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To evaluate the pharmacokinetics of single doses of edaravone oral suspension in Amyotrophic Lateral Sclerosis Patients with gastrostomy
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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, 0.25, 0.5, 1, 2, 4 and 8 hours; Day 2 at 24 hours after administration. | |
| Maximum Plasma Concentration (Cmax) of Unchanged Edaravone | Plasma samples are collected: Day 1 at pre-dose, 0.25, 0.5, 1, 2, 4 and 8 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, 0.25, 0.5, 1, 2, 4 and 8 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, 0.25, 0.5, 1, 2, 4 and 8 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, 0.25, 0.5, 1, 2, 4 and 8 hours; Day 2 at 24 hours after administration. | |
| Mean Residence Time (MRT) of Unchanged Edaravone | Plasma samples are collected: Day 1 at pre-dose, 0.25, 0.5, 1, 2, 4 and 8 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, 0.25, 0.5, 1, 2, 4 and 8 hours; Day 2 at 24 hours after administration. | |
| Apparent Distribution Volume at Elimination Phase (Vz/F) of Unchanged Edaravone |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events and Adverse Drug Reactions | The provision of informed consent to Day 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 | Chiba | 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 via a percutaneous endoscopic gastrostomy (PEG) tube. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | MT-1186 | ALS patients receive the edaravone oral suspension via a percutaneous endoscopic gastrostomy (PEG) tube. |
| Units | Counts |
|---|---|
| Participants |
|
| 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, 0.25, 0.5, 1, 2, 4 and 8 hours; Day 2 at 24 hours after administration. |
|
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The provision of informed consent 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 via a percutaneous endoscopic gastrostomy (PEG) tube. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Folliculitis | Infections and infestations | MedDRA 22.1 | 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 | Nov 1, 2019 | Apr 18, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 11, 2020 | 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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| Plasma samples are collected: Day 1 at pre-dose, 0.25, 0.5, 1, 2, 4 and 8 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, 0.25, 0.5, 1, 2, 4 and 8 hours; Day 2 at 24 hours after administration |
| Cumulative Amount of Drug Excreted in Urine (Ae) of Edaravone | This information will not be disclosed because it may identify the patient (N=1). | Urine samples are collected: 0 to 8 hours after oral administration |
| Cumulative Percentage of Drug Excreted in Urine (Ae) of Edaravone | This information will not be disclosed because it may identify the patient (N=1) | Urine samples are collected: 0 to 8 hours after oral administration |
| Renal Clearance (CLr) of Edaravone | This information will not be disclosed because it may identify the patient (N=1). | Urine samples are collected: 0 to 8 hours after oral administration |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
| Primary | Maximum Plasma Concentration (Cmax) of Unchanged Edaravone | Posted | Mean | Standard Deviation | ng/mL | Plasma samples are collected: Day 1 at pre-dose, 0.25, 0.5, 1, 2, 4 and 8 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, 0.25, 0.5, 1, 2, 4 and 8 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, 0.25, 0.5, 1, 2, 4 and 8 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, 0.25, 0.5, 1, 2, 4 and 8 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, 0.25, 0.5, 1, 2, 4 and 8 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, 0.25, 0.5, 1, 2, 4 and 8 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, 0.25, 0.5, 1, 2, 4 and 8 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, 0.25, 0.5, 1, 2, 4 and 8 hours; Day 2 at 24 hours after administration |
|
|
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| Primary | Cumulative Amount of Drug Excreted in Urine (Ae) of Edaravone | This information will not be disclosed because it may identify the patient (N=1). | Posted | Mean | Standard Deviation | mg | Urine samples are collected: 0 to 8 hours after oral administration |
|
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| Primary | Cumulative Percentage of Drug Excreted in Urine (Ae) of Edaravone | This information will not be disclosed because it may identify the patient (N=1) | Posted | Mean | Standard Deviation | percentage of dose | Urine samples are collected: 0 to 8 hours after oral administration |
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| Primary | Renal Clearance (CLr) of Edaravone | This information will not be disclosed because it may identify the patient (N=1). | Posted | Mean | Standard Deviation | L/h | Urine samples are collected: 0 to 8 hours after oral administration |
|
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| Secondary | Number of Participants With Adverse Events and Adverse Drug Reactions | Posted | Count of Participants | Participants | The provision of informed consent to Day 8 |
|
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| 0 |
| 6 |
| 2 |
| 6 |
| 3 |
| 6 |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
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| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
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| Anal eczema | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
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| Stoma site hypergranulation | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
|
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| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |