Evaluating the Effects of Omeprazole on the Pharmacokinetics of XS004 (Dasatinib) Tablets in Healthy Adult Subjects Under Fasting Conditions

Pharmacokinetics Clinical Trial

Official title:

An Open Label, Non-Randomized, Two-Treatment, Single-Period, Single-Dose, Drug-Drug Interaction Study to Evaluate the Effects of Omeprazole on the Pharmacokinetics of XS004 (Dasatinib) 90 mg Film-Coated Tablets in Healthy Adult Subjects Under Fasting Conditions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05433896
• Other study ID #: XS004-09
• Status: Completed
• Phase: Phase 1
• Start date: November 1, 2020
• Est. completion date: December 19, 2020

Study information

• Verified date: June 2022
• Source: Xspray Pharma AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: December 19, 2020
• Est. primary completion date: December 19, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Drug Interactions
• Pharmacokinetics

Intervention

Drug:
• Dasatinib ASD
XS004 Dasatinib Amorphous Solid Dispersion Film-Coated Tablet, 90 mg Test Formulation
• Omeprazole 40 MG
Omeprazole Delayed Release Capsules, USP 40 mg

Locations

Country	Name	City	State
United States	AXIS Clinicals	Dilworth	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Xspray Pharma AB	Axis Clinicals Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Blood samples collected at 15 time points (including pre-dose) during the study period on Day 1 and Day 6.
Primary	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.	Blood samples collected at 15 time points (including pre-dose) during the study period on Day 1 and Day 6.
Primary	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.	Blood samples collected at 15 time points (including pre-dose) during the study period on Day 1 and Day 6.
Secondary	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.	Blood samples collected at 15 time points (including pre-dose) during the study period on Day 1 and Day 6.
Secondary	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.	Blood samples collected at 15 time points (including pre-dose) during the study period on Day 1 and Day 6.
Secondary	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.	Blood samples collected at 15 time points (including pre-dose) during the study period on Day 1 and Day 6.
Secondary	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.	Blood samples collected at 15 time points (including pre-dose) during the study period on Day 1 and Day 6.