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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-000252-11 | EudraCT Number | ||
| MUT21622-21622X | Other Identifier | Cinical Research Organisation |
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| Name | Class |
|---|---|
| ICON plc | INDUSTRY |
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MT1980 is being developed as a treatment for neuroinflammation (an inflammatory response in the brain and/or spinal cord). Much research has focused on the central role of neuroinflammation in the pathogenesis of many conditions relating to the CNS, including eg, traumatic brain injury, stroke, Alzheimer's disease, post-operative cognitive decline (POCD)/perioperative neurocognitive disorder, and now even long-term cognitive side effects from severe acute respiratory syndrome corona virus 2 (SARS-CoV-2). Current anti-inflammatories do not easily cross the blood-brain barrier from the systemic circulation to the brain, making neuroinflammation a difficult condition to treat.
This will be a Phase 1, single dose, randomized, placebo-controlled study in healthy subjects. The study will provide information on the safety of MT1980, the systemic bioavailability of the active drug, and levels of the active drug in the CSF. The study will be conducted in two parts. In Part 1, subjects will be randomized to receive a single oral dose of MT1980 or placebo in a parallel design. An interim PK and safety data analysis will be performed after Part 1 prior to dose selection in Part 2. In Part 2 subjects will be randomized to receive either placebo or a single oral dose of MT1980 at one of 2 strengths in a parallel design.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 MT1980 | Experimental |
| |
| Part 1 Placebo | Placebo Comparator |
| |
| Part 2 MT1980 Dose Level 1 | Experimental |
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| Part 2 MT1980 Dose Level 2 | Experimental |
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| Part 2 Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MT1980 | Drug | single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-related adverse events | Descriptive statistics comparing MT1980 & placebo following a single dose of study drug. Number of subjects, number of events and severity of events to be reported | Day 1 to Day 11 |
| Measure | Description | Time Frame |
|---|---|---|
| Systemic bioavailability of MT1980 | 72 hours post dose | |
| Level of MT1980 in CSF | up to 7 hours post dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Principal Investigator | Icon Early Development Services | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icon Early Development Services | Groningen | Netherlands |
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| ID | Term |
|---|---|
| D000090862 | Neuroinflammatory Diseases |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Part 1: Open Label Part 2: Blinded
| Placebo | Drug | single dose |
|