone.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1810 ng/mL
Standard Deviation 849.8
|
1502 ng/mL
Standard Deviation 1272
|
1012 ng/mL
Standard Deviation 603.3
|
—
|
PRIMARY outcome
Timeframe: Before dosing, and 0.083, 0.25, 0.5 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours post-dosePopulation: This study was conducted in 2 cohorts; the first cohort assessed DDIs with multiple doses of oral edaravone, and the second cohort evaluated PK and racial differences in PK parameters with oral administration of edaravone. Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
Outcome measures
| Measure |
Edaravone + Sildenafil: Group 1 of Cohort 1
Day 12 to Day 20 including end of study assessment. The subjects receive edaravone from Day 12 and 13 with co-administration of sildenafil on Day 12.
|
Combined: After Day 6: Group 1 of Cohort 1
Day 6 to Day 20 including end of study assessment.
|
Furosemide Alone: Group 2 of Cohort 1
Day 1 to Day 2. The subjects receive a single dose of furosemide on Day 1.
|
Edaravone Alone: Group 2 of Cohort 1
Day 3 to Day 5. The subjects receive a single dose of edaravone from Day 3 to Day 5.
|
Edaravone + Furosemide: Group 2 of Cohort 1
Day 6 to Day 14 including end of study assessment. The subjects receive edaravone on Day 6 to Day 7 with co-administration of furosemide on Day 6.
|
Combined : After Day 3: Group 2 of Cohort 1
Day 3 to Day 14 including end of study assessment.
|
Edaravone Single Dose Under Fasting Condition: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose 1 Hour After a High-fat Meal: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose 4 Hours After a High-fat Meal: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose Under Fasting Condition: White Conbined
White combined
|
Japanese
n=9 Participants
Japanese: Edaravone single dose under fasting condition
|
White
n=9 Participants
White: Edaravone single dose under fasting condition
|
Edaravone Single Dose 4 Hours After a High-fat Meal
n=9 Participants
Japanese combined
|
Edaravone + Rosuvastatin: Group 1 of Cohort 1
Day 9 to Day 11. The subjects receive edaravone from Day 6 to 11 with co-administration of rosuvastatin on Day 9.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Tmax of Unchanged Edaravone.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.25 h
Interval 0.25 to 1.0
|
0.50 h
Interval 0.25 to 1.5
|
0.25 h
Interval 0.25 to 1.0
|
—
|
PRIMARY outcome
Timeframe: Before dosing, and 0.083, 0.25, 0.5 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours post-dosePopulation: This study was conducted in 2 cohorts; the first cohort assessed DDIs with multiple doses of oral edaravone, and the second cohort evaluated PK and racial differences in PK parameters with oral administration of edaravone. Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
Outcome measures
| Measure |
Edaravone + Sildenafil: Group 1 of Cohort 1
Day 12 to Day 20 including end of study assessment. The subjects receive edaravone from Day 12 and 13 with co-administration of sildenafil on Day 12.
|
Combined: After Day 6: Group 1 of Cohort 1
Day 6 to Day 20 including end of study assessment.
|
Furosemide Alone: Group 2 of Cohort 1
Day 1 to Day 2. The subjects receive a single dose of furosemide on Day 1.
|
Edaravone Alone: Group 2 of Cohort 1
Day 3 to Day 5. The subjects receive a single dose of edaravone from Day 3 to Day 5.
|
Edaravone + Furosemide: Group 2 of Cohort 1
Day 6 to Day 14 including end of study assessment. The subjects receive edaravone on Day 6 to Day 7 with co-administration of furosemide on Day 6.
|
Combined : After Day 3: Group 2 of Cohort 1
Day 3 to Day 14 including end of study assessment.
|
Edaravone Single Dose Under Fasting Condition: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose 1 Hour After a High-fat Meal: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose 4 Hours After a High-fat Meal: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose Under Fasting Condition: White Conbined
White combined
|
Japanese
n=9 Participants
Japanese: Edaravone single dose under fasting condition
|
White
n=9 Participants
White: Edaravone single dose under fasting condition
|
Edaravone Single Dose 4 Hours After a High-fat Meal
n=9 Participants
Japanese combined
|
Edaravone + Rosuvastatin: Group 1 of Cohort 1
Day 9 to Day 11. The subjects receive edaravone from Day 6 to 11 with co-administration of rosuvastatin on Day 9.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
T1/2 of Unchanged Edaravone.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
9.33 h
Standard Deviation 4.87
|
9.65 h
Standard Deviation 5.41
|
7.66 h
Standard Deviation 4.12
|
—
|
PRIMARY outcome
Timeframe: Before dosing, and 0.083, 0.25, 0.5 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours post-dosePopulation: This study was conducted in 2 cohorts; the first cohort assessed DDIs with multiple doses of oral edaravone, and the second cohort evaluated PK and racial differences in PK parameters with oral administration of edaravone. Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
Outcome measures
| Measure |
Edaravone + Sildenafil: Group 1 of Cohort 1
Day 12 to Day 20 including end of study assessment. The subjects receive edaravone from Day 12 and 13 with co-administration of sildenafil on Day 12.
