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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
31
Auckland Clinical Studies Ltd.
Grafton, Auckland, New Zealand
PK parameter: Maximum observed concentration (Cmax) of DNL343 in plasma
Time frame: Up to 15 days
PK parameter: Time to maximum observed concentration (Tmax) of DNL343 in plasma
Time frame: 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
Time frame: Up to 15 days
PK parameter: The area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of DNL343 in plasma
Time frame: Up to 15 days
PK parameter: Maximum observed concentration (Cmax) of DNL343 in plasma in the fed versus fasted states
Time frame: Up to 15 days
PK parameter: Time to maximum observed concentration (Tmax) of DNL343 in plasma in the fed versus fasted states
Time frame: 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 in the fed versus fasted states
Time frame: 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
Time frame: Up to 15 days
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: Up to 15 days
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