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The purpose of this study is to explore the cardiac pharmacodynamics, safety and tolerability of MT-1303 in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MT-1303-Low | Experimental | MT-1303-Low dose |
|
| MT-1303-High | Experimental | MT-1303-High dose |
|
| Fingolimod | Active Comparator | Fingolimod |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MT-1303-Low | Drug |
| ||
| MT-1303-High |
| Measure | Description | Time Frame |
|---|---|---|
| Mean hourly heart rate | up to day 42 |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentration of MT-1303 and its metabolite | up to day 28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Sowood, M.D | Mitsubishi Tanabe Pharma Europe Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational site | Leeds | United Kingdom |
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| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000068876 | Fingolimod Hydrochloride |
| ID | Term |
|---|---|
| D013110 | Sphingosine |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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|
| Fingolimod | Drug |
|
| Placebo | Drug |
|
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D011409 |
| Propylene Glycols |
| D006018 | Glycols |
| D000588 | Amines |