|
Combined: After Day 6: Group 1 of Cohort 1
Day 6 to Day 20 including end of study assessment.
|
Furosemide Alone: Group 2 of Cohort 1
Day 1 to Day 2. The subjects receive a single dose of furosemide on Day 1.
|
Edaravone Alone: Group 2 of Cohort 1
Day 3 to Day 5. The subjects receive a single dose of edaravone from Day 3 to Day 5.
|
Edaravone + Furosemide: Group 2 of Cohort 1
Day 6 to Day 14 including end of study assessment. The subjects receive edaravone on Day 6 to Day 7 with co-administration of furosemide on Day 6.
|
Combined : After Day 3: Group 2 of Cohort 1
Day 3 to Day 14 including end of study assessment.
|
Edaravone Single Dose Under Fasting Condition: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose 1 Hour After a High-fat Meal: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose 4 Hours After a High-fat Meal: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose Under Fasting Condition: White Conbined
White combined
|
Japanese
n=9 Participants
Japanese: Edaravone single dose under fasting condition
|
White
n=9 Participants
White: Edaravone single dose under fasting condition
|
Edaravone Single Dose 4 Hours After a High-fat Meal
n=9 Participants
Japanese combined
|
Edaravone + Rosuvastatin: Group 1 of Cohort 1
Day 9 to Day 11. The subjects receive edaravone from Day 6 to 11 with co-administration of rosuvastatin on Day 9.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUCinf of Sulfate Conjugate and Glucuronide Conjugate.
Sulfate conjugate
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
24484 ng*h/mL
Standard Deviation 5861
|
22689 ng*h/mL
Standard Deviation 6334
|
23022 ng*h/mL
Standard Deviation 5094
|
—
|
|
AUCinf of Sulfate Conjugate and Glucuronide Conjugate.
Glucuronide conjugate
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
4178 ng*h/mL
Standard Deviation 873
|
4099 ng*h/mL
Standard Deviation 637
|
3557 ng*h/mL
Standard Deviation 879
|
—
|
PRIMARY outcome
Timeframe: Before dosing, and 0.083, 0.25, 0.5 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours post-dosePopulation: This study was conducted in 2 cohorts; the first cohort assessed DDIs with multiple doses of oral edaravone, and the second cohort evaluated PK and racial differences in PK parameters with oral administration of edaravone. Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
Outcome measures
| Measure |
Edaravone + Sildenafil: Group 1 of Cohort 1
Day 12 to Day 20 including end of study assessment. The subjects receive edaravone from Day 12 and 13 with co-administration of sildenafil on Day 12.
|
Combined: After Day 6: Group 1 of Cohort 1
Day 6 to Day 20 including end of study assessment.
|
Furosemide Alone: Group 2 of Cohort 1
Day 1 to Day 2. The subjects receive a single dose of furosemide on Day 1.
|
Edaravone Alone: Group 2 of Cohort 1
Day 3 to Day 5. The subjects receive a single dose of edaravone from Day 3 to Day 5.
|
Edaravone + Furosemide: Group 2 of Cohort 1
Day 6 to Day 14 including end of study assessment. The subjects receive edaravone on Day 6 to Day 7 with co-administration of furosemide on Day 6.
|
Combined : After Day 3: Group 2 of Cohort 1
Day 3 to Day 14 including end of study assessment.
|
Edaravone Single Dose Under Fasting Condition: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose 1 Hour After a High-fat Meal: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose 4 Hours After a High-fat Meal: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose Under Fasting Condition: White Conbined
White combined
|
Japanese
n=9 Participants
Japanese: Edaravone single dose under fasting condition
|
White
n=9 Participants
White: Edaravone single dose under fasting condition
|
Edaravone Single Dose 4 Hours After a High-fat Meal
n=9 Participants
Japanese combined
|
Edaravone + Rosuvastatin: Group 1 of Cohort 1
Day 9 to Day 11. The subjects receive edaravone from Day 6 to 11 with co-administration of rosuvastatin on Day 9.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax of Sulfate Conjugate and Glucuronide Conjugate.
