Trial Outcomes & Findings for Comparative Bioavailability Study of Oral Edaravone Administered Orally and Via a Nasogastric Tube (NCT NCT04776135)
NCT ID: NCT04776135
Last Updated: 2026-05-22
Results Overview
Area under the plasma concentration versus time curve from time zero up to the last quantifiable concentration time-point (AUC0-t) of edaravone, and Area under the plasma concentration versus time curve from time zero up to infinity with extrapolation of the terminal phase (AUC0-inf) of edaravone.
COMPLETED
PHASE1
36 participants
Plasma samples are collected: Day 1 and Day 4 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 and Day 5 at 24 and 36 hours; Day 3 and Day 6 at 48 hours after administration.
2026-05-22
Participant Flow
Participant milestones
| Measure |
MT-1186 Orally, Then MT-1186 Via a Nasogastric Tube (NGT)
Period 1: a single dose of Edaravone oral suspension orally. Period 2: a single dose of Edaravone oral suspension via a NGT.
|
MT-1186 Via NGT, Then MT-1186 Orally
Period 1: a single dose of Edaravone oral suspension via NGT. Period 2 : a single dose of Edaravone oral suspension orally.
|
|---|---|---|
|
Period 1
STARTED
|
18
|
18
|
|
Period 1
COMPLETED
|
18
|
18
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
|
Period 2
STARTED
|
18
|
18
|
|
Period 2
COMPLETED
|
18
|
18
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparative Bioavailability Study of Oral Edaravone Administered Orally and Via a Nasogastric Tube
Baseline characteristics by cohort
| Measure |
MT-1186 Orally, Then MT-1186 Via a Nasogastric Tube (NGT)
n=18 Participants
Period 1: a single dose of Edaravone oral suspension orally. Period 2: a single dose of Edaravone oral suspension via a NGT.
|
MT-1186 Via NGT, Then MT-1186 Orally
n=18 Participants
Period 1: a single dose of Edaravone oral suspension via NGT. Period 2 : a single dose of Edaravone oral suspension orally.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=2 Participants
|
18 Participants
n=4 Participants
|
36 Participants
n=6 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=2 Participants
|
6 Participants
n=4 Participants
|
12 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=2 Participants
|
12 Participants
n=4 Participants
|
24 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
18 Participants
n=2 Participants
|
18 Participants
n=4 Participants
|
36 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Plasma samples are collected: Day 1 and Day 4 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 and Day 5 at 24 and 36 hours; Day 3 and Day 6 at 48 hours after administration.Population: This study was designed as a 2-group, 2-period crossover study with the advance administration of edaravone orally group (Oral =\> NGT) with 18 subjects, and the advance administration of edaravone via NGT group (NGT =\> Oral) with 18 subjects to investigate the bioavailability between edaravone orally and via NGT.
Area under the plasma concentration versus time curve from time zero up to the last quantifiable concentration time-point (AUC0-t) of edaravone, and Area under the plasma concentration versus time curve from time zero up to infinity with extrapolation of the terminal phase (AUC0-inf) of edaravone.
Outcome measures
| Measure |
MT-1186 Orally
n=36 Participants
Subjects receive the edaravone oral suspension orally.
|
MT-1186 Via NGT
n=36 Participants
Subjects receive the edaravone oral suspension via NGT
|
|---|---|---|
|
Area Under the Concentration Versus Time Curve (AUC) of Edaravone
AUC0-t
|
2612 ng·h/mL
Standard Deviation 787
|
2592 ng·h/mL
Standard Deviation 866
|
|
Area Under the Concentration Versus Time Curve (AUC) of Edaravone
AUC0-inf
|
2657 ng·h/mL
Standard Deviation 801
|
2617 ng·h/mL
Standard Deviation 870
|
PRIMARY outcome
Timeframe: Plasma samples are collected: Day 1 and Day 4 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 and Day 5 at 24 and 36 hours; Day 3 and Day 6 at 48 hour after administration.Population: This study was designed as a 2-group, 2-period crossover study with the advance administration of edaravone orally group (Oral =\> NGT) with 18 subjects, and the advance administration of edaravone via NGT group (NGT =\> Oral) with 18 subjects to investigate the bioavailability between edaravone orally and via NGT.
