Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06281158 | A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-DNL343 Following a Single Oral Dose in Healthy Male Participants | PHASE1 | COMPLETED | 7 | — | — | Mar 1, 2024 | Apr 30, 2024 | Jun 20, 2024 | 1 | United States |
| NCT04581772 | A Study to Evaluate the Bioavailability and Safety of DNL343 in Healthy Volunteers | PHASE1 | COMPLETED | 31 | — | — | Dec 23, 2020 | Jun 4, 2021 | Jun 11, 2021 | 1 | New Zealand |
| NCT04268784 | A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL343 in Healthy Volunteers | PHASE1 | COMPLETED | 96 | — | — | Feb 20, 2020 | Aug 3, 2021 | Feb 7, 2022 | 1 | Netherlands |
The area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of DNL343 in plasma
Area under the concentration-time curve from time zero to the last quantifiable time point (AUC0-tlast) of DNL343 in plasma
Maximum observed concentration (Cmax) of DNL343 in plasma
Time to maximum observed concentration (Tmax) of DNL343 in plasma
Terminal elimination half-life (t1/2) of DNL343 in plasma
| Arm | Type | Description |
|---|---|---|
| 14C-DNL343 | EXPERIMENTAL | - |
| Cohort A | EXPERIMENTAL | - |
| Cohort B | EXPERIMENTAL | - |
| Cohort C | EXPERIMENTAL | - |
| DNL343 | EXPERIMENTAL | Cohort A: Single-ascending dose; Cohort B: Multiple-ascending doses |
| Placebo | PLACEBO_COMPARATOR | Cohort A: Single-ascending dose; Cohort B: Multiple-ascending doses |
| Name | Type | Description |
|---|---|---|
| [14C]-DNL343 | DRUG | Single dose |
| DNL343 | DRUG | Multiple oral doses |
| Placebo | DRUG | Single oral dose |
Inclusion Criteria: * Males, aged between 18 to 65 years, inclusive * Body mass index between 18.0 and 32.0 kg/m2 * In good health * When engaging in sex with a woman of child bearing potential, both the male participant and his female partner must use highly effective contraception * History of a ...