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This is a Phase 1 relative bioavailability study carried out in approximately 24 healthy male subjects and healthy female subjects of non childbearing potential to investigate the effects of formulation and food on the safety, tolerability, and pharmacokinetics (PK) of DNL343.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Experimental |
| |
| Cohort B | Experimental |
| |
| Cohort C | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DNL343 | Drug | Multiple oral doses |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameter: Maximum observed concentration (Cmax) of DNL343 in plasma | Up to 15 days | |
| PK parameter: Time to maximum observed concentration (Tmax) of DNL343 in plasma | Up to 15 days | |
| PK Parameter: Area under the concentration-time curve from time zero to the last quantifiable time point (AUC0-t) of DNL343 in plasma | Up to 15 days | |
| PK parameter: The area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of DNL343 in plasma | Up to 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameter: Maximum observed concentration (Cmax) of DNL343 in plasma in the fed versus fasted states | Up to 15 days | |
| PK parameter: Time to maximum observed concentration (Tmax) of DNL343 in plasma in the fed versus fasted states | Up to 15 days |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Tsai, MD | Denali Therapeutics Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Auckland Clinical Studies Ltd. | Grafton | Auckland | New Zealand |
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| Drug |
Single oral dose |
|
| DNL343 | Drug | Single oral dose |
|
| PK Parameter: Area under the concentration-time curve from time zero to the last quantifiable time point (AUC0-t) of DNL343 in plasma in the fed versus fasted states | Up to 15 days |
| PK parameter: The area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of DNL343 in plasma in the fed versus fasted states | Up to 15 days |
| Incidence of treatment-emergent adverse events (TEAEs) | Up to 15 days |