PharmacokineticsPhase 1NCT05433896
Evaluating the Effects of Omeprazole on the Pharmacokinetics of XS004 (Dasatinib) Tablets in Healthy Adult Subjects Under Fasting Conditions
A Phase 1 study testing Dasatinib ASD and Omeprazole 40 MG in people with Pharmacokinetics and Drug Interactions, run by Xspray Pharma AB at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics, Drug Interactions
- What is being tested?
- Dasatinib ASD and Omeprazole 40 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2020to 19 Dec 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Pharmacokinetics, Drug Interactions
- Being tested
- Dasatinib ASD, Omeprazole 40 MG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dasatinib ASDDrug
XS004 Dasatinib Amorphous Solid Dispersion Film-Coated Tablet, 90 mg Test Formulation
Omeprazole 40 MGDrug
Omeprazole Delayed Release Capsules, USP 40 mg
| Study group | Role | What they receive |
|---|---|---|
| Dasatinib ASD alone | Experimental | 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. Receives: Drug: Dasatinib ASD |
| Dasatinib ASD + Omeprazole | Other | 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. Receives: Drug: Dasatinib ASD; Drug: Omeprazole 40 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
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.
Measured: Blood samples collected at 15 time points (including pre-dose) during the study period on Day 1 and Day 6.
Secondary outcomes (4)
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.
Measured: 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)
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.
Measured: Blood samples collected at 15 time points (including pre-dose) during the study period on Day 1 and Day 6.
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.
Measured: 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)
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.
Measured: Blood samples collected at 15 time points (including pre-dose) during the study period on Day 1 and Day 6.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start1 Nov 2020
- Primary completion19 Dec 2020
- Study completion19 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xspray Pharma AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Axis Clinicals Limited
- Responsible party
- Sponsor
- Investigators
- Per Andersson, PhD, Study director, Xspray Pharma AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05433896
- Sponsor's protocol ID
- XS004-09
- Status last verified
- Jun 2022
- First submitted
- 21 Jun 2022
- Last updated
- 27 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05433896
- Acronym / sponsor ID
- XS004-09
- Conditions
- Pharmacokinetics, Drug Interactions
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Xspray Pharma ABIndustry (pharma, biotech, devices)
- Collaborators
- Axis Clinicals Limited
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 19 Dec 2020 (actual)
- Study completion
- 19 Dec 2020 (actual)
- First posted
- 27 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dasatinib ASD alone | Experimental | Drug: Dasatinib ASDAt 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. |
| Dasatinib ASD + Omeprazole | Other | Drug: Dasatinib ASD, Drug: Omeprazole 40 MGAt 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dasatinib ASDXS004 Dasatinib Amorphous Solid Dispersion Film-Coated Tablet, 90 mg Test Formulation | Drug | Dasatinib ASD + Omeprazole, Dasatinib ASD alone |
| Omeprazole 40 MGOmeprazole Delayed Release Capsules, USP 40 mg | Drug | Dasatinib ASD + Omeprazole |
Primary outcome
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.
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.
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.
4 secondary outcomes
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Per Andersson, PhD study director
Xspray Pharma AB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dasatinib ASD and Omeprazole 40 MG in people with Pharmacokinetics and Drug Interactions, run by Xspray Pharma AB at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2022.