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This is a Phase 1, open-label, nonrandomized, single-dose study in healthy male participants to investigate the absorption, metabolism and excretion of DNL343.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 14C-DNL343 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]-DNL343 | Drug | Single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| PK Parameter: AUC0-∞ | The area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of DNL343 in plasma | 28 days |
| PK Parameter: AUC0-tlast | Area under the concentration-time curve from time zero to the last quantifiable time point (AUC0-tlast) of DNL343 in plasma | 28 days |
| PK Parameter: Cmax | Maximum observed concentration (Cmax) of DNL343 in plasma | 28 days |
| PK Parameter: Tmax | Time to maximum observed concentration (Tmax) of DNL343 in plasma | 28 days |
| PK Parameter: t1/2 | Terminal elimination half-life (t1/2) of DNL343 in plasma | 28 days |
| Total radioactivity in plasma and whole blood | 28 days | |
| Total radioactivity in blood-to-plasma ratio | 28 days | |
| Extent and rate of recovery of total radioactivity in urine and feces | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| PK Parameter: AUC0-∞ | The area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of a DNL343 metabolite in plasma | 28 days |
| PK Parameter: AUC0-tlast | Area under the concentration-time curve from time zero to the last quantifiable time point (AUC0-tlast) of a DNL343 metabolite in plasma |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ana-Claire Meyer, MD | Denali Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Site | Madison | Wisconsin | 53704 | United States |
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| 28 days |
| PK Parameter: Cmax | Maximum observed concentration (Cmax) of a DNL343 metabolite in plasma | 28 days |
| PK Parameter: Tmax | Time to maximum observed concentration (Tmax) of a DNL343 metabolite in plasma | 28 days |
| PK Parameter: t1/2 | Terminal elimination half-life (t1/2) of a DNL343 metabolite in plasma | 28 days |
| DNL343 and a DNL343 metabolite recoveries in urine | 28 days |
| Incidence, severity, and seriousness of treatment-emergent adverse events (TEAEs) | 28 days |