Clinical trial NCT05433896: Evaluating the Effects of Omeprazole on the Pharmacokinetics of XS004 (Dasatinib) Tablets in Healthy Adult Subjects Under Fasting Conditions
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetics
Drug Interactions
Lead sponsor: Xspray Pharma AB
Sponsor class: INDUSTRY
Collaborators: name: Axis Clinicals Limited
First posted: 2022-06-27
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Maximum Observed Plasma Concentration of Dasatinib (Cmax)
timeFrame: Blood samples collected at 15 time points (including pre-dose) during the study period on Day 1 and Day 6.
measure: Area Under the Plasma Concentration-Time Curve from Zero to 24h
timeFrame: Blood samples collected at 15 time points (including pre-dose) during the study period on Day 1 and Day 6.
measure: Area Under the Plasma Concentration-Time Curve from Zero Extrapolated to Infinity
timeFrame: Blood samples collected at 15 time points (including pre-dose) during the study period on Day 1 and Day 6.
Secondary outcomes:
measure: Area Under the Plasma Concentration-Time Curve (Percent Extrapolation)
timeFrame: Blood samples collected at 15 time points (including pre-dose) during the study period on Day 1 and Day 6.
measure: Time of Maximum Observed Plasma Concentration of Dasatinib (Tmax)
timeFrame: Blood samples collected at 15 time points (including pre-dose) during the study period on Day 1 and Day 6.
measure: Elimination Rate Constant (Kel)
timeFrame: Blood samples collected at 15 time points (including pre-dose) during the study period on Day 1 and Day 6.
measure: Terminal Half-Life (T1/2)
timeFrame: Blood samples collected at 15 time points (including pre-dose) during the study period on Day 1 and Day 6.
Other outcomes:
Locations:
city: Dilworth
country: United States
facility: AXIS Clinicals
state: Minnesota
Study officials:
affiliation: Xspray Pharma AB
name: Per Andersson, PhD
role: STUDY_DIRECTOR
References: