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| ID | Type | Description | Link |
|---|---|---|---|
| CY6463 | Other Identifier | Cyclerion Therapeutics |
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Stage 1: To assess the safety and tolerability of single-ascending-dose levels of IW-6463 tablets when administered orally to healthy subjects
Stage 2: To assess the safety and tolerability of multiple-ascending-dose levels of IW-6463 tablets administered orally to healthy subjects
Stage 3: To assess the safety and tolerability of a single dose of IW-6463 when administered to health subjects in fed vs fasted states and explore the effects of food on IW-6463 pharmacokinetics (PK)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IW-6463 | Experimental | IW-6463 tablets administered orally as single ascending doses, multiple ascending daily doses, and single doses with or without food |
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| Placebo | Placebo Comparator | Matching placebo tablets administered orally |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IW-6463 | Drug | IW-6463 Tablet |
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| Measure | Description | Time Frame |
|---|---|---|
| After single ascending doses, number of subjects with treatment-emergent adverse events (TEAEs) in the IW-6463 dose-level cohorts vs the (pooled) placebo group. | Up to 9 days | |
| After multiple ascending doses, number of subjects with TEAEs in the IW-6463 dose-level cohorts vs the (pooled) placebo group. | Up to 32 days | |
| After a single dose, number of subjects with TEAEs in the fed vs fasted dosing period | Up to 28 days | |
| Plasma concentration of IW-6463 after single-dose administration under fed vs fasted conditions | Up to 21 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chad Glasser, PharmD | Cyclerion Therapeutics, Inc | Study Director |
| Geert J Groeneveld, MSc | Centre for Human Drug Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Human Drug Research | Leiden | 2333 CL | Netherlands |
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| Matching Placebo | Drug | Matching Placebo Tablet |
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