Trial Outcomes & Findings for Clinical Pharmacology Study of Oral Edaravone in Healthy Adult Subjects (Food Effect Study) (NCT NCT05342597)

NCT ID: NCT05342597

Last Updated: 2026-01-07

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 16 participants
• Primary outcome timeframe: Before administration, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours after administration
• Results posted on: 2026-01-07

Participant Flow

Participant milestones

Measure	Group A A crossover study in which Japanese healthy subjects receive a single dose of MT-1186 under several dosing condition on Day 1, 3, 5, 7 and 24 according to their treatment sequence. MT-1186 orally dosing under fasted condition in period 1, dosing 8 hours after high-fat meal in period 2, dosing 4 hours after low-fat meal in period 3, dosing 2 hours after light meal in period 4, and dosing 2 hours after low-fat meal in period 5.	Group B A crossover study in which Japanese healthy subjects receive a single dose of MT-1186 under several dosing condition on Day 1, 3, 5, 7 and 24 according to their treatment sequence. MT-1186 orally dosing 8 hours after high-fat meal in period 1, dosing 4 hours after low-fat meal in period 2, dosing 2 hours after light meal in period 3, dosing under fasted condition in period 4 and dosing 2 hours after low-fat meal in period 5.	Group C A crossover study in which Japanese healthy subjects receive a single dose of MT-1186 under several dosing condition on Day 1, 3, 5, 7 and 24 according to their treatment sequence. MT-1186 orally dosing 4 hours after low-fat meal in period 1, dosing 2 hours after light meal in period 2, dosing under fasted condition in period 3, dosing 8 hours after high-fat meal in period 4 and dosing 2 hours after low-fat meal in period 5.	Group D A crossover study in which Japanese healthy subjects receive a single dose of MT-1186 under several dosing condition on Day 1, 3, 5, 7 and 24 according to their treatment sequence. MT-1186 orally dosing 2 hours after light meal in period 1, dosing under fasted condition in period 2, dosing 8 hours after high-fat meal in period 3, dosing 4 hours after low-fat meal in period 4 and dosing 2 hours after low-fat meal in period 5.
Period 1 STARTED	4	4	4	4
Period 1 COMPLETED	4	4	4	4
Period 1 NOT COMPLETED	0	0	0	0
Period 2 STARTED	4	4	4	4
Period 2 COMPLETED	4	4	4	4
Period 2 NOT COMPLETED	0	0	0	0
Period 3 STARTED	4	4	4	4
Period 3 COMPLETED	4	4	4	4
Period 3 NOT COMPLETED	0	0	0	0
Period 4 STARTED	4	4	4	4
Period 4 COMPLETED	4	4	4	4
Period 4 NOT COMPLETED	0	0	0	0
Period 5 STARTED	4	4	4	4
Period 5 COMPLETED	4	4	4	4
Period 5 NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Pharmacology Study of Oral Edaravone in Healthy Adult Subjects (Food Effect Study)

Baseline characteristics by cohort

Measure	Group A n=4 Participants A crossover study in which Japanese healthy subjects receive a single dose of MT-1186 under several dosing condition on Day 1, 3, 5, 7 and 24 according to their treatment sequence. MT-1186 orally dosing under fasted condition in period 1, dosing 8 hours after high-fat meal in period 2, dosing 4 hours after low-fat meal in period 3, dosing 2 hours after light meal in period 4, and dosing 2 hours after low-fat meal in period 5.	Group B n=4 Participants A crossover study in which Japanese healthy subjects receive a single dose of MT-1186 under several dosing condition on Day 1, 3, 5, 7 and 24 according to their treatment sequence. MT-1186 orally dosing 8 hours after high-fat meal in period 1, dosing 4 hours after low-fat meal in period 2, dosing 2 hours after light meal in period 3, dosing under fasted condition in period 4 and dosing 2 hours after low-fat meal in period 5.	Group C n=4 Participants A crossover study in which Japanese healthy subjects receive a single dose of MT-1186 under several dosing condition on Day 1, 3, 5, 7 and 24 according to their treatment sequence. MT-1186 orally dosing 4 hours after low-fat meal in period 1, dosing 2 hours after light meal in period 2, dosing under fasted condition in period 3, dosing 8 hours after high-fat meal in period 4 and dosing 2 hours after low-fat meal in period 5.	Group D n=4 Participants A crossover study in which Japanese healthy subjects receive a single dose of MT-1186 under several dosing condition on Day 1, 3, 5, 7 and 24 according to their treatment sequence. MT-1186 orally dosing 2 hours after light meal in period 1, dosing under fasted condition in period 2, dosing 8 hours after high-fat meal in period 3, dosing 4 hours after low-fat meal in period 4 and dosing 2 hours after low-fat meal in period 5.	Total n=16 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=37 Participants	0 Participants n=56 Participants	0 Participants n=95 Participants	0 Participants n=61 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=37 Participants	4 Participants n=56 Participants	4 Participants n=95 Participants	4 Participants n=61 Participants	16 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=37 Participants	0 Participants n=56 Participants	0 Participants n=95 Participants	0 Participants n=61 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=37 Participants	1 Participants n=56 Participants	1 Participants n=95 Participants	1 Participants n=61 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=37 Participants	3 Participants n=56 Participants	3 Participants n=95 Participants	3 Participants n=61 Participants	12 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=37 Participants	0 Participants n=56 Participants	0 Participants n=95 Participants	0 Participants n=61 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=37 Participants	4 Participants n=56 Participants	4 Participants n=95 Participants	4 Participants n=61 Participants	16 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=37 Participants	0 Participants n=56 Participants	0 Participants n=95 Participants	0 Participants n=61 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=37 Participants	0 Participants n=56 Participants	0 Participants n=95 Participants	0 Participants n=61 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=37 Participants	0 Participants n=56 Participants	0 Participants n=95 Participants	0 Participants n=61 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=37 Participants	0 Participants n=56 Participants	0 Participants n=95 Participants	0 Participants n=61 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=37 Participants	0 Participants n=56 Participants	0 Participants n=95 Participants	0 Participants n=61 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Before administration, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours after administration

Population: Four groups of randomized participants received edaravone oral suspension under 5 dosing conditions (4 subjects per group, 16 subjects per dosing condition).

Outcome measures

Measure	Edaravone Single Dose Under Fasting Condition n=16 Participants Subjects receive the edaravone oral suspension orally.	Edaravone Single Dose 8 Hours After a High-fat Meal n=16 Participants Subjects receive the edaravone oral suspension orally.	Edaravone Single Dose 4 Hours After a Low-fat Meal n=16 Participants Subjects receive the edaravone oral suspension orally.	Edaravone Single Dose 2 Hours After a Light Meal n=16 Participants Subjects receive the edaravone oral suspension orally.	Edaravone Single Dose 2 Hours After a Low-fat Meal n=16 Participants Subjects receive the edaravone oral suspension orally.
Area Under the Concentration Versus Time Curve From Zero up to Infinity (AUC0-inf) of Edaravone	2165 ng·h/mL Standard Deviation 673	2209 ng·h/mL Standard Deviation 658	2073 ng·h/mL Standard Deviation 641	1955 ng·h/mL Standard Deviation 523	1717 ng·h/mL Standard Deviation 463

PRIMARY outcome

Timeframe: Before administration, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours after administration

Population: Four groups of randomized participants received edaravone oral suspension under 5 dosing conditions (4 subjects per group, 16 subjects per dosing condition).

Outcome measures

Measure	Edaravone Single Dose Under Fasting Condition n=16 Participants Subjects receive the edaravone oral suspension orally.	Edaravone Single Dose 8 Hours After a High-fat Meal n=16 Participants Subjects receive the edaravone oral suspension orally.	Edaravone Single Dose 4 Hours After a Low-fat Meal n=16 Participants Subjects receive the edaravone oral suspension orally.	Edaravone Single Dose 2 Hours After a Light Meal n=16 Participants Subjects receive the edaravone oral suspension orally.	Edaravone Single Dose 2 Hours After a Low-fat Meal n=16 Participants Subjects receive the edaravone oral suspension orally.
Maximum Plasma Concentration (Cmax) of Edaravone	2318 ng/mL Standard Deviation 1229	2525 ng/mL Standard Deviation 1337	2020 ng/mL Standard Deviation 1114	1898 ng/mL Standard Deviation 865.9	1276 ng/mL Standard Deviation 805.6

PRIMARY outcome

Timeframe: Before administration, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours after administration

Population: Four groups of randomized participants received edaravone oral suspension under 5 dosing conditions (4 subjects per group, 16 subjects per dosing condition).

Outcome measures

Measure	Edaravone Single Dose Under Fasting Condition n=16 Participants Subjects receive the edaravone oral suspension orally.	Edaravone Single Dose 8 Hours After a High-fat Meal n=16 Participants Subjects receive the edaravone oral suspension orally.	Edaravone Single Dose 4 Hours After a Low-fat Meal n=16 Participants Subjects receive the edaravone oral suspension orally.	Edaravone Single Dose 2 Hours After a Light Meal n=16 Participants Subjects receive the edaravone oral suspension orally.	Edaravone Single Dose 2 Hours After a Low-fat Meal n=16 Participants Subjects receive the edaravone oral suspension orally.
AUC0-inf of Sulfate Conjugate and Glucuronide Conjugate Glucuronide conjugate	4054 ng·h/mL Standard Deviation 791	3895 ng·h/mL Standard Deviation 796	4109 ng·h/mL Standard Deviation 891	3914 ng·h/mL Standard Deviation 841	4325 ng·h/mL Standard Deviation 1054
AUC0-inf of Sulfate Conjugate and Glucuronide Conjugate Sulfate conjugate	24519 ng·h/mL Standard Deviation 7243	25724 ng·h/mL Standard Deviation 7729	24671 ng·h/mL Standard Deviation 6077	25903 ng·h/mL Standard Deviation 8657	26293 ng·h/mL Standard Deviation 10355

PRIMARY outcome

Timeframe: Before administration, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours after administration

Population: Four groups of randomized participants received edaravone oral suspension under 5 dosing conditions (4 subjects per group, 16 subjects per dosing condition).

Outcome measures

Measure	Edaravone Single Dose Under Fasting Condition n=16 Participants Subjects receive the edaravone oral suspension orally.	Edaravone Single Dose 8 Hours After a High-fat Meal n=16 Participants Subjects receive the edaravone oral suspension orally.	Edaravone Single Dose 4 Hours After a Low-fat Meal n=16 Participants Subjects receive the edaravone oral suspension orally.	Edaravone Single Dose 2 Hours After a Light Meal n=16 Participants Subjects receive the edaravone oral suspension orally.	Edaravone Single Dose 2 Hours After a Low-fat Meal n=16 Participants Subjects receive the edaravone oral suspension orally.
Cmax of Sulfate Conjugate and Glucuronide Conjugate Sulfate conjugate	8456 ng/mL Standard Deviation 2041	9024 ng/mL Standard Deviation 2430	8629 ng/mL Standard Deviation 1960	8665 ng/mL Standard Deviation 2362	7986 ng/mL Standard Deviation 2288
Cmax of Sulfate Conjugate and Glucuronide Conjugate Glucuronide conjugate	2283 ng/mL Standard Deviation 496.2	2209 ng/mL Standard Deviation 645.9	2283 ng/mL Standard Deviation 486.7	2141 ng/mL Standard Deviation 548.1	2031 ng/mL Standard Deviation 608.9

PRIMARY outcome

Timeframe: Before administration, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours after administration

Population: Four groups of randomized participants received edaravone oral suspension under 5 dosing conditions (4 subjects per group, 16 subjects per dosing condition).

Outcome measures

Measure	Edaravone Single Dose Under Fasting Condition n=16 Participants Subjects receive the edaravone oral suspension orally.	Edaravone Single Dose 8 Hours After a High-fat Meal n=16 Participants Subjects receive the edaravone oral suspension orally.	Edaravone Single Dose 4 Hours After a Low-fat Meal n=16 Participants Subjects receive the edaravone oral suspension orally.	Edaravone Single Dose 2 Hours After a Light Meal n=16 Participants Subjects receive the edaravone oral suspension orally.	Edaravone Single Dose 2 Hours After a Low-fat Meal n=16 Participants Subjects receive the edaravone oral suspension orally.
Time to Reach Maximum Plasma Concentration (Tmax) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate Unchanged edaravone	0.38 h Interval 0.25 to 0.5	0.25 h Interval 0.08 to 0.75	0.50 h Interval 0.25 to 0.75	0.38 h Interval 0.25 to 1.0	0.50 h Interval 0.25 to 1.5
Time to Reach Maximum Plasma Concentration (Tmax) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate Sulfate conjugate	0.75 h Interval 0.5 to 0.75	0.63 h Interval 0.5 to 1.0	0.75 h Interval 0.5 to 1.0	0.75 h Interval 0.5 to 1.5	1.00 h Interval 0.75 to 1.5
Time to Reach Maximum Plasma Concentration (Tmax) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate Glucuronide conjugate	0.50 h Interval 0.5 to 1.0	0.50 h Interval 0.5 to 1.0	0.75 h Interval 0.5 to 1.0	0.50 h Interval 0.5 to 1.5	0.75 h Interval 0.5 to 1.0

PRIMARY outcome

Timeframe: Before administration, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours after administration

Population: Four groups of randomized participants received edaravone oral suspension under 5 dosing conditions (4 subjects per group, 16 subjects per dosing condition).

Outcome measures

Measure	Edaravone Single Dose Under Fasting Condition n=16 Participants Subjects receive the edaravone oral suspension orally.	Edaravone Single Dose 8 Hours After a High-fat Meal n=16 Participants Subjects receive the edaravone oral suspension orally.	Edaravone Single Dose 4 Hours After a Low-fat Meal n=16 Participants Subjects receive the edaravone oral suspension orally.	Edaravone Single Dose 2 Hours After a Light Meal n=16 Participants Subjects receive the edaravone oral suspension orally.	Edaravone Single Dose 2 Hours After a Low-fat Meal n=16 Participants Subjects receive the edaravone oral suspension orally.
Terminal Elimination Half-life (t1/2) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate Unchanged edaravone	8.17 h Standard Deviation 2.29	7.38 h Standard Deviation 1.97	9.05 h Standard Deviation 5.07	7.31 h Standard Deviation 4.3	11.25 h Standard Deviation 8.35
Terminal Elimination Half-life (t1/2) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate Sulfate conjugate	6.32 h Standard Deviation 1.85	7.16 h Standard Deviation 2.52	5.85 h Standard Deviation 1.18	6.25 h Standard Deviation 1.69	4.91 h Standard Deviation 1.02
Terminal Elimination Half-life (t1/2) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate Glucuronide conjugate	4.12 h Standard Deviation 0.34	4.07 h Standard Deviation 0.41	4.12 h Standard Deviation 0.46	4.03 h Standard Deviation 0.7	3.67 h Standard Deviation 0.34

PRIMARY outcome

Timeframe: Before administration, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours after administration

Population: Four groups of randomized participants received edaravone oral suspension under 5 dosing conditions (4 subjects per group, 16 subjects per dosing condition).

Outcome measures

Measure	Edaravone Single Dose Under Fasting Condition n=16 Participants Subjects receive the edaravone oral suspension orally.	Edaravone Single Dose 8 Hours After a High-fat Meal n=16 Participants Subjects receive the edaravone oral suspension orally.	Edaravone Single Dose 4 Hours After a Low-fat Meal n=16 Participants Subjects receive the edaravone oral suspension orally.	Edaravone Single Dose 2 Hours After a Light Meal n=16 Participants Subjects receive the edaravone oral suspension orally.	Edaravone Single Dose 2 Hours After a Low-fat Meal n=16 Participants Subjects receive the edaravone oral suspension orally.
Apparent Terminal Elimination Rate Constant (Kel) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate Unchanged edaravone	0.0931 1/h Standard Deviation 0.0343	0.0999 1/h Standard Deviation 0.0248	0.1010 1/h Standard Deviation 0.0645	0.1108 1/h Standard Deviation 0.0330	0.0864 1/h Standard Deviation 0.0435
Apparent Terminal Elimination Rate Constant (Kel) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate Sulfate conjugate	0.1164 1/h Standard Deviation 0.0249	0.1062 1/h Standard Deviation 0.0300	0.1221 1/h Standard Deviation 0.0195	0.1172 1/h Standard Deviation 0.0246	0.1463 1/h Standard Deviation 0.0266
Apparent Terminal Elimination Rate Constant (Kel) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate Glucuronide conjugate	0.1690 1/h Standard Deviation 0.0125	0.1720 1/h Standard Deviation 0.0162	0.1699 1/h Standard Deviation 0.0173	0.1762 1/h Standard Deviation 0.0254	0.1905 1/h Standard Deviation 0.0176

PRIMARY outcome

Timeframe: Before administration, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours after administration

Population: Four groups of randomized participants received edaravone oral suspension under 5 dosing conditions (4 subjects per group, 16 subjects per dosing condition).

