In this open label, single-sequence study, subjects received one dose of XS004 Dasatinib Amorphous Solid Dispersion Film-Coated Tablet, 90 mg Test Formulation at the start of study on Day 1 and Day 6. Omeprazole 40 mg was administered on Day 2, 3, 4, 5 and 6. The study was conducted in two groups.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
17
XS004 Dasatinib Amorphous Solid Dispersion Film-Coated Tablet, 90 mg Test Formulation
Omeprazole Delayed Release Capsules, USP 40 mg
AXIS Clinicals
Dilworth, Minnesota, United States
Maximum Observed Plasma Concentration of Dasatinib (Cmax)
Pharmacokinetic parameters (Cmax) for plasma dasatinib on Day 1 (Dasatinib alone) and on Day 6 (Dasatinib + Omeprazole) calculated for each subject using drug concentration-time data by non-compartmental methods.
Time frame: Blood samples collected at 15 time points (including pre-dose) during the study period on Day 1 and Day 6.
Area Under the Plasma Concentration-Time Curve from Zero to 24h
Pharmacokinetic parameters (AUC 0-24) for plasma dasatinib on Day 1 (Dasatinib alone) and on Day 6 (Dasatinib + Omeprazole) calculated for each subject using drug concentration-time data by non-compartmental methods.
Time frame: Blood samples collected at 15 time points (including pre-dose) during the study period on Day 1 and Day 6.
Area Under the Plasma Concentration-Time Curve from Zero Extrapolated to Infinity
Pharmacokinetic parameters (AUC 0-INF) for plasma dasatinib on Day 1 (Dasatinib alone) and on Day 6 (Dasatinib + Omeprazole) calculated for each subject using drug concentration-time data by non-compartmental methods.
Time frame: Blood samples collected at 15 time points (including pre-dose) during the study period on Day 1 and Day 6.
Area Under the Plasma Concentration-Time Curve (Percent Extrapolation)
Pharmacokinetic parameters (AUC %Extrapolation) for plasma dasatinib on Day 1 (Dasatinib alone) and on Day 6 (Dasatinib + Omeprazole) calculated for each subject using drug concentration-time data by non-compartmental methods.
Time frame: Blood samples collected at 15 time points (including pre-dose) during the study period on Day 1 and Day 6.
Time of Maximum Observed Plasma Concentration of Dasatinib (Tmax)
Pharmacokinetic parameters (Tmax) for plasma dasatinib on Day 1 (Dasatinib alone) and on Day 6 (Dasatinib + Omeprazole) calculated for each subject using drug concentration-time data by non-compartmental methods.
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Time frame: Blood samples collected at 15 time points (including pre-dose) during the study period on Day 1 and Day 6.
Elimination Rate Constant (Kel)
Pharmacokinetic parameters (Kel) for plasma dasatinib on Day 1 (Dasatinib alone) and on Day 6 (Dasatinib + Omeprazole) calculated for each subject using drug concentration-time data by non-compartmental methods. Apparent first order elimination rate constant calculated from a semi-log plot of plasma concentration versus time point.
Time frame: Blood samples collected at 15 time points (including pre-dose) during the study period on Day 1 and Day 6.
Terminal Half-Life (T1/2)
Pharmacokinetic parameters (T1/2) for plasma dasatinib on Day 1 (Dasatinib alone) and on Day 6 (Dasatinib + Omeprazole) calculated for each subject using drug concentration-time data by non-compartmental methods.
Time frame: Blood samples collected at 15 time points (including pre-dose) during the study period on Day 1 and Day 6.