This study is a phase 1, open-label, randomized, four-period crossover study to evaluate the effect of food and rabeprazole on the ZN-A-1041 tablet formulation in healthy male and female participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
24
Participants will receive a single dose of ZN-A-1041 Formulation 1 on each specified treatment.
Participants will receive a single dose of ZN-A-1041 Formulation 2 on each specified treatment.
Participants will receive an oral administration of rabeprazole twice daily (BID) on days 9, 10, 15, and 16 and a single dose on Days 11 and 17.
Daytona Beach Clinical Rsch Unit
Daytona Beach, Florida, United States
Fortrea Clinical Research Unit - Dallas
Dallas, Texas, United States
Maximum Observed Concentration (Cmax)
Time frame: Days 1 to 8, 11 to 14, and 17 to 20
Area Under the Concentration-time Curve (AUC) From Hour 0 to the Last Measurable Concentration (AUC0-t)
Time frame: Days 1 to 8, 11 to 14, and 17 to 20
AUC Extrapolated to Infinity (AUC0-∞)
Time frame: Days 1 to 8, 11 to 14, and 17 to 20
Geometric Mean Ratio and Associated 90% Confidence Interval (CI) of Cmax, AUC0-t, and AUC0-∞
Time frame: Days 1 to 8, 11 to 14, and 17 to 20
ZN-A-1041 PK Parameters Time to Maximum Observed Concentration (Tmax) for All Treatments
Time frame: Days 1 to 8, 11 to 14, and 17 to 20
ZN-A-1041 Apparent Terminal Elimination Rate Constant (λz) for All Treatments
Time frame: Days 1 to 8, 11 to 14, and 17 to 20
ZN-A-1041 Apparent Terminal Elimination Half-life (t1/2) for All Treatments
Time frame: Days 1 to 8, 11 to 14, and 17 to 20
ZN-A-1041 Apparent Systemic Clearance (CL/F) for All Treatments
Time frame: Days 1 to 8, 11 to 14, and 17 to 20
ZN-A-1041 Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F) for All Treatments
Time frame: Days 1 to 8, 11 to 14, and 17 to 20
Incidence of Adverse Events (AEs), Including Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs)
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Time frame: Up to approximately 8.5 weeks
Severity of AEs, Including SAEs and AESIs
Time frame: Up to approximately 8.5 weeks
Number of Participants with Abnormalities in Clinical Laboratory Results
Time frame: Baseline, Days 2, 4, 6, 10, 16, and 20
Changes from Baseline in Oral Temperature Measurements
Time frame: Baseline, Days 1, 2, 5, 6, 11, 12, 17, 18, and 20
Columbia Suicide Severity Rating Scale (C-SSRS) Questionnaires
Time frame: Baseline, Day 1, 5, 11, 17, and 20
Changes from Baseline in Respiratory Rate Measurements
Time frame: Baseline, Days 1, 2, 5, 6, 11, 12, 17, 18, and 20
Changes from Baseline in Systolic Blood Pressure Measurements
Time frame: Baseline, Days 1, 2, 5, 6, 11, 12, 17, 18, and 20
Changes from Baseline in Pulse Rate Measurements
Time frame: Baseline, Days 1, 2, 5, 6, 11, 12, 17, 18, and 20
Changes from Baseline in Diastolic Blood Pressure Measurements
Time frame: Baseline, Days 1, 2, 5, 6, 11, 12, 17, 18, and 20
Changes from Baseline in 12-lead Electrocardiogram (ECG) Parameters (RR, PR, QRS, and QT Duration)
Time frame: Baseline, Days 1, 2, 5, 6, 11, 12, 17, 18, and 20
Changes from Baseline in 12-lead ECG Parameters (Heart Rate)
Time frame: Baseline, Days 1, 2, 5, 6, 11, 12, 17, 18, and 20
Changes from Baseline in 12-lead ECG Parameters (Sinus Rhythm)
Time frame: Baseline, Days 1, 2, 5, 6, 11, 12, 17, 18, and 20
Changes from Baseline in 12-lead ECG Parameters (QTcF)
Time frame: Baseline, Days 1, 2, 5, 6, 11, 12, 17, 18, and 20