Drug-drug Interaction StudyPhase 1NCT06145217
An Drug-drug Interaction Study to Evaluate the Effects of Omeprazole 40mg on the Pharmacokinetics of SPRYCEL®
A Phase 1 study testing SPRYCEL® (dasatinib) 100 mg Film-Coated Tablets in combination with Omeprazole Delayed-Release Capsules USP, 40 mg in people with Drug-drug Interaction Study, run by Xspray Pharma AB at 1 site in India.
Trial summary
A drug-drug interaction study designed to evaluate the drug-drug interaction between SPRYCEL® 100 mg (US sourced) and Omeprazole in healthy, adult, human subjects Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug-drug Interaction Study
- What is being tested?
- SPRYCEL® (dasatinib) 100 mg Film-Coated Tablets in combination with Omeprazole Delayed-Release Capsules USP, 40 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteIndia
- Study dates
- 22 Aug 2023to 29 Aug 2023
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, adult, human beings 18 and 45 years of age.
- Subjects weighing at least 50 kg for male or 45 kg for female, having a body mass index between 18.5 Kg/m2 and 29.9 Kg/m2.
- Subject must be able to provide written informed consent with a detailed description of nature of the drug.
- Acceptable medical history, physical examination, Electrocardiography (ECG), laboratory investigations within 21 days prior to enrollment and chest X-ray.
- Female subjects must meet one of the following criteria:
- Physiological postmenopausal status, defined as the following. Absence of menses for at least one year prior to the first study drug administration (without an alternative medical condition); and FSH levels ≥40 mlU/mL during screening / at check-in or Surgical postmenopausal status. Must agree to use an adequate method of contraception. Bilateral tubal occlusion or hysterectomy
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- Clinical laboratory values should be within the laboratory's stated normal range.
- The subject is able to communicate meaningfully with study personnel and is anticipated to be able to comply fully with study procedures
- Male or Female subjects who participate in the study should agree to practice abstention or contraception during the study and for at least 90 days after the last dose of dasatinib.
- Male subjects should not donate sperm for 90 days from the last administration of IMP.
- Light, Non or ex-smoker
Who cannot join
- Systolic blood pressure less than 100 mm of Hg or more than 140 mm of Hg.
- Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg.
- Body temperature less than 95.0 °F (35.0 °C) or above 98.6°F (37.0 °C).
- Pulse rate less than 60/min or above 100/min.
- History of hypersensitivity or idiosyncratic reaction to investigational drug product or any other related drugs.
- Any history of impairment of cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, psychiatric disease, or disorder.
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- History of hematological, bleeding, and malignant disorders
- History of gastrointestinal disorders that may affect the absorption of the drug, including achlorhydria, hypochlorhydria, hypermotility, hypomotility, malabsorption disorder, diarrhoea, prior bowel resection, colostomy, and ileostomy.
- Subjects with estimated glomerular filtration rate < 90 mL/minute/1.73 m2 at screening or on the day of check-in.
- History of taking anticoagulant medication, antiarrhythmics and antiplatelet agents.
- A prolonged QTc interval (QTc greater than 450 ms) demonstrated on ECG at Screening.
- Volunteer has taken P-gp inhibitors within 30 days prior to the check-in.
- History of any drug or alcohol abuse in the past 2 years.
- History of intake of strong CYP3A4 inhibitors (see Appendix-5) or inducers within 4 weeks prior to the check-in.
- History of intake of drugs known to prolong the QTc interval within 4 weeks prior to the check-in (see Appendix-5).
- Patients with rare hereditary problems of galactose intolerance, severe lactase deficiency with a severe degree of intolerance to lactose-containing products, or of glucose-galactose malabsorption.
- Any clinically significant ECG abnormalities that, in the Investigator's opinion, would compromise the subject's safety.
- Regular alcohol consumption in males >21 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 units = 125 mL glass of wine, depending on type).
- History or family history of long QT syndrome.
- A history of difficulty with donating blood and having poor vein access.
- Male subjects with pregnant or lactating partners.
- Volunteers who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies, vitamins or minerals in the 14 days before check-in (other than up to 4 gr of paracetamol per day).
- Consumption of the xanthine containing food or beverages (like tea, coffee, chocolates, and flavored drinks) at least 48 hours before check-in.
- Consumption of the grapefruit or grapefruit juice, pomegranate, or pomegranate juice at least 14 days before check-in.
- Consumption of tobacco containing products (including smoking cigarettes or chewing tobacco products), e-cigarettes and/or nicotine replacement products within 3 months prior to the check-in.
- Consumption of all kinds of alcoholic beverages from at least 48.00 hours prior to check-in until the last blood sample collection in study period.
- Difficulty in abstaining from all kinds of alcoholic beverages during entire study period.
- Difficulty in abstaining from the xanthine containing food or beverages (like tea, coffee, chocolates, and flavored drinks), grapefruit or grapefruit juice, pomelo, pomegranate, or pomegranate juice during entire study period.
- Difficulty in abstaining from the smoking or chewing tobacco products during entire study period.
- Intake of any medication in last 30 days except caffeine, ranitidine, paracetamol, diclofenac sodium and ondansetron.
- Confirmed positive drugs of abuse (benzodiazepines, tetrahydrocannabinol, amphetamine, cocaine, barbiturates, and morphine) on check-in.
- Confirmed positive alcohol (breath) test on check-in.
- Confirmed positive Covid-19 Rapid Antigen test on check-in.
- Participated in any other clinical study or donated blood in last 90 days.
- Intake of pomelo, starfruit, Seville oranges, and St. John's Wort within the previous 14 days before check-in.
- Difficulty in abstaining from the pomelo, starfruit, Seville oranges, and St. John's Wort throughout the study.
- Positive screens for serum hepatitis B surface antigen (HbsAg), hepatitis C antibody (HepC) or human immunodeficiency virus (HIV).
- Participated in contact sports or unaccustomed strenuous exercise in the 72 hours before check-in of any period.
- History of clinically significant allergy.
- Females who are pregnant, lactating, or likely to become pregnant during the study.
- History of allergy or sensitivity to dasatinib, or history of any food or drug hypersensitivity or intolerance which, in the opinion of the Investigator, would compromise the safety of the subject or the study.
- History of chronic infectious disease, system disorders, organ dysfunction especially cardiovascular disorders (e.g., arterial vascular occlusive events), respiratory disorders, renal or hepatic disorders, diabetes, or obesity.
- Volunteers having greater than the upper limit of normal values of Alkaline phosphatase (ALP), alanine transaminase (ALT), aspartate aminotransferase (AST) and total bilirubin.
- Clinically significant hypokalemia, hypomagnesemia, or other electrolyte disorders.
- Volunteers with history of malignant disorders.
- Volunteers with history of hematological, bleeding disorders.
- Volunteers on anticoagulant therapy.
- History of gastrointestinal disease or history of malabsorption within the last year, as determined by the Investigator.
- Confirmed positive pregnancy test (for females) on check-in.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-label, Non-randomized, Two-treatment, Single-period, Single Dose, Drug-drug Interaction Study to Evaluate the Effects of Omeprazole 40mg on the Pharmacokinetics of SPRYCEL® 100 mg Film-coated Tablets (Dasatinib) in Adult Human Subjects
A drug-drug interaction study designed to evaluate the drug-drug interaction between SPRYCEL® 100 mg (US sourced) and Omeprazole in healthy, adult, human subjects
Read the detailed description
A drug-drug interaction study and was designed to evaluate the drug-drug interaction between SPRYCEL® 100 mg (US sourced) and Omeprazole in healthy, adult, human subjects under fasted conditions at a time point when a high pH effect of omeprazole is expected, i.e., omeprazole at steady state and dasatinib are administered 9 hours apart. 18 healthy, adult, human subjects were enrolled into the study. Forty (40) PK blood sampling time points and a washout period of 05 days (between two administration of the study drug SPRYCEL® 100mg) were planned so that the drug concentration in the biological fluid could be characterized accurately for this drug interaction study.
- Conditions
- Drug-drug Interaction Study
- Being tested
- SPRYCEL® (dasatinib) 100 mg Film-Coated Tablets in combination with Omeprazole Delayed-Release Capsules USP, 40 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPRYCEL® (dasatinib) 100 mg Film-Coated Tablets in combination with Omeprazole Delayed-Release Capsules USP, 40 mgDrug
Also called dasatinib
To evaluate the drug-drug interaction between SPRYCEL® 100 mg and Omeprazole under fasted conditions in healthy, adult, human subjects.
| Study group | Role | What they receive |
|---|---|---|
| SPRYCEL® (dasatinib) 100 mg Film-Coated Tablets | Experimental | To evaluate the drug-drug interaction between SPRYCEL® 100 mg (US sourced) and Omeprazole under fasted conditions in healthy, adult, human subjects. Receives: Drug: SPRYCEL® (dasatinib) 100 mg Film-Coated Tablets in combination with Omeprazole Delayed-Release Capsules USP, 40 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug-drug interaction Plasma Concentration (Cmax)
To evaluate the drug-drug interaction between SPRYCEL® 100 mg and Omeprazole in healthy, adult, human subjects under fasted conditions at a time point when a high pH effect of omeprazole is expected. Dasatinib (SPRYCEL®) concentration-time profiles will be evaluated using non-compartmental methods. Peak Plasma Concentration (Cmax) and tmax will be derived from the observed plasma concentration data.
Measured: a time point when a high potential hydrogen (pH) effect of omeprazole is expected, i.e., omeprazole at steady state and dasatinib are administered 9 hours apart.
Drug-drug interaction AUC0-t
To evaluate the drug-drug interaction between SPRYCEL® 100 mg and Omeprazole in healthy, adult, human subjects under fasted conditions at a time point when a high pH effect of omeprazole is expected. Dasatinib (SPRYCEL®) concentration-time profiles will be evaluated using non-compartmental methods. AUC0-t will be calculated using linear trapezoidal interpolation.
Measured: a time point when a high potential hydrogen (pH) effect of omeprazole is expected, i.e., omeprazole at steady state and dasatinib are administered 9 hours apart.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2023
- Study start22 Aug 2023
- Primary completion22 Aug 2023
- Study completion29 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug-drug Interaction StudyStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- An open-label, non-randomized, two-treatment, single-period, single dose, drug-drug interaction study, which allows for independent establishment of the true intrasubject variability for dasatinib
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xspray Pharma AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maria Klockare, Study director, Xspray Pharma AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06145217
- Sponsor's protocol ID
- XS004-17
- Status last verified
- Nov 2023
- First submitted
- 10 Nov 2023
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Non-randomized, Two-treatment, Single-period, Single Dose, Drug-drug Interaction Study to Evaluate the Effects of Omeprazole 40mg on the Pharmacokinetics of SPRYCEL® 100 mg Film-coated Tablets (Dasatinib) in Adult Human Subjects
- ClinicalTrials.gov ID
- NCT06145217
- Acronym / sponsor ID
- XS004-17
- Conditions
- Drug-drug Interaction Study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Xspray Pharma ABIndustry (pharma, biotech, devices)
- Study start
- 22 Aug 2023 (actual)
- Primary completion
- 22 Aug 2023 (actual)
- Study completion
- 29 Aug 2023 (actual)
- First posted
- 24 Nov 2023 (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.
A drug-drug interaction study designed to evaluate the drug-drug interaction between SPRYCEL® 100 mg (US sourced) and Omeprazole in healthy, adult, human subjects
Detailed description
A drug-drug interaction study and was designed to evaluate the drug-drug interaction between SPRYCEL® 100 mg (US sourced) and Omeprazole in healthy, adult, human subjects under fasted conditions at a time point when a high pH effect of omeprazole is expected, i.e., omeprazole at steady state and dasatinib are administered 9 hours apart. 18 healthy, adult, human subjects were enrolled into the study. Forty (40) PK blood sampling time points and a washout period of 05 days (between two administration of the study drug SPRYCEL® 100mg) were planned so that the drug concentration in the biological fluid could be characterized accurately for this drug interaction study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- An open-label, non-randomized, two-treatment, single-period, single dose, drug-drug interaction study, which allows for independent establishment of the true intrasubject variability for dasatinib
| Arm | Type | Receives |
|---|---|---|
| SPRYCEL® (dasatinib) 100 mg Film-Coated Tablets | Experimental | Drug: SPRYCEL® (dasatinib) 100 mg Film-Coated Tablets in combination with Omeprazole Delayed-Release Capsules USP, 40 mgTo evaluate the drug-drug interaction between SPRYCEL® 100 mg (US sourced) and Omeprazole under fasted conditions in healthy, adult, human subjects. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Healthy, adult, human beings 18 and 45 years of age.
- Subjects weighing at least 50 kg for male or 45 kg for female, having a body mass index between 18.5 Kg/m2 and 29.9 Kg/m2.
- Subject must be able to provide written informed consent with a detailed description of nature of the drug.
- Acceptable medical history, physical examination, Electrocardiography (ECG), laboratory investigations within 21 days prior to enrollment and chest X-ray.
- Female subjects must meet one of the following criteria:
Key exclusion criteria (49 listed)
- Systolic blood pressure less than 100 mm of Hg or more than 140 mm of Hg.
- Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg.
- Body temperature less than 95.0 °F (35.0 °C) or above 98.6°F (37.0 °C).
- Pulse rate less than 60/min or above 100/min.
- History of hypersensitivity or idiosyncratic reaction to investigational drug product or any other related drugs.
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 |
|---|---|---|
| SPRYCEL® (dasatinib) 100 mg Film-Coated Tablets in combination with Omeprazole Delayed-Release Capsules USP, 40 mgAlso: dasatinibTo evaluate the drug-drug interaction between SPRYCEL® 100 mg and Omeprazole under fasted conditions in healthy, adult, human subjects. | Drug | SPRYCEL® (dasatinib) 100 mg Film-Coated Tablets |
Primary outcome
Drug-drug interaction Plasma Concentration (Cmax)
Time frame: a time point when a high potential hydrogen (pH) effect of omeprazole is expected, i.e., omeprazole at steady state and dasatinib are administered 9 hours apart.
To evaluate the drug-drug interaction between SPRYCEL® 100 mg and Omeprazole in healthy, adult, human subjects under fasted conditions at a time point when a high pH effect of omeprazole is expected. Dasatinib (SPRYCEL®) concentration-time profiles will be evaluated using non-compartmental methods. Peak Plasma Concentration (Cmax) and tmax will be derived from the observed plasma concentration data.
Drug-drug interaction AUC0-t
Time frame: a time point when a high potential hydrogen (pH) effect of omeprazole is expected, i.e., omeprazole at steady state and dasatinib are administered 9 hours apart.
To evaluate the drug-drug interaction between SPRYCEL® 100 mg and Omeprazole in healthy, adult, human subjects under fasted conditions at a time point when a high pH effect of omeprazole is expected. Dasatinib (SPRYCEL®) concentration-time profiles will be evaluated using non-compartmental methods. AUC0-t will be calculated using linear trapezoidal interpolation.
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 24 Nov 2023.
- 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.
Maria Klockare 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 SPRYCEL® (dasatinib) 100 mg Film-Coated Tablets in combination with Omeprazole Delayed-Release Capsules USP, 40 mg in people with Drug-drug Interaction Study, run by Xspray Pharma AB at 1 site in India.
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 11 inclusion and 49 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 24 Nov 2023. 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 India. 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?
Drug-drug interaction Plasma Concentration (Cmax) (time frame: a time point when a high potential hydrogen (pH) effect of omeprazole is expected, i.e., omeprazole at steady state and dasatinib are administered 9 hours apart.). The study lists 2 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 24 Nov 2023.