Outcome measures
| Measure |
MT-1186 Orally
n=36 Participants
Subjects receive the edaravone oral suspension orally.
|
MT-1186 Via NGT
n=36 Participants
Subjects receive the edaravone oral suspension via NGT
|
|---|---|---|
|
Maximum Plasma Concentration (Cmax) of Edaravone
|
2470 ng/mL
Standard Deviation 839.8
|
2775 ng/mL
Standard Deviation 1444
|
PRIMARY outcome
Timeframe: Plasma samples are collected: Day 1 and Day 4 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 and Day 5 at 24 and 36 hours; Day 3 and Day 6 at 48 hour after administration.Population: This study was designed as a 2-group, 2-period crossover study with the advance administration of edaravone orally group (Oral =\> NGT) with 18 subjects, and the advance administration of edaravone via NGT group (NGT =\> Oral) with 18 subjects to investigate the bioavailability between edaravone orally and via NGT.
Outcome measures
| Measure |
MT-1186 Orally
n=36 Participants
Subjects receive the edaravone oral suspension orally.
|
MT-1186 Via NGT
n=36 Participants
Subjects receive the edaravone oral suspension via NGT
|
|---|---|---|
|
Time to Reach Maximum Plasma Concentration (Tmax) of Edaravone
|
0.50 h
Interval 0.25 to 0.5
|
0.25 h
Interval 0.08 to 1.0
|
PRIMARY outcome
Timeframe: Plasma samples are collected: Day 1 and Day 4 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 and Day 5 at 24 and 36 hours; Day 3 and Day 6 at 48 hour after administration.Population: This study was designed as a 2-group, 2-period crossover study with the advance administration of edaravone orally group (Oral =\> NGT) with 18 subjects, and the advance administration of edaravone via NGT group (NGT =\> Oral) with 18 subjects to investigate the bioavailability between edaravone orally and via NGT.
Outcome measures
| Measure |
MT-1186 Orally
n=36 Participants
Subjects receive the edaravone oral suspension orally.
|
MT-1186 Via NGT
n=36 Participants
Subjects receive the edaravone oral suspension via NGT
|
|---|---|---|
|
Terminal Elimination Half-life (t1/2) of Edaravone
|
21.52 h
Standard Deviation 33.83
|
13.53 h
Standard Deviation 13.81
|
PRIMARY outcome
Timeframe: Plasma samples are collected: Day 1 and Day 4 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 and Day 5 at 24 and 36 hours; Day 3 and Day 6 at 48 hour after administration.Population: This study was designed as a 2-group, 2-period crossover study with the advance administration of edaravone orally group (Oral =\> NGT) with 18 subjects, and the advance administration of edaravone via NGT group (NGT =\> Oral) with 18 subjects to investigate the bioavailability between edaravone orally and via NGT.
Outcome measures
| Measure |
MT-1186 Orally
n=36 Participants
Subjects receive the edaravone oral suspension orally.
|
MT-1186 Via NGT
n=36 Participants
Subjects receive the edaravone oral suspension via NGT
|
|---|---|---|
|
Apparent Terminal Elimination Rate Constant (Kel) of Edaravone
|
0.06430 1/h
Standard Deviation 0.03776
|
0.07713 1/h
Standard Deviation 0.03269
|
PRIMARY outcome
Timeframe: Plasma samples are collected: Day 1 and Day 4 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 and Day 5 at 24 and 36 hours; Day 3 and Day 6 at 48 hour after administration.Population: This study was designed as a 2-group, 2-period crossover study with the advance administration of edaravone orally group (Oral =\> NGT) with 18 subjects, and the advance administration of edaravone via NGT group (NGT =\> Oral) with 18 subjects to investigate the bioavailability between edaravone orally and via NGT.
Outcome measures
| Measure |
MT-1186 Orally
n=36 Participants
Subjects receive the edaravone oral suspension orally.
|
MT-1186 Via NGT
n=36 Participants
Subjects receive the edaravone oral suspension via NGT
|
|---|---|---|
|
Mean Residence Time (MRT) of Edaravone
|
4.66 h
Standard Deviation 8.89
|
2.89 h
Standard Deviation 1.44
|
PRIMARY outcome
Timeframe: Plasma samples are collected: Day 1 and Day 4 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 and Day 5 at 24 and 36 hours; Day 3 and Day 6 at 48 hour after administration.Population: This study was designed as a 2-group, 2-period crossover study with the advance administration of edaravone orally group (Oral =\> NGT) with 18 subjects, and the advance administration of edaravone via NGT group (NGT =\> Oral) with 18 subjects to investigate the bioavailability between edaravone orally and via NGT.
Outcome measures
| Measure |
MT-1186 Orally
n=36 Participants
Subjects receive the edaravone oral suspension orally.
|
MT-1186 Via NGT
n=36 Participants
Subjects receive the edaravone oral suspension via NGT
|
|---|---|---|
|
Apparent Total Clearance (CL/F) of Edaravone
|
42.8 L/h
Standard Deviation 12.3
|
43.8 L/h
Standard Deviation 12.6
|
PRIMARY outcome
Timeframe: Plasma samples are collected: Day 1 and Day 4 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 and Day 5 at 24 and 36 hours; Day 3 and Day 6 at 48 hour after administration.Population: This study was designed as a 2-group, 2-period crossover study with the advance administration of edaravone orally group (Oral =\> NGT) with 18 subjects, and the advance administration of edaravone via NGT group (NGT =\> Oral) with 18 subjects to investigate the bioavailability between edaravone orally and via NGT.
Outcome measures
| Measure |
MT-1186 Orally
n=36 Participants
Subjects receive the edaravone oral suspension orally.
|
MT-1186 Via NGT
n=36 Participants
Subjects receive the edaravone oral suspension via NGT
|
|---|---|---|
|
Apparent Distribution Volume at Elimination Phase (Vz/F) of Edaravone
|
1209 L
Standard Deviation 1682
|
816 L
Standard Deviation 782
|
PRIMARY outcome
Timeframe: Plasma samples are collected: Day 1 and Day 4 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 and Day 5 at 24 and 36 hours; Day 3 and Day 6 at 48 hour after administration.Population: This study was designed as a 2-group, 2-period crossover study with the advance administration of edaravone orally group (Oral =\> NGT) with 18 subjects, and the advance administration of edaravone via NGT group (NGT =\> Oral) with 18 subjects to investigate the bioavailability between edaravone orally and via NGT.
Outcome measures
| Measure |
MT-1186 Orally
n=36 Participants
Subjects receive the edaravone oral suspension orally.
|
MT-1186 Via NGT
n=36 Participants
Subjects receive the edaravone oral suspension via NGT
|
|---|---|---|
|
Apparent Distribution Volume at Steady State (Vss/F) of Edaravone
|
183.7 L
Standard Deviation 299.9
|
125.4 L
Standard Deviation 67.7
|
SECONDARY outcome
Timeframe: Day 1 to 11Population: This study was designed as a 2-group, 2-period crossover study with the advance administration of edaravone orally group (Oral =\> NGT) with 18 subjects, and the advance administration of edaravone via NGT group (NGT =\> Oral) with 18 subjects to investigate the bioavailability between edaravone orally and via NGT.
Outcome measures
| Measure |
MT-1186 Orally
n=36 Participants
Subjects receive the edaravone oral suspension orally.
|
MT-1186 Via NGT
n=36 Participants
Subjects receive the edaravone oral suspension via NGT
|
|---|---|---|
|
Number of Participants With Adverse Events and Adverse Drug Reactions
Number of Participants with Adverse events
|
1 Participants
|
3 Participants
|
|
Number of Participants With Adverse Events and Adverse Drug Reactions
Number of Participants with adverse drug reactions
|
0 Participants
|
1 Participants
|
Adverse Events
MT-1186 Orally
MT-1186 Via NGT
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
MT-1186 Orally
n=36 participants at risk
Healthy subjects were administered a single dose of Edaravone oral suspension (105 mg) orally under fasted condition.
|
MT-1186 Via NGT
n=36 participants at risk
Healthy subjects were administered a single dose of Edaravone oral suspension (105 mg) via NGT under fasted condition.
|
|---|---|---|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/36 • The provision of informed consent to Day 11
This study was designed as a 2-group, 2-period crossover study with the advance administration of edaravone orally group (Oral =\> NGT) with 18 subjects, and the advance administration of edaravone via NGT group (NGT =\> Oral) with 18 subjects to investigate the bioavailability between edaravone orally and via NGT.
|
2.8%
1/36 • The provision of informed consent to Day 11
This study was designed as a 2-group, 2-period crossover study with the advance administration of edaravone orally group (Oral =\> NGT) with 18 subjects, and the advance administration of edaravone via NGT group (NGT =\> Oral) with 18 subjects to investigate the bioavailability between edaravone orally and via NGT.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/36 • The provision of informed consent to Day 11
This study was designed as a 2-group, 2-period crossover study with the advance administration of edaravone orally group (Oral =\> NGT) with 18 subjects, and the advance administration of edaravone via NGT group (NGT =\> Oral) with 18 subjects to investigate the bioavailability between edaravone orally and via NGT.
|
2.8%
1/36 • The provision of informed consent to Day 11
This study was designed as a 2-group, 2-period crossover study with the advance administration of edaravone orally group (Oral =\> NGT) with 18 subjects, and the advance administration of edaravone via NGT group (NGT =\> Oral) with 18 subjects to investigate the bioavailability between edaravone orally and via NGT.
|
|
Investigations
Blood creatinine increased
|
2.8%
1/36 • The provision of informed consent to Day 11
This study was designed as a 2-group, 2-period crossover study with the advance administration of edaravone orally group (Oral =\> NGT) with 18 subjects, and the advance administration of edaravone via NGT group (NGT =\> Oral) with 18 subjects to investigate the bioavailability between edaravone orally and via NGT.
|
0.00%
0/36 • The provision of informed consent to Day 11
This study was designed as a 2-group, 2-period crossover study with the advance administration of edaravone orally group (Oral =\> NGT) with 18 subjects, and the advance administration of edaravone via NGT group (NGT =\> Oral) with 18 subjects to investigate the bioavailability between edaravone orally and via NGT.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/36 • The provision of informed consent to Day 11
This study was designed as a 2-group, 2-period crossover study with the advance administration of edaravone orally group (Oral =\> NGT) with 18 subjects, and the advance administration of edaravone via NGT group (NGT =\> Oral) with 18 subjects to investigate the bioavailability between edaravone orally and via NGT.
|
2.8%
1/36 • The provision of informed consent to Day 11
This study was designed as a 2-group, 2-period crossover study with the advance administration of edaravone orally group (Oral =\> NGT) with 18 subjects, and the advance administration of edaravone via NGT group (NGT =\> Oral) with 18 subjects to investigate the bioavailability between edaravone orally and via NGT.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/36 • The provision of informed consent to Day 11
This study was designed as a 2-group, 2-period crossover study with the advance administration of edaravone orally group (Oral =\> NGT) with 18 subjects, and the advance administration of edaravone via NGT group (NGT =\> Oral) with 18 subjects to investigate the bioavailability between edaravone orally and via NGT.
|
5.6%
2/36 • The provision of informed consent to Day 11
This study was designed as a 2-group, 2-period crossover study with the advance administration of edaravone orally group (Oral =\> NGT) with 18 subjects, and the advance administration of edaravone via NGT group (NGT =\> Oral) with 18 subjects to investigate the bioavailability between edaravone orally and via NGT.
|
Additional Information
Clinical Trials, Information Desk
Tanabe Pharma Corporation
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER