CancerPhase 1XS003-14NCT07138352
Bioavailability Study of XS003 (Nilotinib)
A Phase 1 study testing XS003 under fed and fasted condition in people with Cancer, run by Xspray Pharma AB at 1 site in United States.
Trial summary
An open label, single-center, randomized, two-treatment, two-period, two-sequence, single dose, crossover, study under fasted and fed conditions. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- XS003 under fed and fasted condition
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2024to 8 Jan 2025
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- A willing study participant to become eligible for the study must fulfil all of the below inclusion criteria.
- Healthy, human beings 18 and 55 years of age inclusive at the time of screening.
- Subjects, having a body mass index between ≥18.0 kg/m2 and <32.0 kg/m2.
- Subjects must be able to provide written informed consent.
- Acceptable medical history, physical examination, ECG, laboratory investigations per the Investigator.
- Female subjects must meet at least one of the following requirements:
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- Agree to abstain from sexual intercourse from screening, throughout the duration of the study and for at least 90 days after the last study drug administration.
- Have used and agree to continue to use a reliable method of contraception (e.g., hormonal contraceptives, condom with spermicide, IUD) for at least 30 days before initial dosing, throughout the duration of the study and for at least 90 days after the last study drug administration.
- Surgically sterile (bilateral oophorectomy or hysterectomy, bilateral tubal ligation at least 3 months before initial dosing or Essure® device placement).
- At least 1 year postmenopausal and have a documented FSH level ≥ 40 mIU/mL at screening.
- Male subjects who are not surgically sterile must agree to abstain from sexual intercourse (complete abstinence) or use appropriate contraceptive measures and agree to not impregnate a female partner(s) and not to donate sperm throughout the entire study, including the washout periods, and for at least 90 days after the last study drug administration. Examples of acceptable methods of contraception include a double-barrier method of contraception (e.g., condom with spermicide). Other forms of contraception may be acceptable, at the discretion of the Investigator.
- 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 (with the exception of those labs specifically listed in Section 9.2.).
- The subject is able to communicate meaningfully with study personnel and is anticipated to be able to comply fully with study procedures and must be willing and able to communicate and participate in the whole study.
- Male subjects should not donate sperm during the study and for 90 days after the last administration of IMP.
Who cannot join
- A willing study participant will be excluded from the study, if any of the below criteria is met.
- Systolic blood pressure is less than 100 mm of Hg or more than 140 mm of Hg.
- Diastolic blood pressure is less than 60 mm of Hg or more than 90 mm of Hg.
- Note: If vital signs are out-of-range, the investigator may obtain one additional reading so that up to 2 consecutive assessments are made within 1.00 hour with the subject seated quietly during the 5 minutes preceding the assessment.
- Body temperature less than 95.0 °F (35.0 °C) or more than 98.6°F (37.0°C).
- Heart rate less than 60/min or more than 100/min.
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- History of hypersensitivity or idiosyncratic reaction to investigational drug product or any other related drugs.
- History of malignancy, cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, or psychiatric disease or disorder considered clinically significant in the opinion of the Investigator.
- Taken drugs that are substrates or inhibitors of P-glycoproteins in last 30 days prior to the check-in.
- History of hematological, malignant, and bleeding disorders.
- On anticoagulant therapy, within 4 weeks prior to the check-in.
- History of hypokalemia, hypomagnesemia, or a history of cardiac disease.
- History of cholecystectomy or gall stones.
- History of any drug or alcohol abuse in the past 2 years.
- History of intake of strong CYP3A4 inhibitors (see Table 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
- History of rare hereditary problems of galactose intolerance, severe lactase deficiency with a severe degree of intolerance to lactose-containing products, or of glucose- galactose malabsorption.
- A prolonged QTc interval (QTcF greater than 450 msec demonstrated on ECG at Screening.)
- Any clinically significant ECG abnormalities that, in the Investigator's opinion, would compromise the subject's safety.
- History or family history of long QT syndrome.
- Significant history or current evidence of risk factors for Torsade de Pointes (TdP).
- History of Gilbert syndrome.
- Having poor vein access.
- Male subjects with pregnant or breastfeeding partners.
- Taking, or have taken, any prescribed or over-the-counter drug or herbal remedies, vitamins, or minerals and intake of any medication except caffeine, ranitidine, paracetamol, diclofenac sodium and ondansetron within 14 days before check-in (other than up to 4 g of paracetamol/acetaminophen per day).
- Consumption of xanthine containing food or beverages (like tea, coffee, chocolates, and flavored drinks) within 48 hours before check-in of each period.
- Consumption of grapefruit or grapefruit juice, pomegranate, or pomegranate juice, pomelo, starfruit, Seville oranges and St. John's Wort within 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 before check-in.
- Consumption of alcoholic beverages within 48 hours before check-in.
- Positive drugs of abuse screen at Screening or upon check-in of any period. Based on local regulations, if positive for tetrahydrocannabinol, evaluation will be performed by the PI based on last usage date (must be at least 14 days prior to the initial dosing and throughout the duration of the entire study period).
- Positive alcohol (breath or urine) test screen at screening or upon check-in of any period.
- Positive urine cotinine test screen at screening or upon check-in of any period.
- Participated in any other clinical study or donated blood within 30 days before check-in.
- Positive screens for serum Hepatitis B virus surface antigen (HBsAg), Hepatitis C virus antibody ( HCV Ab) or Human Immunodeficiency Virus (HIV-1 \& 2).
- Participated in contact sports or unaccustomed strenuous exercise within 72 hours before check-in of any period.
- History of clinically significant allergy or any allergy or sensitivity to nilotinib, 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.
- Significant history or current evidence 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.
- Subjects with greater than the safety laboratory upper limit of normal values of ALP, ALT, AST and total bilirubin.
- Estimated glomerular filtration rate (eGFR) < 90 mL/min at screening
- Subjects with less than the safety laboratory lower limit of normal values for potassium or magnesium.
- Clinically significant history or presence of gastrointestinal disease or history of malabsorption within the last year, as determined by the Investigator.
- Positive pregnancy test (for females) at screening or upon check-in of any period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Single-center, Randomized, Two-treatment, Two-period, Two-sequence, Single Dose, Crossover Study to Evaluate the Oral Comparative Bioavailability of XS003 (Nilotinib) Capsules 192 mg Under Fasted and Fed Conditions in Healthy, Adult Subjects.
An open label, single-center, randomized, two-treatment, two-period, two-sequence, single dose, crossover, study under fasted and fed conditions.
Read the detailed description
This is a single-dose, open-label, randomized, crossover study to evaluate the comparative oral bioavailability of XS003 (nilotinib) Capsules 192 mg (4X 48 mg) of Xspray Pharma AB, Sweden under fasted conditions comparing with XS003 (nilotinib) Capsules 192 mg (4X 48 mg) of Xspray Pharma AB, Sweden in healthy, adult, human subjects under fed conditions.
This will enroll up to 48 healthy, adult, human subjects. Each sequence will enroll 24 healthy, adult, human subjects. There will be at least 10 days between each drug administration.
Adverse events will be recorded from the signing of ICF throughout the study. In each period, the subjects will be housed for approximately 14 hours before and at least 24 hours after the drug administration. Subjects will return to clinical facility for ambulatory samples at 48.00, 72.00, 96.00 and 120.00 hours post dose.
- Conditions
- Cancer
- Being tested
- XS003 under fed and fasted condition
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XS003 under fed and fasted conditionDrug
XS003 under fed and fasted condition
| Study group | Role | What they receive |
|---|---|---|
| XS003 fasted condition | Experimental | XS003 (nilotinib) Capsules 192 mg (4X 48 mg) under fasted conditions. Receives: Drug: XS003 under fed and fasted condition |
| XS003 fed condition | Experimental | XS003 (nilotinib) Capsules 192 mg (4X 48 mg) under fed conditions Receives: Drug: XS003 under fed and fasted condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the comparative bioavailability Cmax of XS003 (nilotinib) Capsules 192 mg (4X 48 mg) under fasted and fed conditions in healthy, adult, human subjects.
Primary PK endpoints: Cmax: Maximum measured analyte concentration in the biological fluid.
Measured: PK samples will be collected at pre-dose (0.00) and between 0.50 and 120.00 hours post dose
To evaluate the comparative bioavailability AUC of XS003 (nilotinib) Capsules 192 mg (4X 48 mg) under fasted and fed conditions in healthy, adult, human subjects.
Primary PK endpoints: AUC0-t: Time of the maximum observed drug concentration.
Measured: PK samples will be collected at pre-dose (0.00) and between 0.50 and 120.00 hours post dose
Secondary outcomes (2)
To evaluate the safety (adverse events (AE)) of XS003 (nilotinib) Capsules 192 mg (4X 48 mg) under fasted and fed conditions in healthy, adult, human subjects.
To collect data on treatment related and non treatment related adverse events as assessed by CTCAE v4.0"
Measured: From Screening until end of study, i.e. up to 56days
To evaluate the safety and tolerability (ECG, elektrocardiogram) of XS003 (nilotinib) Capsules 192 mg (4X 48 mg) under fasted and fed conditions in healthy, adult, human subjects.
Safety variables collection will include ECG, elektrocardiogram QT Interval
Measured: From Screening until end of study, i.e. up to 56days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start3 Oct 2024
- Primary completion8 Jan 2025
- Study completion8 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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
- Randomised
- Intervention model
- Crossover
- Model description
- This is a single-dose, open-label, randomized, crossover study to evaluate the comparative oral bioavailability of XS003 (nilotinib) Capsules 192 mg (4X 48 mg) of Xspray Pharma AB, Sweden under fasted conditions comparing with XS003 (nilotinib) Capsules 192 mg (4X 48 mg) of Xspray Pharma AB, Sweden in healthy, adult, human subjects under fed conditions.
- Masking
- None (open label)
- Enrolment
- 48 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07138352
- Sponsor's protocol ID
- XS003-14
- Acronym
- XS003-14
- Status last verified
- Aug 2025
- First submitted
- 29 Jul 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: This is an Bioavailibility study so IPD is N/A
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-center, Randomized, Two-treatment, Two-period, Two-sequence, Single Dose, Crossover Study to Evaluate the Oral Comparative Bioavailability of XS003 (Nilotinib) Capsules 192 mg Under Fasted and Fed Conditions in Healthy, Adult Subjects.
- ClinicalTrials.gov ID
- NCT07138352
- Acronym / sponsor ID
- XS003-14 / XS003-14
- Conditions
- Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Xspray Pharma ABIndustry (pharma, biotech, devices)
- Study start
- 3 Oct 2024 (actual)
- Primary completion
- 8 Jan 2025 (actual)
- Study completion
- 8 Jan 2025 (actual)
- First posted
- 22 Aug 2025 (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.
An open label, single-center, randomized, two-treatment, two-period, two-sequence, single dose, crossover, study under fasted and fed conditions.
Detailed description
This is a single-dose, open-label, randomized, crossover study to evaluate the comparative oral bioavailability of XS003 (nilotinib) Capsules 192 mg (4X 48 mg) of Xspray Pharma AB, Sweden under fasted conditions comparing with XS003 (nilotinib) Capsules 192 mg (4X 48 mg) of Xspray Pharma AB, Sweden in healthy, adult, human subjects under fed conditions.
This will enroll up to 48 healthy, adult, human subjects. Each sequence will enroll 24 healthy, adult, human subjects. There will be at least 10 days between each drug administration.
Adverse events will be recorded from the signing of ICF throughout the study. In each period, the subjects will be housed for approximately 14 hours before and at least 24 hours after the drug administration. Subjects will return to clinical facility for ambulatory samples at 48.00, 72.00, 96.00 and 120.00 hours post dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a single-dose, open-label, randomized, crossover study to evaluate the comparative oral bioavailability of XS003 (nilotinib) Capsules 192 mg (4X 48 mg) of Xspray Pharma AB, Sweden under fasted conditions comparing with XS003 (nilotinib) Capsules 192 mg (4X 48 mg) of Xspray Pharma AB, Sweden in healthy, adult, human subjects under fed conditions.
| Arm | Type | Receives |
|---|---|---|
| XS003 fasted condition | Experimental | Drug: XS003 under fed and fasted conditionXS003 (nilotinib) Capsules 192 mg (4X 48 mg) under fasted conditions. |
| XS003 fed condition | Experimental | Drug: XS003 under fed and fasted conditionXS003 (nilotinib) Capsules 192 mg (4X 48 mg) under fed conditions |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- A willing study participant to become eligible for the study must fulfil all of the below inclusion criteria.
- Healthy, human beings 18 and 55 years of age inclusive at the time of screening.
- Subjects, having a body mass index between ≥18.0 kg/m2 and <32.0 kg/m2.
- Subjects must be able to provide written informed consent.
- Acceptable medical history, physical examination, ECG, laboratory investigations per the Investigator.
Key exclusion criteria (42 listed)
- A willing study participant will be excluded from the study, if any of the below criteria is met.
- Systolic blood pressure is less than 100 mm of Hg or more than 140 mm of Hg.
- Diastolic blood pressure is less than 60 mm of Hg or more than 90 mm of Hg.
- Note: If vital signs are out-of-range, the investigator may obtain one additional reading so that up to 2 consecutive assessments are made within 1.00 hour with the subject seated quietly during the 5 minutes preceding the assessment.
- Body temperature less than 95.0 °F (35.0 °C) or more than 98.6°F (37.0°C).
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 |
|---|---|---|
| XS003 under fed and fasted conditionXS003 under fed and fasted condition | Drug | XS003 fasted condition, XS003 fed condition |
Primary outcome
To evaluate the comparative bioavailability Cmax of XS003 (nilotinib) Capsules 192 mg (4X 48 mg) under fasted and fed conditions in healthy, adult, human subjects.
Time frame: PK samples will be collected at pre-dose (0.00) and between 0.50 and 120.00 hours post dose
Primary PK endpoints: Cmax: Maximum measured analyte concentration in the biological fluid.
To evaluate the comparative bioavailability AUC of XS003 (nilotinib) Capsules 192 mg (4X 48 mg) under fasted and fed conditions in healthy, adult, human subjects.
Time frame: PK samples will be collected at pre-dose (0.00) and between 0.50 and 120.00 hours post dose
Primary PK endpoints: AUC0-t: Time of the maximum observed drug concentration.
2 secondary outcomes
To evaluate the safety (adverse events (AE)) of XS003 (nilotinib) Capsules 192 mg (4X 48 mg) under fasted and fed conditions in healthy, adult, human subjects.
Time frame: From Screening until end of study, i.e. up to 56days
To evaluate the safety and tolerability (ECG, elektrocardiogram) of XS003 (nilotinib) Capsules 192 mg (4X 48 mg) under fasted and fed conditions in healthy, adult, human subjects.
Time frame: From Screening until end of study, i.e. up to 56days
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 22 Aug 2025.
- Individual participant dataSharing planned: No. This is an Bioavailibility study so IPD is N/A
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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
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 XS003 under fed and fasted condition in people with Cancer, 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 14 inclusion and 42 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 22 Aug 2025. 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?
To evaluate the comparative bioavailability Cmax of XS003 (nilotinib) Capsules 192 mg (4X 48 mg) under fasted and fed conditions in healthy, adult, human subjects. (time frame: PK samples will be collected at pre-dose (0.00) and between 0.50 and 120.00 hours post dose). 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 22 Aug 2025.