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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 renal impairment compared to subjects with normal renal function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mild renal impairment | Experimental |
| |
| moderated renal impairment | Experimental |
| |
| normal renal 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
Renal impaired subjects (in addition)
Healthy subjects (in addition)
Exclusion Criteria:
All subjects
Renal 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 | Tokyo | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32868037 | Derived | Nakamaru Y, Kakubari M, Yoshida K, Akimoto M, Kondo K. An Open-label, Single-dose Study to Evaluate the Pharmacokinetic Variables of Edaravone in Subjects with Mild, Moderate, or No Renal Impairment. Clin Ther. 2020 Sep;42(9):1699-1714. doi: 10.1016/j.clinthera.2020.06.020. Epub 2020 Aug 28. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mild Renal Function Group | Mild renal function defined as eGFR 60-89 mL/min/1.73m^2 |
| FG001 | Moderate Renal Function Group | Moderate renal function defined as eGFR 30-59 mL/min/1.73m^2 |
| FG002 | Normal Renal Function Group | Normal renal function defined as eGFR ≥90 mL/min/1.73m^2 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mild Renal Function Group | Mild renal function defined as eGFR 60-89 mL/min/1.73m^2 |
| BG001 | Moderate Renal Function Group | Moderate renal function defined as eGFR 30-59 mL/min/1.73m^2 |
| 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 Renal Function Group | Mild renal function defined as eGFR 60-89 mL/min/1.73m^2 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA/J version20.0 | 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 | Jun 20, 2018 | Nov 26, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D000077553 | Edaravone |
| ID | Term |
|---|---|
| D000983 | Antipyrine |
| D047069 | Pyrazolones |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 |
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|
| BG002 | Normal Renal Function Group | Normal renal function defined as eGFR ≥90 mL/min/1.73m^2 |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | 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 |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 5 |
| 11 |
| EG001 | Moderate Renal Function Group | Moderate renal function defined as eGFR 30-59 mL/min/1.73m^2 | 0 | 8 | 0 | 8 | 0 | 8 |
| EG002 | Normal Renal Function Group | Normal renal function defined as eGFR ≥90 mL/min/1.73m^2 | 0 | 11 | 0 | 11 | 1 | 11 |
| Headache | Nervous system disorders | MedDRA/J version20.0 | Systematic Assessment |
|
| Vomitting | Gastrointestinal disorders | MedDRA/J version20.0 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA/J version20.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA/J version20.0 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA/J version20.0 | Systematic Assessment |
|
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |