- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05433896
Evaluating the Effects of Omeprazole on the Pharmacokinetics of XS004 (Dasatinib) Tablets in Healthy Adult Subjects Under Fasting Conditions
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Minnesota
-
Dilworth, Minnesota, United States, 56529-1342
- AXIS Clinicals
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dasatinib ASD alone
At the clinic, participants were administered a single oral dose of 90 mg Dasatinib (Amorphous Solid Dispersion Film-Coated Tablet) on Day 1 after an overnight fast of at least 9 hours.
Dasatinib was given with approximately 240 mL of room temperature water.
Fasting continued for at least 4 hours following drug administration, after which a standardized lunch was served.
|
XS004 Dasatinib Amorphous Solid Dispersion Film-Coated Tablet, 90 mg Test Formulation
|
Other: Dasatinib ASD + Omeprazole
At the clinic, on Day 2 to Day 6, participants were administered a single oral dose of Omeprazole 40 mg × 1 Delayed Release Capsule once before meals in the evening with approximately 150 mL of room temperature water. No food was allowed two hours before and one hour after administration of Omeprazole. In addition, participants were administered a single oral dose of 90 mg Dasatinib (Amorphous Solid Dispersion Film-Coated Tablet) on Day 6 after an overnight fast of at least 9 hours. Dasatinib was given with approximately 240 mL of room temperature water. Fasting continued for at least 4 hours following drug administration, after which a standardized lunch was served. |
XS004 Dasatinib Amorphous Solid Dispersion Film-Coated Tablet, 90 mg Test Formulation
Omeprazole Delayed Release Capsules, USP 40 mg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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
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.
|
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
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.
|
Blood samples collected at 15 time points (including pre-dose) during the study period on Day 1 and Day 6.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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)
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.
|
Blood samples collected at 15 time points (including pre-dose) during the study period on Day 1 and Day 6.
|
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.
|
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)
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.
|
Blood samples collected at 15 time points (including pre-dose) during the study period on Day 1 and Day 6.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Per Andersson, PhD, Xspray Pharma AB
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- XS004-09
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pharmacokinetics
-
Astellas Pharma Global Development, Inc.Basilea Pharmaceutica International LtdCompletedHealthy Subjects | Pharmacokinetics of Isavuconazole | Pharmacokinetics of Methotrexate | Pharmacokinetics of 7-hydroxymethotrexateUnited States
-
Astellas Pharma IncCompletedHealthy | Pharmacokinetics of ASP1941 | Pharmacokinetics of MitiglinideJapan
-
Astellas Pharma Global Development, Inc.Basilea Pharmaceutica International LtdCompletedHealthy Volunteers | Pharmacokinetics of Isavuconazole | Pharmacokinetics of MethadoneUnited States
-
Astellas Pharma IncBasilea PharmaceuticaCompletedHealthy Volunteers | Pharmacokinetics of Isavuconazole | Pharmacokinetics of MidazolamUnited States
-
Astellas Pharma Global Development, Inc.Basilea Pharmaceutica International LtdCompletedHealthy Volunteers | Pharmacokinetics of Isavuconazole | Pharmacokinetics of DigoxinUnited States
-
Astellas Pharma Global Development, Inc.Basilea Pharmaceutica International LtdCompletedHealthy Volunteers | Pharmacokinetics of Isavuconazole | Pharmacokinetics of BupropionUnited States
-
Astellas Pharma Global Development, Inc.Basilea Pharmaceutica International LtdCompletedHealthy Subjects | Pharmacokinetics of Isavuconazole | Pharmacokinetics of SirolimusUnited States
-
Astellas Pharma Global Development, Inc.Basilea Pharmaceutica International LtdCompletedHealthy Volunteers | Pharmacokinetics of Isavuconazole | Pharmacokinetics of AtorvastatinUnited States
-
Astellas Pharma Global Development, Inc.Basilea Pharmaceutica International LtdCompletedHealthy Subjects | Pharmacokinetics of Caffeine | Pharmacokinetics of RepaglinideUnited States
-
Astellas Pharma Global Development, Inc.Basilea Pharmaceutica International LtdCompletedHealthy Subjects | Pharmacokinetics of Isavuconazole | Pharmacokinetics of MetforminUnited States
Clinical Trials on Dasatinib ASD
-
Xspray Pharma ABQPS Bioserve India Pvt LimitedCompleted
-
Virginia Commonwealth UniversityNational Institute on Disability, Independent Living, and Rehabilitation...CompletedAutism Spectrum Disorder | Autism | Asperger Syndrome | Pervasive Developmental Disorder | Adolescent Development
-
Virginia Commonwealth UniversityHenrico County Public Schools; Virginia Department of Aging and Rehabilitative... and other collaboratorsCompleted
-
Virginia Commonwealth UniversityUnited States Department of DefenseCompletedAutism Spectrum DisorderUnited States
-
Rutgers, The State University of New JerseyGovernor's Council for Medical Research and Treatment of AutismCompletedDepression | Depressive Symptoms | Autism Spectrum DisorderUnited States
-
Ludwig-Maximilians - University of MunichUnknown
-
Shanghai Zhongshan HospitalRecruiting
-
University of Sao PauloCompleted
-
atHeart MedicalRecruitingHeart Diseases | Cardiovascular Diseases | Congenital Abnormalities | Heart Septal Defects, Atrial | Heart Defects, Congenital | Cardiovascular Abnormalities | Heart Septal DefectUnited States, France
-
Cognoa, Inc.Withdrawn