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| Name | Class |
|---|---|
| Biogen | INDUSTRY |
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This is a single and multiple dose, open-label study to evaluate the pharmacokinetics (PK), safety, and tolerability of dexpramipexole administered orally to adult Japanese and Caucasian healthy subjects.
The study is designed to evaluate the influence of ethnic factors on dexpramipexole safety, tolerability, and PK. Subjects will be admitted to the clinical unit on Day -1 (the day prior to first dosing) and will remain in the clinical unit under observation until discharge. All subjects will have a final follow up visit. Whilst resident in the clinic, subjects will receive 4 treatments: The first 3 treatments comprise Part A of the study and the final treatment group comprises Part B.
Part A:
Treatment 1: Dose 1 (reduced) of dexpramipexole; a single dose Treatment 2: Dose 2 (standard) dexpramipexole; a single dose Treatment 3: Dose 3 (standard) dexpramipexole; 5 doses administered at 12 hour intervals Part B: Dose 4 (standard) dexpramipexole; 5 doses administered at 12 hour intervals There will be a minimum washout of 3 days between treatments.
For all subjects, prior to proceeding to the next treatment group, safety and tolerability data will be reviewed.
Caucasian subjects will be matched individually (on a 1:1 basis) to Japanese subjects with respect to gender and age and if possible BMI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment 1 (Part A) | Experimental | Dexpramipexole single dose (reduced dose) |
|
| Treatment 2 (Part A) | Experimental | Dexpramipexole single dose (Standard dose) |
|
| Treatment 3 (Part A) | Experimental | Dexpramipexole multiple dosing |
|
| Treatment for Part B | Experimental | Dexpramipexole multiple dosing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single dose reduced | Drug | Treatment 1 (Part A) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of dexpramipexole | pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours after dosing on Days 1 and 5 in Treatments 1 and 2, and after the fifth dose on Day 11 in Treatment 3 for Parts A & B. | |
| AUC of dexpramipexole | pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours after dosing on Days 1 and 5 in Treatments 1 and 2, and after the fifth dose on Day 11 in Treatment 3 for Parts A & B. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in clinical laboratory tests | pre-dose to 72 hrs post-dose in each dose group and again at follow-up (14 hrs post last dose) | |
| ECG changes | pre-dose to 72 hrs post-dose in each dose group and again at follow-up (14 hrs post last dose) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | London | United Kingdom |
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| ID | Term |
|---|---|
| D000690 | Amyotrophic Lateral Sclerosis |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016472 | Motor Neuron Disease |
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| Single dose standard |
| Drug |
Treatment 2 (Part A) |
|
| Multiple Dose | Drug | Treatment 3 (Part A) |
|
| Multiple Dose | Drug | Part B |
|
| Vital Sign changes | pre-dose to 72 hrs post-dose in each dose group and again at follow-up (14 hrs post last dose) |
| Adverse Event monitoring | pre-dose to 72 hrs post-dose in each dose group and again at follow-up (14 hrs post last dose) |
| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |