Pharmacokinetics, Drug Interactions
Conditions
Brief summary
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.
Interventions
DRUGDasatinib ASD
XS004 Dasatinib Amorphous Solid Dispersion Film-Coated Tablet, 90 mg Test Formulation
DRUGOmeprazole 40 MG
Omeprazole Delayed Release Capsules, USP 40 mg
Sponsors
Axis Clinicals Limited
Xspray Pharma AB
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Age: 18-60 years * Sex: Healthy adult males (sterile or using contraception) and females of non-childbearing potential * Clinical laboratory values should be within the laboratory's stated normal range. If not within this range, they must be without clinical significance, as determined by the Investigator * No clinically significant diseases captured in the medical history or evidence of clinically significant findings on the physical examination (including vital signs) and/or ECG, as determined by the Investigator * Any abnormalities/deviations from the acceptable range of medical history, laboratory values, ECG, and vital signs that might be considered clinically relevant by the study physician or Investigator will be evaluated as individual cases * Able to comply with study procedures, in the opinion of the Investigator(s) * Willing to give written consent, pregnancy outcome consent, and adhere to all the requirements of this protocol
Exclusion criteria
* Any major illness in the last three months or any significant ongoing chronic medical illness * Does not agree to consume the provided meals * Participation in any clinical trial 30 days prior to dosing * Positive results for drugs of abuse or alcohol breath analysis prior to dosing * Positive screening results to HIV Ag/Ab Combo, Hepatitis B surface Antigen, Hepatitis C Virus, or anti-HBc tests * Females currently breastfeeding, demonstrating a positive pregnancy screen, or using hormone replacement therapy within three months prior to dosing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Observed Plasma Concentration of Dasatinib (Cmax) | Blood samples collected at 15 time points (including pre-dose) during the study period on Day 1 and Day 6. | 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. |
| Area Under the Plasma Concentration-Time Curve from Zero to 24h | Blood samples collected at 15 time points (including pre-dose) during the study period on Day 1 and Day 6. | 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. |
| Area Under the Plasma Concentration-Time Curve from Zero Extrapolated to Infinity | Blood samples collected at 15 time points (including pre-dose) during the study period on Day 1 and Day 6. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Plasma Concentration-Time Curve (Percent Extrapolation) | Blood samples collected at 15 time points (including pre-dose) during the study period on Day 1 and Day 6. | 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. |
| Terminal Half-Life (T1/2) | Blood samples collected at 15 time points (including pre-dose) during the study period on Day 1 and Day 6. | 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 of Maximum Observed Plasma Concentration of Dasatinib (Tmax) | Blood samples collected at 15 time points (including pre-dose) during the study period on Day 1 and Day 6. | 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. |
| Elimination Rate Constant (Kel) | Blood samples collected at 15 time points (including pre-dose) during the study period on Day 1 and Day 6. | 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. |
Countries
United States
Outcome results
None listed