Sulfate conjugate
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
8394 ng/mL
Standard Deviation 1609
|
7802 ng/mL
Standard Deviation 1556
|
8152 ng/mL
Standard Deviation 1731
|
—
|
|
Cmax of Sulfate Conjugate and Glucuronide Conjugate.
Glucuronide conjugate
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
2391 ng/mL
Standard Deviation 508
|
2176 ng/mL
Standard Deviation 475
|
1924 ng/mL
Standard Deviation 380
|
—
|
PRIMARY outcome
Timeframe: Before dosing, and 0.083, 0.25, 0.5 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours post-dosePopulation: This study was conducted in 2 cohorts; the first cohort assessed DDIs with multiple doses of oral edaravone, and the second cohort evaluated PK and racial differences in PK parameters with oral administration of edaravone. Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
Outcome measures
| Measure |
Edaravone + Sildenafil: Group 1 of Cohort 1
Day 12 to Day 20 including end of study assessment. The subjects receive edaravone from Day 12 and 13 with co-administration of sildenafil on Day 12.
|
Combined: After Day 6: Group 1 of Cohort 1
Day 6 to Day 20 including end of study assessment.
|
Furosemide Alone: Group 2 of Cohort 1
Day 1 to Day 2. The subjects receive a single dose of furosemide on Day 1.
|
Edaravone Alone: Group 2 of Cohort 1
Day 3 to Day 5. The subjects receive a single dose of edaravone from Day 3 to Day 5.
|
Edaravone + Furosemide: Group 2 of Cohort 1
Day 6 to Day 14 including end of study assessment. The subjects receive edaravone on Day 6 to Day 7 with co-administration of furosemide on Day 6.
|
Combined : After Day 3: Group 2 of Cohort 1
Day 3 to Day 14 including end of study assessment.
|
Edaravone Single Dose Under Fasting Condition: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose 1 Hour After a High-fat Meal: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose 4 Hours After a High-fat Meal: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose Under Fasting Condition: White Conbined
White combined
|
Japanese
n=9 Participants
Japanese: Edaravone single dose under fasting condition
|
White
n=9 Participants
White: Edaravone single dose under fasting condition
|
Edaravone Single Dose 4 Hours After a High-fat Meal
n=9 Participants
Japanese combined
|
Edaravone + Rosuvastatin: Group 1 of Cohort 1
Day 9 to Day 11. The subjects receive edaravone from Day 6 to 11 with co-administration of rosuvastatin on Day 9.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Tmax of Sulfate Conjugate and Glucuronide Conjugate.
Sulfate conjugate
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.67 h
Standard Deviation 0.25
|
0.91 h
Standard Deviation 0.39
|
0.72 h
Standard Deviation 0.26
|
—
|
|
Tmax of Sulfate Conjugate and Glucuronide Conjugate.
Glucuronide conjugate
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.53 h
Standard Deviation 0.20
|
0.76 h
Standard Deviation 0.35
|
0.72 h
Standard Deviation 0.26
|
—
|
PRIMARY outcome
Timeframe: Before dosing, and 0.083, 0.25, 0.5 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours post-dosePopulation: This study was conducted in 2 cohorts; the first cohort assessed DDIs with multiple doses of oral edaravone, and the second cohort evaluated PK and racial differences in PK parameters with oral administration of edaravone. Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
Outcome measures
| Measure |
Edaravone + Sildenafil: Group 1 of Cohort 1
Day 12 to Day 20 including end of study assessment. The subjects receive edaravone from Day 12 and 13 with co-administration of sildenafil on Day 12.
|
Combined: After Day 6: Group 1 of Cohort 1
Day 6 to Day 20 including end of study assessment.
|
Furosemide Alone: Group 2 of Cohort 1
Day 1 to Day 2. The subjects receive a single dose of furosemide on Day 1.
|
Edaravone Alone: Group 2 of Cohort 1
Day 3 to Day 5. The subjects receive a single dose of edaravone from Day 3 to Day 5.
|
Edaravone + Furosemide: Group 2 of Cohort 1
Day 6 to Day 14 including end of study assessment. The subjects receive edaravone on Day 6 to Day 7 with co-administration of furosemide on Day 6.
|
Combined : After Day 3: Group 2 of Cohort 1
Day 3 to Day 14 including end of study assessment.
|
Edaravone Single Dose Under Fasting Condition: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose 1 Hour After a High-fat Meal: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose 4 Hours After a High-fat Meal: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose Under Fasting Condition: White Conbined
White combined
|
Japanese
n=9 Participants
Japanese: Edaravone single dose under fasting condition
|
White
n=9 Participants
White: Edaravone single dose under fasting condition
|
Edaravone Single Dose 4 Hours After a High-fat Meal
n=9 Participants
Japanese combined
|
Edaravone + Rosuvastatin: Group 1 of Cohort 1
Day 9 to Day 11. The subjects receive edaravone from Day 6 to 11 with co-administration of rosuvastatin on Day 9.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
T1/2 of Sulfate Conjugate and Glucuronide Conjugate.
Sulfate conjugate
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
10.50 h
Standard Deviation 7.67
|
7.53 h
Standard Deviation 3.55
|
7.55 h
Standard Deviation 2.47
|
—
|
|
T1/2 of Sulfate Conjugate and Glucuronide Conjugate.
Glucuronide conjugate
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
4.26 h
Standard Deviation 0.38
|
3.89 h
Standard Deviation 0.79
|
3.88 h
Standard Deviation 0.55
|
—
|
PRIMARY outcome
Timeframe: Before dosing, and 0.083, 0.25, 0.5 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours post-doseOutcome measures
| Measure |
Edaravone + Sildenafil: Group 1 of Cohort 1
Day 12 to Day 20 including end of study assessment. The subjects receive edaravone from Day 12 and 13 with co-administration of sildenafil on Day 12.
|
Combined: After Day 6: Group 1 of Cohort 1
Day 6 to Day 20 including end of study assessment.
|
Furosemide Alone: Group 2 of Cohort 1
Day 1 to Day 2. The subjects receive a single dose of furosemide on Day 1.
|
Edaravone Alone: Group 2 of Cohort 1
Day 3 to Day 5. The subjects receive a single dose of edaravone from Day 3 to Day 5.
|
Edaravone + Furosemide: Group 2 of Cohort 1
Day 6 to Day 14 including end of study assessment. The subjects receive edaravone on Day 6 to Day 7 with co-administration of furosemide on Day 6.
|
Combined : After Day 3: Group 2 of Cohort 1
Day 3 to Day 14 including end of study assessment.
|
Edaravone Single Dose Under Fasting Condition: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose 1 Hour After a High-fat Meal: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose 4 Hours After a High-fat Meal: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose Under Fasting Condition: White Conbined
White combined
|
Japanese
n=9 Participants
Japanese: Edaravone single dose under fasting condition
|
White
n=9 Participants
White: Edaravone single dose under fasting condition
|
Edaravone Single Dose 4 Hours After a High-fat Meal
Japanese combined
|
Edaravone + Rosuvastatin: Group 1 of Cohort 1
Day 9 to Day 11. The subjects receive edaravone from Day 6 to 11 with co-administration of rosuvastatin on Day 9.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
T1/2 of Glucuronide Conjugate.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
4.26 h
Standard Deviation 0.38
|
4.35 h
Standard Deviation 0.25
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 to 20 in group 1 of cohort 1, Day 1 to 14 in group 2 of cohort 1, Day 1 to 14 of cohort 2Population: This study was conducted in 2 cohorts; the first cohort assessed DDIs with multiple doses of oral edaravone, and the second cohort evaluated PK and racial differences in PK parameters with oral administration of edaravone. Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
Outcome measures
| Measure |
Edaravone + Sildenafil: Group 1 of Cohort 1
n=31 Participants
Day 12 to Day 20 including end of study assessment. The subjects receive edaravone from Day 12 and 13 with co-administration of sildenafil on Day 12.
|
Combined: After Day 6: Group 1 of Cohort 1
n=31 Participants
Day 6 to Day 20 including end of study assessment.
|
Furosemide Alone: Group 2 of Cohort 1
n=34 Participants
Day 1 to Day 2. The subjects receive a single dose of furosemide on Day 1.
|
Edaravone Alone: Group 2 of Cohort 1
n=34 Participants
Day 3 to Day 5. The subjects receive a single dose of edaravone from Day 3 to Day 5.
|
Edaravone + Furosemide: Group 2 of Cohort 1
n=34 Participants
Day 6 to Day 14 including end of study assessment. The subjects receive edaravone on Day 6 to Day 7 with co-administration of furosemide on Day 6.
|
Combined : After Day 3: Group 2 of Cohort 1
n=34 Participants
Day 3 to Day 14 including end of study assessment.
|
Edaravone Single Dose Under Fasting Condition: Japanese Conmibed
n=9 Participants
Japanese combined
|
Edaravone Single Dose 1 Hour After a High-fat Meal: Japanese Conmibed
n=9 Participants
Japanese combined
|
Edaravone Single Dose 4 Hours After a High-fat Meal: Japanese Conmibed
n=9 Participants
Japanese combined
|
Edaravone Single Dose Under Fasting Condition: White Conbined
n=9 Participants
White combined
|
Japanese
n=32 Participants
Japanese: Edaravone single dose under fasting condition
|
White
n=31 Participants
White: Edaravone single dose under fasting condition
|
Edaravone Single Dose 4 Hours After a High-fat Meal
n=31 Participants
Japanese combined
|
Edaravone + Rosuvastatin: Group 1 of Cohort 1
n=31 Participants
Day 9 to Day 11. The subjects receive edaravone from Day 6 to 11 with co-administration of rosuvastatin on Day 9.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events and Adverse Drug Reactions
Number of Participants with Adverse events
|
3 Participants
|
8 Participants
|
1 Participants
|
0 Participants
|
7 Participants
|
7 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
6 Participants
|
|
Number of Participants With Adverse Events and Adverse Drug Reactions
Number of Participants with adverse drug reactions
|
0 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Before dosing, and 0.083, 0.25, 0.5 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours post-dosePopulation: This study was conducted in 2 cohorts; the first cohort assessed DDIs with multiple doses of oral edaravone, and the second cohort evaluated PK and racial differences in PK parameters with oral administration of edaravone. 18 subjects (9 Japanese and 9 White) were enrolled in Cohort 2.
Outcome measures
| Measure |
Edaravone + Sildenafil: Group 1 of Cohort 1
Day 12 to Day 20 including end of study assessment. The subjects receive edaravone from Day 12 and 13 with co-administration of sildenafil on Day 12.
|
Combined: After Day 6: Group 1 of Cohort 1
Day 6 to Day 20 including end of study assessment.
|
Furosemide Alone: Group 2 of Cohort 1
Day 1 to Day 2. The subjects receive a single dose of furosemide on Day 1.
|
Edaravone Alone: Group 2 of Cohort 1
Day 3 to Day 5. The subjects receive a single dose of edaravone from Day 3 to Day 5.
|
Edaravone + Furosemide: Group 2 of Cohort 1
Day 6 to Day 14 including end of study assessment. The subjects receive edaravone on Day 6 to Day 7 with co-administration of furosemide on Day 6.
|
Combined : After Day 3: Group 2 of Cohort 1
Day 3 to Day 14 including end of study assessment.
|
Edaravone Single Dose Under Fasting Condition: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose 1 Hour After a High-fat Meal: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose 4 Hours After a High-fat Meal: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose Under Fasting Condition: White Conbined
White combined
|
Japanese
n=9 Participants
Japanese: Edaravone single dose under fasting condition
|
White
n=9 Participants
White: Edaravone single dose under fasting condition
|
Edaravone Single Dose 4 Hours After a High-fat Meal
Japanese combined
|
Edaravone + Rosuvastatin: Group 1 of Cohort 1
Day 9 to Day 11. The subjects receive edaravone from Day 6 to 11 with co-administration of rosuvastatin on Day 9.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUCinf of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate.
Unchanged edaravone
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1647 ng*h/mL
Standard Deviation 433
|
1423 ng*h/mL
Standard Deviation 391
|
—
|
—
|
|
AUCinf of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate.
Sulfate conjugate
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
24484 ng*h/mL
Standard Deviation 5861
|
20098 ng*h/mL
Standard Deviation 1592
|
—
|
—
|
|
AUCinf of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate.
Glucuronide conjugate
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
4178 ng*h/mL
Standard Deviation 873
|
3795 ng*h/mL
Standard Deviation 571
|
—
|
—
|
SECONDARY outcome
Timeframe: Before dosing, and 0.083, 0.25, 0.5 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours post-dosePopulation: This study was conducted in 2 cohorts; the first cohort assessed DDIs with multiple doses of oral edaravone, and the second cohort evaluated PK and racial differences in PK parameters with oral administration of edaravone. 18 subjects (9 Japanese and 9 White) were enrolled in Cohort 2.