Outcome measures

Measure	Edaravone Single Dose Under Fasting Condition n=16 Participants Subjects receive the edaravone oral suspension orally.	Edaravone Single Dose 8 Hours After a High-fat Meal n=16 Participants Subjects receive the edaravone oral suspension orally.	Edaravone Single Dose 4 Hours After a Low-fat Meal n=16 Participants Subjects receive the edaravone oral suspension orally.	Edaravone Single Dose 2 Hours After a Light Meal n=16 Participants Subjects receive the edaravone oral suspension orally.	Edaravone Single Dose 2 Hours After a Low-fat Meal n=16 Participants Subjects receive the edaravone oral suspension orally.
Mean Residence Time (MRT) of Unchanged Edaravone	2.35 h Standard Deviation 0.52	2.19 h Standard Deviation 0.49	2.34 h Standard Deviation 0.44	2.32 h Standard Deviation 0.54	3.55 h Standard Deviation 0.87

PRIMARY outcome

Timeframe: Before administration, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours after administration

Population: Four groups of randomized participants received edaravone oral suspension under 5 dosing conditions (4 subjects per group, 16 subjects per dosing condition).

Outcome measures

Measure	Edaravone Single Dose Under Fasting Condition n=16 Participants Subjects receive the edaravone oral suspension orally.	Edaravone Single Dose 8 Hours After a High-fat Meal n=16 Participants Subjects receive the edaravone oral suspension orally.	Edaravone Single Dose 4 Hours After a Low-fat Meal n=16 Participants Subjects receive the edaravone oral suspension orally.	Edaravone Single Dose 2 Hours After a Light Meal n=16 Participants Subjects receive the edaravone oral suspension orally.	Edaravone Single Dose 2 Hours After a Low-fat Meal n=16 Participants Subjects receive the edaravone oral suspension orally.
Apparent Total Clearance (CL/F) of Unchanged Edaravone	53.0 L/h Standard Deviation 16.3	51.4 L/h Standard Deviation 14.4	55.1 L/h Standard Deviation 16.9	57.9 L/h Standard Deviation 17.6	65.4 L/h Standard Deviation 17.3

PRIMARY outcome

Timeframe: Before administration, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours after administration

Population: Four groups of randomized participants received edaravone oral suspension under 5 dosing conditions (4 subjects per group, 16 subjects per dosing condition).

Outcome measures

Measure	Edaravone Single Dose Under Fasting Condition n=16 Participants Subjects receive the edaravone oral suspension orally.	Edaravone Single Dose 8 Hours After a High-fat Meal n=16 Participants Subjects receive the edaravone oral suspension orally.	Edaravone Single Dose 4 Hours After a Low-fat Meal n=16 Participants Subjects receive the edaravone oral suspension orally.	Edaravone Single Dose 2 Hours After a Light Meal n=16 Participants Subjects receive the edaravone oral suspension orally.	Edaravone Single Dose 2 Hours After a Low-fat Meal n=16 Participants Subjects receive the edaravone oral suspension orally.
Apparent Distribution Volume at Elimination Phase (Vz/F) of Unchanged Edaravone	608 L Standard Deviation 247	530 L Standard Deviation 156	646 L Standard Deviation 239	585 L Standard Deviation 305	993 L Standard Deviation 666

PRIMARY outcome

Timeframe: Before administration, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours after administration

Population: Four groups of randomized participants received edaravone oral suspension under 5 dosing conditions (4 subjects per group, 16 subjects per dosing condition).

