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| Name | Class |
|---|---|
| Labcorp Corporation of America Holdings, Inc | INDUSTRY |
| Alturas Analytics, Inc. | INDUSTRY |
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This is a Phase 1, open-label, nonrandomized, single-dose human, absorption, metabolism, and excretion study of [14C]-Fosgonimeton
This is a Phase 1, open-label, nonrandomized, single-dose study, designed to evaluate the absorption, metabolism, and excretion of [14C]-Fosgonimeton. Healthy male subjects will receive a single subcutaneous dose of [14C]-Fosgonimeton.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dosing Group | Experimental | All 8 subjects will receive a single dose of study drug |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]-Fosgonimeton | Drug | Carbon-14 Radiolabeled Fosgonimeton |
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| Measure | Description | Time Frame |
|---|---|---|
| Mass balance of total radioactivity from [14C]-Fosgonimeton | Total radioactivity recovery (fet1-t2) | Samples collected pre-dose. |
| Mass balance of total radioactivity from [14C]-Fosgonimeton | Total radioactivity recovery (fet1-t2) | Samples collected up to 9 days post-dose. |
| Routes/rates of elimination of [14C]-Fosgonimeton | Total radioactivity recovery (fet1-t2) through routes of elimination (urine and feces). | Samples collected pre-dose. |
| Routes/rates of elimination of [14C]-Fosgonimeton | Total radioactivity recovery (fet1-t2) through routes of elimination (urine and feces). | Samples collected up to 9 days post-dose. |
| Maximum observed plasma concentration (Cmax) of ATH-1017/ATH-1001 | Cmax will be determined from plasma samples. | Samples collected pre-dose and at predetermined timepoints within 24 hours post-dose. |
| Time to maximum observed plasma concentration (Tmax) of ATH-1017/ATH-1001 | Tmax will be determined from plasma samples | Samples collected pre-dose and at predetermined timepoints within 24 hours post-dose. |
| Area under the plasma concentration time curve (AUC) for of ATH-1017/ATH-1001 | AUC will be determined from plasma samples. |
| Measure | Description | Time Frame |
|---|---|---|
| Quantitative metabolite profiles in plasma, urine, and feces after [14C]-Fosgonimeton administration | Quantification of ATH-1017 major metabolites in plasma and excreta. | Samples collected pre-dose and at predetermined timepoints up to 9 days post-dose |
| The chemical structure of major metabolites in plasma, urine, and feces after [14C]-Fosgonimeton administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Labcorp Clinical Research Unit | Madison | Wisconsin | 53704 | United States |
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| Samples collected pre-dose and at predetermined timepoints within 24 hours post-dose. |
| Half-life (t1/2) of ATH-1017/ATH-1001 | t1/2 will be determined from plasma samples. | Samples collected pre-dose and at predetermined timepoints within 24 hours post-dose. |
Identification of ATH-1017 major metabolites in plasma (>10% relative total drug-related exposure) and excreta (>10% of excreted dose) |
| Samples collected pre-dose and at predetermined timepoints up to 9 days post-dose |
| Incidence and severity of adverse events (safety and tolerability) of [14C]-Fosgonimeton when administered to healthy subjects | Incidence and severity of adverse events | Samples collected pre-dose and at predetermined timepoints up to 17 days post-dose |