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To evaluate the pharmacokinetics of single doses of edaravone oral suspension in Patients with Amyotrophic Lateral Sclerosis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MT-1186 | Experimental | Patients receive the edaravone oral suspension. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MT-1186 | Drug | Suspension |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration Versus Time Curve From Time Zero up to the Last Quantifiable Concentration Time-point (AUC0-t) of Unchanged Edaravone | Plasma samples are collected: Day 1 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 at 24 hours after administration. | |
| Maximum Plasma Concentration (Cmax) of Unchanged Edaravone | Plasma samples are collected: Day 1 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 at 24 hours after administration. | |
| Time to Reach Maximum Plasma Concentration (Tmax) of Unchanged Edaravone | Plasma samples are collected: Day 1 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 at 24 hours after administration. | |
| Terminal Elimination Half-life (t1/2) of Unchanged Edaravone | Plasma samples are collected: Day 1 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 at 24 hours after administration. | |
| Apparent Terminal Elimination Rate Constant (Kel) of Unchanged Edaravone | Plasma samples are collected: Day 1 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 at 24 hours after administration. | |
| Mean Residence Time (MRT) of Unchanged Edaravone | Plasma samples are collected: Day 1 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 at 24 hours after administration. | |
| Apparent Total Clearance (CL/F) of Unchanged Edaravone | Plasma samples are collected: Day 1 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 at 24 hours after administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events and Adverse Drug Reactions | Day 1 to 8 |
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Inclusion Criteria:
The key criteria are listed below.
Exclusion Criteria:
The key criteria are listed below.
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| Name | Affiliation | Role |
|---|---|---|
| General Manager | Tanabe Pharma Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational site | Tokyo | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37953075 | Derived | Shimizu H, Nishimura Y, Shiide Y, Akimoto M, Yashiro M, Ueda M, Hirai M, Yoshino H, Mizutani T, Kanai K, Kano O, Kimura H, Sekino H, Ito K. Pharmacokinetics of Edaravone Oral Suspension in Patients With Amyotrophic Lateral Sclerosis. Clin Ther. 2023 Dec;45(12):1251-1258. doi: 10.1016/j.clinthera.2023.09.025. Epub 2023 Nov 11. |
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| ID | Title | Description |
|---|---|---|
| FG000 | MT-1186 | ALS patients receive the edaravone oral suspension. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | MT-1186 | ALS patients receive the edaravone oral suspension. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Area Under the Plasma Concentration Versus Time Curve From Time Zero up to the Last Quantifiable Concentration Time-point (AUC0-t) of Unchanged Edaravone | Posted | Mean | Standard Deviation | ng·h/mL | Plasma samples are collected: Day 1 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 at 24 hours after administration. |
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Day 1 to Day 8
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MT-1186 | ALS patients receive the edaravone oral suspension. | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood urine present | Investigations | MedDRA 22.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials, Information Desk | Tanabe Pharma Corporation | Please email | cti-inq-ml.JP@ml.tanabe-pharma.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 13, 2019 | Apr 18, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 28, 2019 | Apr 18, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000077553 | Edaravone |
| ID | Term |
|---|---|
| D000983 | Antipyrine |
| D047069 | Pyrazolones |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 |
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| Apparent Distribution Volume at Elimination Phase (Vz/F) of Unchanged Edaravone | Plasma samples are collected: Day 1 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 at 24 hours after administration. |
| Apparent Distribution Volume at Steady State (Vss/F) of Unchanged Edaravone | Plasma samples are collected: Day 1 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 at 24 hours after administration. |
| Cumulative Amount of Drug Excreted in Urine From Time Zero up to 24 Hours (Ae0-24) of Unchanged Edaravone | Urine samples are collected: 0 to 24 hours after oral administration |
| Cumulative Percentage of Drug Excreted in Urine From Time Zero up to 24 Hours (Ae0-24) of Unchanged Edaravone | Urine samples are collected: 0 to 24 hours after oral administration |
| Renal Clearance (CLr) of Unchanged Edaravone | Urine samples are collected: 0 to 24 hours after oral administration |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Primary | Maximum Plasma Concentration (Cmax) of Unchanged Edaravone | Posted | Mean | Standard Deviation | ng/mL | Plasma samples are collected: Day 1 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 at 24 hours after administration. |
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| Primary | Time to Reach Maximum Plasma Concentration (Tmax) of Unchanged Edaravone | Posted | Median | Full Range | h | Plasma samples are collected: Day 1 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 at 24 hours after administration. |
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| Primary | Terminal Elimination Half-life (t1/2) of Unchanged Edaravone | Posted | Mean | Standard Deviation | h | Plasma samples are collected: Day 1 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 at 24 hours after administration. |
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| Primary | Apparent Terminal Elimination Rate Constant (Kel) of Unchanged Edaravone | Posted | Mean | Standard Deviation | 1/h | Plasma samples are collected: Day 1 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 at 24 hours after administration. |
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| Primary | Mean Residence Time (MRT) of Unchanged Edaravone | Posted | Mean | Standard Deviation | h | Plasma samples are collected: Day 1 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 at 24 hours after administration. |
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| Primary | Apparent Total Clearance (CL/F) of Unchanged Edaravone | Posted | Mean | Standard Deviation | L/h | Plasma samples are collected: Day 1 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 at 24 hours after administration. |
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| Primary | Apparent Distribution Volume at Elimination Phase (Vz/F) of Unchanged Edaravone | Posted | Mean | Standard Deviation | L | Plasma samples are collected: Day 1 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 at 24 hours after administration. |
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| Primary | Apparent Distribution Volume at Steady State (Vss/F) of Unchanged Edaravone | Posted | Mean | Standard Deviation | L | Plasma samples are collected: Day 1 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 at 24 hours after administration. |
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| Primary | Cumulative Amount of Drug Excreted in Urine From Time Zero up to 24 Hours (Ae0-24) of Unchanged Edaravone | Posted | Mean | Standard Deviation | mg | Urine samples are collected: 0 to 24 hours after oral administration |
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| Primary | Cumulative Percentage of Drug Excreted in Urine From Time Zero up to 24 Hours (Ae0-24) of Unchanged Edaravone | Posted | Mean | Standard Deviation | percentage | Urine samples are collected: 0 to 24 hours after oral administration |
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| Primary | Renal Clearance (CLr) of Unchanged Edaravone | Posted | Mean | Standard Deviation | L/h | Urine samples are collected: 0 to 24 hours after oral administration |
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| Secondary | Number of Participants With Adverse Events and Adverse Drug Reactions | Posted | Count of Participants | Participants | Day 1 to 8 |
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| 9 |
| 0 |
| 9 |
| 1 |
| 9 |
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| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |