NCT05342597 is a Phase 1 clinical trial of MT-1186 in Healthy Adult Subjects, sponsored by Tanabe Pharma Corporation.

Who is sponsoring NCT05342597?

NCT05342597 is sponsored by Tanabe Pharma Corporation.

What drugs are being tested in NCT05342597?

Interventions in NCT05342597: MT-1186.

What condition does NCT05342597 study?

NCT05342597 studies Healthy Adult Subjects.

Is NCT05342597 still recruiting?

NCT05342597 is currently completed. Last updated 7 January 2026.

Are results published for NCT05342597?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2026-01-07 · How we verify

NCT05342597

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Results posted Last updated 7 January 2026

What this trial tests

Phase 1 trial testing MT-1186 in Healthy Adult Subjects in 16 participants. Completed in 24 July 2019.

Timeline

10 June 2019

Primary endpoint
24 July 2019

24 July 2019

Quick facts

Lead sponsor	Tanabe Pharma Corporation
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	basic science
Enrollment	16
Start date	10 June 2019
Primary completion	24 July 2019
Estimated completion	24 July 2019
Sites	1 location across Japan

Drugs / interventions tested

MT-1186 — full drug profile →

Conditions studied

Healthy Adult Subjects — all drugs for Healthy Adult Subjects →

Sponsor

Tanabe Pharma Corporation — full company profile →

Who can join

Adults 20 to 45, any sex, with Healthy Adult Subjects. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Area Under the Concentration Versus Time Curve From Zero up to Infinity (AUC0-inf) of Edaravone Primary · 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

Group	Value	95% CI
Edaravone Single Dose Under Fasting Condition	2165	± 673
Edaravone Single Dose 8 Hours After a High-fat Meal	2209	± 658
Edaravone Single Dose 4 Hours After a Low-fat Meal	2073	± 641
Edaravone Single Dose 2 Hours After a Light Meal	1955	± 523
Edaravone Single Dose 2 Hours After a Low-fat Meal	1717	± 463

Maximum Plasma Concentration (Cmax) of Edaravone Primary · 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

Group	Value	95% CI
Edaravone Single Dose Under Fasting Condition	2318	± 1229
Edaravone Single Dose 8 Hours After a High-fat Meal	2525	± 1337
Edaravone Single Dose 4 Hours After a Low-fat Meal	2020	± 1114
Edaravone Single Dose 2 Hours After a Light Meal	1898	± 865.9
Edaravone Single Dose 2 Hours After a Low-fat Meal	1276	± 805.6

AUC0-inf of Sulfate Conjugate and Glucuronide Conjugate Primary · 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

Sulfate conjugate

Group	Value	95% CI
Edaravone Single Dose Under Fasting Condition	24519	± 7243
Edaravone Single Dose 8 Hours After a High-fat Meal	25724	± 7729
Edaravone Single Dose 4 Hours After a Low-fat Meal	24671	± 6077
Edaravone Single Dose 2 Hours After a Light Meal	25903	± 8657
Edaravone Single Dose 2 Hours After a Low-fat Meal	26293	± 10355

Glucuronide conjugate

Group	Value	95% CI
Edaravone Single Dose Under Fasting Condition	4054	± 791
Edaravone Single Dose 8 Hours After a High-fat Meal	3895	± 796
Edaravone Single Dose 4 Hours After a Low-fat Meal	4109	± 891
Edaravone Single Dose 2 Hours After a Light Meal	3914	± 841
Edaravone Single Dose 2 Hours After a Low-fat Meal	4325	± 1054

Cmax of Sulfate Conjugate and Glucuronide Conjugate Primary · 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

Sulfate conjugate

Group	Value	95% CI
Edaravone Single Dose Under Fasting Condition	8456	± 2041
Edaravone Single Dose 8 Hours After a High-fat Meal	9024	± 2430
Edaravone Single Dose 4 Hours After a Low-fat Meal	8629	± 1960
Edaravone Single Dose 2 Hours After a Light Meal	8665	± 2362
Edaravone Single Dose 2 Hours After a Low-fat Meal	7986	± 2288

Glucuronide conjugate

Group	Value	95% CI
Edaravone Single Dose Under Fasting Condition	2283	± 496.2
Edaravone Single Dose 8 Hours After a High-fat Meal	2209	± 645.9
Edaravone Single Dose 4 Hours After a Low-fat Meal	2283	± 486.7
Edaravone Single Dose 2 Hours After a Light Meal	2141	± 548.1
Edaravone Single Dose 2 Hours After a Low-fat Meal	2031	± 608.9

Time to Reach Maximum Plasma Concentration (Tmax) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate Primary · 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

Unchanged edaravone

Group	Value	95% CI
Edaravone Single Dose Under Fasting Condition	0.38	0.25 – 0.50
Edaravone Single Dose 8 Hours After a High-fat Meal	0.25	0.08 – 0.75
Edaravone Single Dose 4 Hours After a Low-fat Meal	0.50	0.25 – 0.75
Edaravone Single Dose 2 Hours After a Light Meal	0.38	0.25 – 1.00
Edaravone Single Dose 2 Hours After a Low-fat Meal	0.50	0.25 – 1.50

Sulfate conjugate

Group	Value	95% CI
Edaravone Single Dose Under Fasting Condition	0.75	0.50 – 0.75
Edaravone Single Dose 8 Hours After a High-fat Meal	0.63	0.50 – 1.00
Edaravone Single Dose 4 Hours After a Low-fat Meal	0.75	0.50 – 1.00
Edaravone Single Dose 2 Hours After a Light Meal	0.75	0.50 – 1.50
Edaravone Single Dose 2 Hours After a Low-fat Meal	1.00	0.75 – 1.50

Glucuronide conjugate

Group	Value	95% CI
Edaravone Single Dose Under Fasting Condition	0.50	0.50 – 1.00
Edaravone Single Dose 8 Hours After a High-fat Meal	0.50	0.50 – 1.00
Edaravone Single Dose 4 Hours After a Low-fat Meal	0.75	0.50 – 1.00
Edaravone Single Dose 2 Hours After a Light Meal	0.50	0.50 – 1.50
Edaravone Single Dose 2 Hours After a Low-fat Meal	0.75	0.50 – 1.00

Terminal Elimination Half-life (t1/2) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate Primary · 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

Unchanged edaravone

Group	Value	95% CI
Edaravone Single Dose Under Fasting Condition	8.17	± 2.29
Edaravone Single Dose 8 Hours After a High-fat Meal	7.38	± 1.97
Edaravone Single Dose 4 Hours After a Low-fat Meal	9.05	± 5.07
Edaravone Single Dose 2 Hours After a Light Meal	7.31	± 4.3
Edaravone Single Dose 2 Hours After a Low-fat Meal	11.25	± 8.35

Sulfate conjugate

Group	Value	95% CI
Edaravone Single Dose Under Fasting Condition	6.32	± 1.85
Edaravone Single Dose 8 Hours After a High-fat Meal	7.16	± 2.52
Edaravone Single Dose 4 Hours After a Low-fat Meal	5.85	± 1.18
Edaravone Single Dose 2 Hours After a Light Meal	6.25	± 1.69
Edaravone Single Dose 2 Hours After a Low-fat Meal	4.91	± 1.02

Glucuronide conjugate

Group	Value	95% CI
Edaravone Single Dose Under Fasting Condition	4.12	± 0.34
Edaravone Single Dose 8 Hours After a High-fat Meal	4.07	± 0.41
Edaravone Single Dose 4 Hours After a Low-fat Meal	4.12	± 0.46
Edaravone Single Dose 2 Hours After a Light Meal	4.03	± 0.7
Edaravone Single Dose 2 Hours After a Low-fat Meal	3.67	± 0.34

Apparent Terminal Elimination Rate Constant (Kel) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate Primary · 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

Unchanged edaravone

Group	Value	95% CI
Edaravone Single Dose Under Fasting Condition	0.0931	± 0.0343
Edaravone Single Dose 8 Hours After a High-fat Meal	0.0999	± 0.0248
Edaravone Single Dose 4 Hours After a Low-fat Meal	0.1010	± 0.0645
Edaravone Single Dose 2 Hours After a Light Meal	0.1108	± 0.0330
Edaravone Single Dose 2 Hours After a Low-fat Meal	0.0864	± 0.0435

Sulfate conjugate

Group	Value	95% CI
Edaravone Single Dose Under Fasting Condition	0.1164	± 0.0249
Edaravone Single Dose 8 Hours After a High-fat Meal	0.1062	± 0.0300
Edaravone Single Dose 4 Hours After a Low-fat Meal	0.1221	± 0.0195
Edaravone Single Dose 2 Hours After a Light Meal	0.1172	± 0.0246
Edaravone Single Dose 2 Hours After a Low-fat Meal	0.1463	± 0.0266

Glucuronide conjugate

Group	Value	95% CI
Edaravone Single Dose Under Fasting Condition	0.1690	± 0.0125
Edaravone Single Dose 8 Hours After a High-fat Meal	0.1720	± 0.0162
Edaravone Single Dose 4 Hours After a Low-fat Meal	0.1699	± 0.0173
Edaravone Single Dose 2 Hours After a Light Meal	0.1762	± 0.0254
Edaravone Single Dose 2 Hours After a Low-fat Meal	0.1905	± 0.0176

Mean Residence Time (MRT) of Unchanged Edaravone Primary · 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

Group	Value	95% CI
Edaravone Single Dose Under Fasting Condition	2.35	± 0.52
Edaravone Single Dose 8 Hours After a High-fat Meal	2.19	± 0.49
Edaravone Single Dose 4 Hours After a Low-fat Meal	2.34	± 0.44
Edaravone Single Dose 2 Hours After a Light Meal	2.32	± 0.54
Edaravone Single Dose 2 Hours After a Low-fat Meal	3.55	± 0.87

Apparent Total Clearance (CL/F) of Unchanged Edaravone Primary · 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

Group	Value	95% CI
Edaravone Single Dose Under Fasting Condition	53.0	± 16.3
Edaravone Single Dose 8 Hours After a High-fat Meal	51.4	± 14.4
Edaravone Single Dose 4 Hours After a Low-fat Meal	55.1	± 16.9
Edaravone Single Dose 2 Hours After a Light Meal	57.9	± 17.6
Edaravone Single Dose 2 Hours After a Low-fat Meal	65.4	± 17.3

Apparent Distribution Volume at Elimination Phase (Vz/F) of Unchanged Edaravone Primary · 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

Group	Value	95% CI
Edaravone Single Dose Under Fasting Condition	608	± 247
Edaravone Single Dose 8 Hours After a High-fat Meal	530	± 156
Edaravone Single Dose 4 Hours After a Low-fat Meal	646	± 239
Edaravone Single Dose 2 Hours After a Light Meal	585	± 305
Edaravone Single Dose 2 Hours After a Low-fat Meal	993	± 666

Apparent Distribution Volume at Steady State (Vss/F) of Unchanged Edaravone Primary · 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

Group	Value	95% CI
Edaravone Single Dose Under Fasting Condition	126.4	± 57.2
Edaravone Single Dose 8 Hours After a High-fat Meal	114.2	± 46.7
Edaravone Single Dose 4 Hours After a Low-fat Meal	128.6	± 41.6
Edaravone Single Dose 2 Hours After a Light Meal	136.1	± 59.0
Edaravone Single Dose 2 Hours After a Low-fat Meal	231.4	± 84.0

Cumulative Urinary Excretion Amount (Ae 0-24h) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate Primary · Day 1 to 9, Day 24 to 26

Unchanged edaravone

Group	Value	95% CI
Edaravone Single Dose Under Fasting Condition	0.819	± 0.349
Edaravone Single Dose 8 Hours After a High-fat Meal	1.609	± 2.630
Edaravone Single Dose 4 Hours After a Low-fat Meal	0.977	± 0.406
Edaravone Single Dose 2 Hours After a Light Meal	0.988	± 0.965
Edaravone Single Dose 2 Hours After a Low-fat Meal	1.302	± 2.086

Sulfate conjugate

Group	Value	95% CI
Edaravone Single Dose Under Fasting Condition	13.87	± 12.62
Edaravone Single Dose 8 Hours After a High-fat Meal	13.10	± 12.61
Edaravone Single Dose 4 Hours After a Low-fat Meal	13.13	± 13.99
Edaravone Single Dose 2 Hours After a Light Meal	13.14	± 10.96
Edaravone Single Dose 2 Hours After a Low-fat Meal	8.89	± 9.50

Glucuronide conjugate

Group	Value	95% CI
Edaravone Single Dose Under Fasting Condition	144.6	± 19.9
Edaravone Single Dose 8 Hours After a High-fat Meal	146.8	± 20.5
Edaravone Single Dose 4 Hours After a Low-fat Meal	144.0	± 18.4
Edaravone Single Dose 2 Hours After a Light Meal	153.2	± 22.6
Edaravone Single Dose 2 Hours After a Low-fat Meal	160.2	± 44.8

Adverse events — posted to ClinicalTrials.gov

Time frame: Day 1 to Day 31. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Edaravone Single Dose Under Fasting Condition

Serious: 0/16 (0%)

Deaths: 0/16

Edaravone Single Dose 8 Hours After a High-fat Meal

Serious: 0/16 (0%)

Deaths: 0/16

Edaravone Single Dose 4 Hours After a Low-fat Meal

Serious: 0/16 (0%)

Deaths: 0/16

Edaravone Single Dose 2 Hours After a Light Meal

Serious: 0/16 (0%)

Deaths: 0/16

Edaravone Single Dose 2 Hours After a Low-fat Meal

Serious: 0/16 (0%)

Deaths: 0/16

Other adverse events (1 terms — click to expand)

Reaction	System	Edaravone Single Dose Unde…	Edaravone Single Dose 8 Ho…	Edaravone Single Dose 4 Ho…	Edaravone Single Dose 2 Ho…	Edaravone Single Dose 2 Ho…
Urticaria	Skin and subcutaneous tissue disorders	—	—	—	—	—

Data from ClinicalTrials.gov NCT05342597 adverse events section.

Sponsor's own description

To evaluate the effect of food on the pharmacokinetics of oral edaravone in healthy adult subjects. In this study, we determined 5 different dietary conditions including 4 different meal contents and fasting condition.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Food Effect Study to Assess the Impact on Edaravone Pharmacokinetic Profiles in Healthy Participants.
Shimizu H, Nishimura Y, Shiide Y, Akimoto M, et al · · 2022 · cited 2× · PMID 36376130 · DOI 10.1016/j.clinthera.2022.10.001

Verify or expand the search:

Other trials of MT-1186

Trials testing the same drug.

NCT05568615 — Extension Study Following the Studies MT-1186-A03 or A04 to Evaluate the Safety of Oral Edaravone in Subjects With ALS · Phase 3 · completed
NCT05151471 — Efficacy and Safety Extension Study of Oral Edaravone Administered in Subjects With ALS · Phase 3 · terminated
NCT04776135 — Comparative Bioavailability Study of Oral Edaravone Administered Orally and Via a Nasogastric Tube · Phase 1 · completed
NCT04569084 — Efficacy and Safety Study of Oral Edaravone Administered in Subjects With ALS · Phase 3 · terminated
NCT04577404 — Safety Extension Study of Oral Edaravone Administered in Subjects With Amyotrophic Lateral Sclerosis (ALS) · Phase 3 · completed

Other recruiting trials for Healthy Adult Subjects

Currently open trials in the same condition.

NCT06635226 — Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ID110521156 in Healthy Adult Subjects · Phase 1 · recruiting

Other Tanabe Pharma Corporation trials

Trials by the same sponsor.

NCT06994286 — The Purpose of This Study is to Investigate the Safety, Tolerability and Pharmacokinetics of MT-7117 in Healthy Subjects · Phase 1 · completed
NCT06482346 — Clinical Pharmacology Study of MT-3534 in Healthy Adult Male Volunteers · Phase 1 · completed
NCT06196905 — An Exploratory Study of MT-2990 in Patients With AAV · Phase 1 · completed
NCT05568615 — Extension Study Following the Studies MT-1186-A03 or A04 to Evaluate the Safety of Oral Edaravone in Subjects With ALS · Phase 3 · completed
NCT05396235 — A Clinical Pharmacology Study of MT-3921 in Healthy Adult Males · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05342597 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Tanabe Pharma Corporation
Last refreshed: 7 January 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05342597.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT05342597

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other trials of MT-1186

Other recruiting trials for Healthy Adult Subjects

Other Tanabe Pharma Corporation trials

Verify against primary sources