This is a Phase 1, open-label, nonrandomized, single-dose study in healthy male participants to investigate the absorption, metabolism and excretion of DNL343.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
Single dose
Clinical Site
Madison, Wisconsin, United States
PK Parameter: AUC0-∞
The area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of DNL343 in plasma
Time frame: 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
Time frame: 28 days
PK Parameter: Cmax
Maximum observed concentration (Cmax) of DNL343 in plasma
Time frame: 28 days
PK Parameter: Tmax
Time to maximum observed concentration (Tmax) of DNL343 in plasma
Time frame: 28 days
PK Parameter: t1/2
Terminal elimination half-life (t1/2) of DNL343 in plasma
Time frame: 28 days
Total radioactivity in plasma and whole blood
Time frame: 28 days
Total radioactivity in blood-to-plasma ratio
Time frame: 28 days
Extent and rate of recovery of total radioactivity in urine and feces
Time frame: 28 days
PK Parameter: AUC0-∞
The area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of a DNL343 metabolite in plasma
Time frame: 28 days
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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
Time frame: 28 days
PK Parameter: Cmax
Maximum observed concentration (Cmax) of a DNL343 metabolite in plasma
Time frame: 28 days
PK Parameter: Tmax
Time to maximum observed concentration (Tmax) of a DNL343 metabolite in plasma
Time frame: 28 days
PK Parameter: t1/2
Terminal elimination half-life (t1/2) of a DNL343 metabolite in plasma
Time frame: 28 days
DNL343 and a DNL343 metabolite recoveries in urine
Time frame: 28 days
Incidence, severity, and seriousness of treatment-emergent adverse events (TEAEs)
Time frame: 28 days