This is a Phase 1, open-label, randomized, two-part study to evaluate the relative bioavailability (rBA) of two tablet formulations compared to the capsule formulation of ZN-A-1041 (Part 1). Part 2 of the study will evaluate the effect of food and rabeprazole on the ZN-A-1041 tablet formulation. No participants were enrolled in Part 2 of the study as it has been cancelled.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
18
Participants will be administered either a ZN-A-1041 capsule or a tablet orally.
Fortrea Leeds CRU
Leeds, United Kingdom
Maximum Observed Concentration (Cmax)
Time frame: Days 1-12 (Part 1)
Area Under the Concentration-Time curve from Hour 0 to the Last Measurable Concentration (AUC0-t)
Time frame: Days 1-12 (Part 1)
AUC Extrapolated to Infinity (AUC0-inf)
Time frame: Days 1-12 (Part 1)
Geometric Mean Ratio and Associated 90% Confidence Interval (CI) of Cmax
Time frame: Days 1-12 (Part 1)
Geometric Mean Ratio and Associated 90% CI of AUC0-t
Time frame: Days 1-12 (Part 1)
Geometric Mean Ratio and Associated 90% CI of AUC0-inf
Time frame: Days 1-12 (Part 1)
Time to Maximum Observed Concentration (tmax)
Time frame: Days 1-12 (Part 1)
Apparent Terminal Elimination Rate Constant
Time frame: Days 1-12 (Part 1)
Apparent Terminal Elimination Half-Life (t1/2)
Time frame: Days 1-12 (Part 1)
Apparent Systemic Clearance (CL/F)
Time frame: Days 1-12 (Part 1)
Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F)
Time frame: Days 1-12 (Part 1)
Percentage of Participants With Adverse Events (AEs)
Time frame: Up to approximately 16 days
Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Baseline, days 1, 5, 9 and 12 (Part 1)
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