Healthy Volunteers
Conditions
Brief summary
This is a Phase 1, open-label, nonrandomized, single-dose study in healthy male participants to investigate the absorption, metabolism and excretion of DNL343.
Interventions
DRUG[14C]-DNL343
Single dose
Sponsors
Denali Therapeutics Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
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 minimum of 1 bowel movement per day
Exclusion criteria
* History or clinical manifestation of any clinically significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder * Have a history of malignancy, except fully resected basal cell carcinoma * History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance * History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs * Have previously completed or withdrawn from this study or any other study investigating DNL343 and have previously received DNL343
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Extent and rate of recovery of total radioactivity in urine and feces | 28 days | — |
| PK Parameter: AUC0-∞ | 28 days | The area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of DNL343 in plasma |
| PK Parameter: AUC0-tlast | 28 days | Area under the concentration-time curve from time zero to the last quantifiable time point (AUC0-tlast) of DNL343 in plasma |
| PK Parameter: Cmax | 28 days | Maximum observed concentration (Cmax) of DNL343 in plasma |
| PK Parameter: Tmax | 28 days | Time to maximum observed concentration (Tmax) of DNL343 in plasma |
| PK Parameter: t1/2 | 28 days | Terminal elimination half-life (t1/2) of DNL343 in plasma |
| Total radioactivity in plasma and whole blood | 28 days | — |
| Total radioactivity in blood-to-plasma ratio | 28 days | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PK Parameter: AUC0-tlast | 28 days | Area under the concentration-time curve from time zero to the last quantifiable time point (AUC0-tlast) of a DNL343 metabolite in plasma |
| PK Parameter: Cmax | 28 days | Maximum observed concentration (Cmax) of a DNL343 metabolite in plasma |
| PK Parameter: Tmax | 28 days | Time to maximum observed concentration (Tmax) of a DNL343 metabolite in plasma |
| PK Parameter: t1/2 | 28 days | Terminal elimination half-life (t1/2) of a DNL343 metabolite in plasma |
| DNL343 and a DNL343 metabolite recoveries in urine | 28 days | — |
| Incidence, severity, and seriousness of treatment-emergent adverse events (TEAEs) | 28 days | — |
| PK Parameter: AUC0-∞ | 28 days | The area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of a DNL343 metabolite in plasma |
Countries
United States
Outcome results
None listed