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To assess the pharmacokinetics of MCI-186 after a single intravenous infusion of 30mg/hour in subjects with mild or moderate Hepatic impairment compared to subjects with normal hepatic function
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mild hepatic impairment | Experimental |
| |
| moderate hepatic impairment | Experimental |
| |
| normal hepatic function | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MCI-186 | Drug | 30 mg of edaravone will be administered intravenously over 60 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dose | |
| AUC0-last | pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dose | |
| AUC0-∞ | pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| t½ | pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dose |
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Inclusion Criteria:
All subjects
Hepatic impaired subjects (in addition)
Healthy subjects (in addition)
Exclusion Criteria:
All subjects
Hepatic impairment subject (in addition)
Healthy subject (in addition)
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| Name | Affiliation | Role |
|---|---|---|
| General Manager | Tanabe Pharma Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational site | Fukuoka | Japan | ||||
| Investigational site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32800532 | Derived | Nakamaru Y, Kakubari M, Yoshida K, Akimoto M, Todorovic V, Greis T, Kondo K. Open-label, Single-dose Studies of the Pharmacokinetics of Edaravone in Subjects with Mild, Moderate, or Severe Hepatic Impairment Compared to Subjects with Normal Hepatic Functioning. Clin Ther. 2020 Aug;42(8):1467-1482.e4. doi: 10.1016/j.clinthera.2020.06.016. Epub 2020 Aug 14. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mild Hepatic Impairment | Child-Pugh score of 5 or 6 |
| FG001 | Moderate Hepatic Impairment | Child-Pugh score between 7 and 9 |
| FG002 | Normal Hepatic Function | normal hepatic function |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mild Hepatic Impairment | Child-Pugh score of 5 or 6 |
| BG001 | Moderate Hepatic Impairment | Child-Pugh score between 7 and 9 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Cmax | PK population | Posted | Mean | Standard Deviation | ng/mL | pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dose |
|
7 days
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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 | Mild Hepatic Impairment | Child-Pugh score of 5 or 6 | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest pain | General disorders | MedDRA 20.0 | 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 | Apr 2, 2018 | Nov 26, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 9, 2018 | Nov 26, 2019 | 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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|
| Tokyo |
| Japan |
| BG002 | Normal Hepatic Function | normal hepatic function |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | AUC0-last | PK population | Posted | Mean | Standard Deviation | ng*hr/mL | pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dose |
|
|
|
| Primary | AUC0-∞ | PK population | Posted | Mean | Standard Deviation | ng*hr/mL | pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dose |
|
|
|
| Secondary | t½ | PK population | Posted | Mean | Standard Deviation | hour | pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dose |
|
|
|
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Moderate Hepatic Impairment | Child-Pugh score between 7 and 9 | 0 | 6 | 0 | 6 | 1 | 6 |
| EG002 | Normal Hepatic Function | normal hepatic function | 0 | 8 | 0 | 8 | 0 | 8 |
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| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |