This is a single-center, randomized, open-label, two-period, 2-way crossover food effect study to determine the comparative bioavailability of ZN-c5 under fed and fasting conditions, following single-dose administration of ZN-c5 capsules (150mg).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
20
ZN-c5 is the study drug.
Site 1
Christchurch, New Zealand
AUC0-t
Area under the plasma concentration-time curve (AUC) from time zero to the last sampling time
Time frame: Days 1-4
Cmax
Maximum concentration
Time frame: Days 1-4
Tmax
Time to maximum concentration
Time frame: Days 1-4
AUC0-infinity
Area under the plasma concentration-time curve (AUC) from time zero to infinity
Time frame: Days 1-4
Assess the incidence, frequency, and severity of treatment-emergent adverse events (TEAEs)
Safety and tolerability of ZN-c5
Time frame: Approximately 45 days
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