Outcome measures
| Measure |
Edaravone + Sildenafil: Group 1 of Cohort 1
Day 12 to Day 20 including end of study assessment. The subjects receive edaravone from Day 12 and 13 with co-administration of sildenafil on Day 12.
|
Combined: After Day 6: Group 1 of Cohort 1
Day 6 to Day 20 including end of study assessment.
|
Furosemide Alone: Group 2 of Cohort 1
Day 1 to Day 2. The subjects receive a single dose of furosemide on Day 1.
|
Edaravone Alone: Group 2 of Cohort 1
Day 3 to Day 5. The subjects receive a single dose of edaravone from Day 3 to Day 5.
|
Edaravone + Furosemide: Group 2 of Cohort 1
Day 6 to Day 14 including end of study assessment. The subjects receive edaravone on Day 6 to Day 7 with co-administration of furosemide on Day 6.
|
Combined : After Day 3: Group 2 of Cohort 1
Day 3 to Day 14 including end of study assessment.
|
Edaravone Single Dose Under Fasting Condition: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose 1 Hour After a High-fat Meal: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose 4 Hours After a High-fat Meal: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose Under Fasting Condition: White Conbined
White combined
|
Japanese
n=9 Participants
Japanese: Edaravone single dose under fasting condition
|
White
n=9 Participants
White: Edaravone single dose under fasting condition
|
Edaravone Single Dose 4 Hours After a High-fat Meal
Japanese combined
|
Edaravone + Rosuvastatin: Group 1 of Cohort 1
Day 9 to Day 11. The subjects receive edaravone from Day 6 to 11 with co-administration of rosuvastatin on Day 9.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate.
Unchanged edaravone
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1810 ng/mL
Standard Deviation 850
|
1484 ng/mL
Standard Deviation 920
|
—
|
—
|
|
Cmax of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate.
Sulfate conjugate
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
8394 ng/mL
Standard Deviation 1609
|
6530 ng/mL
Standard Deviation 787
|
—
|
—
|
|
Cmax of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate.
Glucuronide conjugate
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
2391 ng/mL
Standard Deviation 508
|
2136 ng/mL
Standard Deviation 403
|
—
|
—
|
SECONDARY outcome
Timeframe: Before dosing, and 0.083, 0.25, 0.5 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours post-dosePopulation: This study was conducted in 2 cohorts; the first cohort assessed DDIs with multiple doses of oral edaravone, and the second cohort evaluated PK and racial differences in PK parameters with oral administration of edaravone. 18 subjects (9 Japanese and 9 White) were enrolled in Cohort 2.
Outcome measures
| Measure |
Edaravone + Sildenafil: Group 1 of Cohort 1
Day 12 to Day 20 including end of study assessment. The subjects receive edaravone from Day 12 and 13 with co-administration of sildenafil on Day 12.
|
Combined: After Day 6: Group 1 of Cohort 1
Day 6 to Day 20 including end of study assessment.
|
Furosemide Alone: Group 2 of Cohort 1
Day 1 to Day 2. The subjects receive a single dose of furosemide on Day 1.
|
Edaravone Alone: Group 2 of Cohort 1
Day 3 to Day 5. The subjects receive a single dose of edaravone from Day 3 to Day 5.
|
Edaravone + Furosemide: Group 2 of Cohort 1
Day 6 to Day 14 including end of study assessment. The subjects receive edaravone on Day 6 to Day 7 with co-administration of furosemide on Day 6.
|
Combined : After Day 3: Group 2 of Cohort 1
Day 3 to Day 14 including end of study assessment.
|
Edaravone Single Dose Under Fasting Condition: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose 1 Hour After a High-fat Meal: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose 4 Hours After a High-fat Meal: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose Under Fasting Condition: White Conbined
White combined
|
Japanese
n=9 Participants
Japanese: Edaravone single dose under fasting condition
|
White
n=9 Participants
White: Edaravone single dose under fasting condition
|
Edaravone Single Dose 4 Hours After a High-fat Meal
Japanese combined
|
Edaravone + Rosuvastatin: Group 1 of Cohort 1
Day 9 to Day 11. The subjects receive edaravone from Day 6 to 11 with co-administration of rosuvastatin on Day 9.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Tmax of Unchanged Edaravone.