Outcome measures

Measure	Edaravone Single Dose Under Fasting Condition n=16 Participants Subjects receive the edaravone oral suspension orally.	Edaravone Single Dose 8 Hours After a High-fat Meal n=16 Participants Subjects receive the edaravone oral suspension orally.	Edaravone Single Dose 4 Hours After a Low-fat Meal n=16 Participants Subjects receive the edaravone oral suspension orally.	Edaravone Single Dose 2 Hours After a Light Meal n=16 Participants Subjects receive the edaravone oral suspension orally.	Edaravone Single Dose 2 Hours After a Low-fat Meal n=16 Participants Subjects receive the edaravone oral suspension orally.
Apparent Distribution Volume at Steady State (Vss/F) of Unchanged Edaravone	126.4 L Standard Deviation 57.2	114.2 L Standard Deviation 46.7	128.6 L Standard Deviation 41.6	136.1 L Standard Deviation 59.0	231.4 L Standard Deviation 84.0

PRIMARY outcome

Timeframe: Day 1 to 9, Day 24 to 26

Population: Four groups of randomized participants received edaravone oral suspension under 5 dosing conditions (4 subjects per group, 16 subjects per dosing condition).

Outcome measures

Measure	Edaravone Single Dose Under Fasting Condition n=16 Participants Subjects receive the edaravone oral suspension orally.	Edaravone Single Dose 8 Hours After a High-fat Meal n=16 Participants Subjects receive the edaravone oral suspension orally.	Edaravone Single Dose 4 Hours After a Low-fat Meal n=16 Participants Subjects receive the edaravone oral suspension orally.	Edaravone Single Dose 2 Hours After a Light Meal n=16 Participants Subjects receive the edaravone oral suspension orally.	Edaravone Single Dose 2 Hours After a Low-fat Meal n=16 Participants Subjects receive the edaravone oral suspension orally.
Cumulative Urinary Excretion Amount (Ae 0-24h) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate Unchanged edaravone	0.819 mg Standard Deviation 0.349	1.609 mg Standard Deviation 2.630	0.977 mg Standard Deviation 0.406	0.988 mg Standard Deviation 0.965	1.302 mg Standard Deviation 2.086
Cumulative Urinary Excretion Amount (Ae 0-24h) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate Sulfate conjugate	13.87 mg Standard Deviation 12.62	13.10 mg Standard Deviation 12.61	13.13 mg Standard Deviation 13.99	13.14 mg Standard Deviation 10.96	8.89 mg Standard Deviation 9.50
Cumulative Urinary Excretion Amount (Ae 0-24h) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate Glucuronide conjugate	144.6 mg Standard Deviation 19.9	146.8 mg Standard Deviation 20.5	144.0 mg Standard Deviation 18.4	153.2 mg Standard Deviation 22.6	160.2 mg Standard Deviation 44.8

PRIMARY outcome

Timeframe: Day 1 to 9, Day 24 to 26

Population: Four groups of randomized participants received edaravone oral suspension under 5 dosing conditions (4 subjects per group, 16 subjects per dosing condition).

Outcome measures

Measure	Edaravone Single Dose Under Fasting Condition n=16 Participants Subjects receive the edaravone oral suspension orally.	Edaravone Single Dose 8 Hours After a High-fat Meal n=16 Participants Subjects receive the edaravone oral suspension orally.	Edaravone Single Dose 4 Hours After a Low-fat Meal n=16 Participants Subjects receive the edaravone oral suspension orally.	Edaravone Single Dose 2 Hours After a Light Meal n=16 Participants Subjects receive the edaravone oral suspension orally.	Edaravone Single Dose 2 Hours After a Low-fat Meal n=16 Participants Subjects receive the edaravone oral suspension orally.
Urinary Excretion Ratio (Ae% 0-24h) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate Unchanged edaravone	0.780 % of dose Standard Deviation 0.349	1.533 % of dose Standard Deviation 2.505	0.931 % of dose Standard Deviation 0.386	0.941 % of dose Standard Deviation 0.919	1.240 % of dose Standard Deviation 1.986
Urinary Excretion Ratio (Ae% 0-24h) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate Sulfate conjugate	9.08 % of dose Standard Deviation 8.27	8.58 % of dose Standard Deviation 8.26	8.60 % of dose Standard Deviation 9.17	8.61 % of dose Standard Deviation 7.18	5.82 % of dose Standard Deviation 6.22
Urinary Excretion Ratio (Ae% 0-24h) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate Glucuronide conjugate	68.7 % of dose Standard Deviation 9.5	69.7 % of dose Standard Deviation 9.7	68.4 % of dose Standard Deviation 8.8	72.8 % of dose Standard Deviation 10.7	76.1 % of dose Standard Deviation 21.3

PRIMARY outcome

Timeframe: Day 1 to 9, Day 24 to 26

Population: Four groups of randomized participants received edaravone oral suspension under 5 dosing conditions (4 subjects per group, 16 subjects per dosing condition).

Outcome measures

Measure	Edaravone Single Dose Under Fasting Condition n=16 Participants Subjects receive the edaravone oral suspension orally.	Edaravone Single Dose 8 Hours After a High-fat Meal n=16 Participants Subjects receive the edaravone oral suspension orally.	Edaravone Single Dose 4 Hours After a Low-fat Meal n=16 Participants Subjects receive the edaravone oral suspension orally.	Edaravone Single Dose 2 Hours After a Light Meal n=16 Participants Subjects receive the edaravone oral suspension orally.	Edaravone Single Dose 2 Hours After a Low-fat Meal n=16 Participants Subjects receive the edaravone oral suspension orally.
Renal Clearance (CLr) of Unchanged Edaravone	0.419 L/h Standard Deviation 0.271	0.818 L/h Standard Deviation 1.413	0.535 L/h Standard Deviation 0.333	0.545 L/h Standard Deviation 0.535	0.871 L/h Standard Deviation 1.582

SECONDARY outcome

Timeframe: Day 1 to Day 31

Population: Four groups of randomized participants received edaravone oral suspension under 5 dosing conditions (4 subjects per group, 16 subjects per dosing condition).

Outcome measures

Measure	Edaravone Single Dose Under Fasting Condition n=16 Participants Subjects receive the edaravone oral suspension orally.	Edaravone Single Dose 8 Hours After a High-fat Meal n=16 Participants Subjects receive the edaravone oral suspension orally.	Edaravone Single Dose 4 Hours After a Low-fat Meal n=16 Participants Subjects receive the edaravone oral suspension orally.	Edaravone Single Dose 2 Hours After a Light Meal n=16 Participants Subjects receive the edaravone oral suspension orally.	Edaravone Single Dose 2 Hours After a Low-fat Meal n=16 Participants Subjects receive the edaravone oral suspension orally.
Number of Participants With Adverse Events and Adverse Drug Reactions Number of Participants with Adverse events	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events and Adverse Drug Reactions Number of Participants with adverse drug reactions	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

Adverse Events

Edaravone Single Dose Under Fasting Condition

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Edaravone Single Dose 8 Hours After a High-fat Meal

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Edaravone Single Dose 4 Hours After a Low-fat Meal

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Edaravone Single Dose 2 Hours After a Light Meal

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Edaravone Single Dose 2 Hours After a Low-fat Meal

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 Single Dose Under Fasting Condition n=16 participants at risk Subjects receive the edaravone oral suspension orally.	Edaravone Single Dose 8 Hours After a High-fat Meal n=16 participants at risk Subjects receive the edaravone oral suspension orally.	Edaravone Single Dose 4 Hours After a Low-fat Meal n=16 participants at risk Subjects receive the edaravone oral suspension orally.	Edaravone Single Dose 2 Hours After a Light Meal n=16 participants at risk Subjects receive the edaravone oral suspension orally.	Edaravone Single Dose 2 Hours After a Low-fat Meal n=16 participants at risk Subjects receive the edaravone oral suspension orally.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/16 • Day 1 to Day 31 Four groups of randomized participants received edaravone oral suspension under 5 dosing conditions (4 subjects per group, 16 subjects per dosing condition).	0.00% 0/16 • Day 1 to Day 31 Four groups of randomized participants received edaravone oral suspension under 5 dosing conditions (4 subjects per group, 16 subjects per dosing condition).	6.2% 1/16 • Day 1 to Day 31 Four groups of randomized participants received edaravone oral suspension under 5 dosing conditions (4 subjects per group, 16 subjects per dosing condition).	0.00% 0/16 • Day 1 to Day 31 Four groups of randomized participants received edaravone oral suspension under 5 dosing conditions (4 subjects per group, 16 subjects per dosing condition).	0.00% 0/16 • Day 1 to Day 31 Four groups of randomized participants received edaravone oral suspension under 5 dosing conditions (4 subjects per group, 16 subjects per dosing condition).

Additional Information

Clinical Trials, Information Desk

Tanabe Pharma Corporation

Phone: Please email

Email: cti-inq-ml.JP@ml.tanabe-pharma.com

Results disclosure agreements

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

Restriction type: OTHER