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OpenTrials
Completed

NCT Number: NCT05433896

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

AXIS Clinicals

Dilworth, Minnesota, 56529-1342, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dasatinib ASD

Drug

XS004 Dasatinib Amorphous Solid Dispersion Film-Coated Tablet, 90 mg Test Formulation

Omeprazole 40 MG

Drug

Omeprazole Delayed Release Capsules, USP 40 mg

Primary outcomes

  1. Maximum Observed Plasma Concentration of Dasatinib (Cmax)

    Time frame: 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.

  2. Area Under the Plasma Concentration-Time Curve from Zero to 24h

    Time frame: 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.

  3. Area Under the Plasma Concentration-Time Curve from Zero Extrapolated to Infinity

    Time frame: 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 outcomes

  1. Area Under the Plasma Concentration-Time Curve (Percent Extrapolation)

    Time frame: 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.

  2. Time of Maximum Observed Plasma Concentration of Dasatinib (Tmax)

    Time frame: 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.

  3. Elimination Rate Constant (Kel)

    Time frame: 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.

  4. Terminal Half-Life (T1/2)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Xspray Pharma AB

Industry

Collaborators

  • Axis Clinicals Limited

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 27, 2022
Registry last updated
Jun 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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