Unchanged edaravone
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.4 h
Standard Deviation 0.3
|
0.4 h
Standard Deviation 0.2
|
—
|
—
|
|
Tmax of Unchanged Edaravone.
Sulfate conjugate
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.67 h
Standard Deviation 0.25
|
0.67 h
Standard Deviation 0.25
|
—
|
—
|
|
Tmax of Unchanged Edaravone.
Glucuronide conjugate
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.53 h
Standard Deviation 0.20
|
0.61 h
Standard Deviation 0.22
|
—
|
—
|
SECONDARY outcome
Timeframe: Before dosing, and 0.083, 0.25, 0.5 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours post-dosePopulation: This study was conducted in 2 cohorts; the first cohort assessed DDIs with multiple doses of oral edaravone, and the second cohort evaluated PK and racial differences in PK parameters with oral administration of edaravone. 18 subjects (9 Japanese and 9 White) were enrolled in Cohort 2.
Outcome measures
| Measure |
Edaravone + Sildenafil: Group 1 of Cohort 1
Day 12 to Day 20 including end of study assessment. The subjects receive edaravone from Day 12 and 13 with co-administration of sildenafil on Day 12.
|
Combined: After Day 6: Group 1 of Cohort 1
Day 6 to Day 20 including end of study assessment.
|
Furosemide Alone: Group 2 of Cohort 1
Day 1 to Day 2. The subjects receive a single dose of furosemide on Day 1.
|
Edaravone Alone: Group 2 of Cohort 1
Day 3 to Day 5. The subjects receive a single dose of edaravone from Day 3 to Day 5.
|
Edaravone + Furosemide: Group 2 of Cohort 1
Day 6 to Day 14 including end of study assessment. The subjects receive edaravone on Day 6 to Day 7 with co-administration of furosemide on Day 6.
|
Combined : After Day 3: Group 2 of Cohort 1
Day 3 to Day 14 including end of study assessment.
|
Edaravone Single Dose Under Fasting Condition: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose 1 Hour After a High-fat Meal: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose 4 Hours After a High-fat Meal: Japanese Conmibed
Japanese combined
|
Edaravone Single Dose Under Fasting Condition: White Conbined
White combined
|
Japanese
n=9 Participants
Japanese: Edaravone single dose under fasting condition
|
White
n=9 Participants
White: Edaravone single dose under fasting condition
|
Edaravone Single Dose 4 Hours After a High-fat Meal
Japanese combined
|
Edaravone + Rosuvastatin: Group 1 of Cohort 1
Day 9 to Day 11. The subjects receive edaravone from Day 6 to 11 with co-administration of rosuvastatin on Day 9.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
T1/2 of Unchanged Edaravone.
Unchanged edaravone
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
9.3 h
Standard Deviation 4.9
|
16.2 h
Standard Deviation 15.8
|
—
|
—
|
|
T1/2 of Unchanged Edaravone.
Sulfate conjugate
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
10.5 h
Standard Deviation 7.7
|
10.7 h
Standard Deviation 6.5
|
—
|
—
|
|
T1/2 of Unchanged Edaravone.
Glucuronide conjugate
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
4.3 h
Standard Deviation 0.4
|
4.4 h
Standard Deviation 0.3
|
—
|
—
|
Adverse Events
Edaravone Alone: Group 1 of Cohort 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Edaravone + Rosuvastatin: Group 1 of Cohort 1
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Edaravone + Sildenafil: Group 1 of Cohort 1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Combined: After Day 6: Group 1 of Cohort 1
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Furosemide Alone: Group 2 of Cohort 1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Edaravone Alone: Group 2 of Cohort 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Edaravone + Furosemide: Group 2 of Cohort 1
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Combined : After Day 3: Group 2 of Cohort 1
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Edaravone Single Dose Under Fasting Condition: Japanese Conmibed
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Edaravone Single Dose 1 Hour After a High-fat Meal: Japanese Conmibed
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Edaravone Single Dose 4 Hours After a High-fat Meal: Japanese Conmibed
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Edaravone Single Dose Under Fasting Condition: White Combined
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sildenafil Alone: Group 1 of Cohort 1
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Rosuvastatin Alone: Group 1 of Cohort 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Edaravone Alone: Group 1 of Cohort 1
n=31 participants at risk
Day 6 to Day 8. The subjects receive a single dose of edaravone from Day 6 to Day 8.
|
Edaravone + Rosuvastatin: Group 1 of Cohort 1
n=31 participants at risk
Day 9 to Day 11. The subjects receive edaravone from Day 6 to 11 with co-administration of rosuvastatin on Day 9.
|
Edaravone + Sildenafil: Group 1 of Cohort 1
n=31 participants at risk
Day 12 to Day 20 including end of study assessment. The subjects receive edaravone from Day 12 and 13 with co-administration of sildenafil on Day 12.
|
Combined: After Day 6: Group 1 of Cohort 1
n=31 participants at risk
Day 6 to Day 20 including end of study assessment.
|
Furosemide Alone: Group 2 of Cohort 1
n=34 participants at risk
Day 1 to Day 2. The subjects receive a single dose of furosemide on Day 1.
|
Edaravone Alone: Group 2 of Cohort 1
n=34 participants at risk
Day 3 to Day 5. The subjects receive a single dose of edaravone from Day 3 to Day 5.
|
Edaravone + Furosemide: Group 2 of Cohort 1
n=34 participants at risk
Day 6 to Day 14 including end of study assessment. The subjects receive edaravone on Day 6 to Day 7 with co-administration of furosemide on Day 6.
|
Combined : After Day 3: Group 2 of Cohort 1
n=34 participants at risk
Day 3 to Day 14 including end of study assessment.
|
Edaravone Single Dose Under Fasting Condition: Japanese Conmibed
n=9 participants at risk
Japanese combined
|
Edaravone Single Dose 1 Hour After a High-fat Meal: Japanese Conmibed
n=9 participants at risk
Japanese combined
|
Edaravone Single Dose 4 Hours After a High-fat Meal: Japanese Conmibed
n=9 participants at risk
Japanese combined
|
Edaravone Single Dose Under Fasting Condition: White Combined
n=9 participants at risk
White combined
|
Sildenafil Alone: Group 1 of Cohort 1
n=31 participants at risk
Day 4 to Day 5. The subjects receive a single dose of sildenafil on Day 4.
|
Rosuvastatin Alone: Group 1 of Cohort 1
n=32 participants at risk
Day 1 to Day 4. The subjects receive a single dose of rosuvastatin on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/31 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/31 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/31 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/31 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/34 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/34 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
14.7%
5/34 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
14.7%
5/34 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/9 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/9 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/9 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/9 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/31 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/32 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
|
Nervous system disorders
Headache
|
0.00%
0/31 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/31 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/31 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/31 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
2.9%
1/34 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/34 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
8.8%
3/34 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
8.8%
3/34 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/9 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/9 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/9 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/9 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
6.5%
2/31 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/32 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
|
Eye disorders
Abnormal sensation in eye
|
0.00%
0/31 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/31 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
3.2%
1/31 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
3.2%
1/31 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/34 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/34 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/34 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/34 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/9 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/9 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/9 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/9 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/31 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/32 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/31 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
3.2%
1/31 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/31 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
3.2%
1/31 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/34 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/34 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/34 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/34 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/9 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/9 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/9 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/9 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/31 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/32 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/31 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/31 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/31 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/31 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/34 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/34 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/34 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/34 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/9 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/9 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/9 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/9 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
3.2%
1/31 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/32 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/31 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
12.9%
4/31 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/31 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
12.9%
4/31 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/34 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/34 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/34 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/34 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/9 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/9 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/9 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/9 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/31 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/32 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/31 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
3.2%
1/31 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
6.5%
2/31 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
9.7%
3/31 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/34 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/34 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/34 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/34 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/9 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
22.2%
2/9 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/9 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/9 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/31 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/32 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/31 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
3.2%
1/31 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/31 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
3.2%
1/31 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/34 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/34 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/34 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/34 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/9 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
11.1%
1/9 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/9 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/9 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/31 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/32 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/31 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/31 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/31 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/31 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/34 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/34 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/34 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/34 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/9 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
11.1%
1/9 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/9 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/9 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/31 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/32 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/31 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/31 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/31 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/31 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/34 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/34 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/34 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/34 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/9 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
11.1%
1/9 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/9 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/9 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/31 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
0.00%
0/32 • Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.
This study was conducted in 2 cohorts; the first cohort assessed DDIs, and the second cohort evaluated PK and racial differences in PK parameters with oral edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2). Three groups of randomized Japanese subjects received a single dose of edaravone under each of 3 dosing meal conditions in a 3-way, 3-period crossover fashion (3X3) in Cohort 2.
|
Additional Information
Clinical Trials, Information Desk
Tanabe Pharma Corporation
Phone: Please e-mail
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER