CancerPhase 1XS003-11NCT07138378
A Bioavailability Study of Nilotinib in Healthy, Adult, Human Subjects Under Fasted Conditions.
A Phase 1 study testing XS003 (nilotinib) and Tasigna (nilotinib) in people with Cancer, run by Xspray Pharma AB at 1 site in India.
Trial summary
An open label, single-center, balanced, randomized, four-treatment, four-sequence, four-period, single dose, crossover, comparative bioavailability study in healthy, adult, human subjects under fasteding conditions Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- XS003 (nilotinib) and Tasigna (nilotinib)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteIndia
- Study dates
- 15 Nov 2024to 15 Dec 2024
- 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
- A willing study participant to become eligible for the study must fulfill all of the below inclusion criteria:
- Healthy, human beings 18 and 45 years of age (both inclusive).
- Subjects weighing at least 50 kg, having a body mass index between 18.5 Kg/m2 and 29.9 Kg/m2 (both inclusive).
- Subject must be able to provide written informed consent with a detailed description of nature of the drug.
- Acceptable medical history, physical examination, ECG, laboratory investigations within 21 days prior to enrollment and chest X-ray (Valid for 180 days).
- Female subjects must meet one of the following criteria:
Show all 25Show fewer
- 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 at screening or
- Surgical postmenopausal status, defined as the following.
- Bilateral Oophorectomy and
- Absence of menses for at least 90 days prior to the screening or
- Post hysterectomy status
- If postmenopausal and has an FSH of < 40 mlU/mL, but meets all other criteria in (i), (ii) or (iii) above as well as all the other inclusion criteria, screening estradiol serum level must be ≤ 150 pmol/L.
- or
- iv.Surgically rendered non-childbearing potential by bilateral tubal ligation
- Must agree to use an adequate method of contraception. Subjects who are sexually active must use, with their partner, a condom AND one of the following methods of highly effective contraception from the time of IMP administration until 90 days after the last dose of IMP
- oral (except low-doselow dose gestagen (lynestrenol and norestisteron)), injectable or implanted hormonal contraceptives
- intrauterine device or system (e.g., progestin-releasing coil)
- vasectomized male (with appropriate post vasectomy documentation of the absence of sperm in the ejaculate)
- bilateral tubal occlusion or hysterectomy
- 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.
- 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.
- Non-smokers .
Who cannot join
- A willing study participant will be excluded from the study, if any of the below criteria is met:
- 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.
- 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).
- Radial Pulse rate less than 60/min or more than 100/min.
Show all 50Show fewer
- 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.
- Taken drugs that are substrates or inhibitors of P-glycoproteins in last 30 days prior to the check-in (see Appendix-5).
- History of hematological, malignant, and bleeding disorders.
- On anticoagulant therapy.
- 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 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
- 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 (QTc 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.
- 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.
- Significant history or current evidence of risk factors for Torsade de Pointes (TdP).
- History of Gilbert syndrome.
- A history of difficulty with donating blood and having poor vein access.
- Male subjects with pregnant or lactating 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 in the 30 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 of each period.
- Consumption of the grapefruit or grapefruit juice, pomegranate, or pomegranate juice, pomelo, starfruit, Seville oranges and St. John's Wort at least 14 days before check-in of each period.
- 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.
- 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, pomelo, starfruit, Seville oranges and St. John's Wort during entire study period.
- Difficulty in abstaining from the smoking or chewing tobacco products during entire study period.
- Confirmed positive for drugs of abuse (benzodiazepines, tetrahydrocannabinol, amphetamine, cocaine, barbiturates, and morphine) on check-in of any period.
- Confirmed positive alcohol (breath) test on check-in of any period.
- Confirmed positive urine cotinine test on check-in of any period.
- Participated in any other clinical study or donated blood in last 90 days.
- 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.
- History of 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.
- Greater than the upper limit of normal values of Alkaline phosphatase (ALP), alanine transaminase (ALT), aspartate aminotransferase (AST) and total bilirubin.
- Estimated glomerular filtration rate (eGFR) < 90 mL/min/1.73 m2 at period-1
- check-in.
- Clinically significant hypokalemia, hypomagnesemia, or other electrolyte disorders.
- Clinically significant history or presence of gastrointestinal disease or history of malabsorption within the last year, as determined by the Investigator.
- Females who are pregnant, lactating, or likely to become pregnant during the study.
- Confirmed positive pregnancy test (for females) on check-in of any period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Randomized, Four-treatment, Four-period, Four-sequence, Single Dose, Crossover Study to Evaluate the Dose Adjusted Relative Bioavailability of Nilotinib Following the Oral Administration of Tasigna 200 mg Capsules, Tasigna 400 mg, XS003 (Nilotinib) Capsules 96mg and 192mg in Healthy, Adult Subjects Under Fasted Conditions
An open label, single-center, balanced, randomized, four-treatment, four-sequence, four-period, single dose, crossover, comparative bioavailability study in healthy, adult, human subjects under fasteding conditions
Read the detailed description
To evaluate the relative bioavailability of XS003 capsules 2x48mg (96mg) versus Tasigna 200 mg, and XS003 capsules 4x48mg versus Tasigna 400 mg after a single dose under fasted conditions in healthy, adult, human subjects.
- Conditions
- Cancer
- Being tested
- XS003 (nilotinib), Tasigna (nilotinib)
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XS003 (nilotinib)Drug
To evaluate the PK dose proportionality of Tasigna 200 mg versus Tasigna 400 mg and XS003 capsules 2x48mg (96mg) versus XS003 capsules 4x48mg (192mg).
Tasigna (nilotinib)Drug
To evaluate the PK dose proportionality of Tasigna 200 mg versus Tasigna 400 mg and XS003 capsules 2x48mg (96mg) versus XS003 capsules 4x48mg (192mg).
| Study group | Role | What they receive |
|---|---|---|
| Tasigna 200 mg | Active comparator | A single oral dose of Treatment Tasigna 200 mg Receives: Drug: XS003 (nilotinib); Drug: Tasigna (nilotinib) |
| Tasigna 400 mg | Active comparator | A single oral dose of Treatment Tasigna 400 mg Receives: Drug: XS003 (nilotinib); Drug: Tasigna (nilotinib) |
| XS003 (nilotinib) 96mg | Experimental | A single oral dose of Treatment XS003 Capsules 2x48mg (96mg) Receives: Drug: XS003 (nilotinib); Drug: Tasigna (nilotinib) |
| XS003 (nilotinib) 192mg | Experimental | A single oral dose of Treatment XS003 Capsules 4x48mg (192mg) Receives: Drug: XS003 (nilotinib); Drug: Tasigna (nilotinib) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioavailability (Peak Plasma Concentration (Cmax)) of XS003 versus Tasigna treatment
To evaluate the relative bioavailability (Peak Plasma Concentration (Cmax)) of XS003 capsules 2x48mg (96mg) versus Tasigna 200 mg, and XS003 capsules 4x48mg versus Tasigna 400 mg after a single dose under fasted conditions in healthy, adult, human subjects.
Measured: PK samples will be collected at pre-dose (0.00) and between 0.50 and 120.00 hours post dose
Bioavailability (Area under the plasma concentration versus time curve (AUC)) of XS003 versus Tasigna treatment
To evaluate the relative bioavailability (Area under the plasma concentration versus time curve (AUC)) of XS003 capsules 2x48mg (96mg) versus Tasigna 200 mg, and XS003 capsules 4x48mg versus Tasigna 400 mg after a single dose under fasted conditions in healthy, adult, human subjects.
Measured: PK samples will be collected at pre-dose (0.00) and between 0.50 and 120.00 hours post dose
Secondary outcomes (2)
Safety (adverse events (AE)) of XS003 versus Tasigna treatment
To evaluate the safety and tolerability (adverse events (AE, i.e treatment and non-treatment related adverse events as assessed by CTCAE v4.0)) of Tasigna 200 mg, Tasigna 400 mg, XS003 Capsules 2x48mg (96mg) and 4x48mg (192mg) in healthy, adult, human subjects under fasted conditions.
Measured: From baseline up to 58 days
Safety (electrokardiografi ECG)) of XS003 versus Tasigna treatment
To evaluate the safety and tolerability (electrokardiografi ECG QT Interval)) of Tasigna 200 mg, Tasigna 400 mg, XS003 Capsules 2x48mg (96mg) and 4x48mg (192mg) in healthy, adult, human subjects under fasted conditions
Measured: From baseline up to 58 days
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 start15 Nov 2024
- Primary completion15 Dec 2024
- Study completion15 Dec 2024
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
- An open label, single-center, balanced, randomized, four-treatment, four-sequence, four-period, single dose, crossover, dose proportional study in healthy, adult, human subjects under fasting conditions.
- Masking
- None (open label)
- Enrolment
- 128 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
- NCT07138378
- Sponsor's protocol ID
- XS003-11
- Acronym
- XS003-11
- 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
- No
- FDA-regulated device
- No
- Individual data sharing
- No: N/A as this is a Bioavailibility study
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, Randomized, Four-treatment, Four-period, Four-sequence, Single Dose, Crossover Study to Evaluate the Dose Adjusted Relative Bioavailability of Nilotinib Following the Oral Administration of Tasigna 200 mg Capsules, Tasigna 400 mg, XS003 (Nilotinib) Capsules 96mg and 192mg in Healthy, Adult Subjects Under Fasted Conditions
- ClinicalTrials.gov ID
- NCT07138378
- Acronym / sponsor ID
- XS003-11 / XS003-11
- Conditions
- Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Xspray Pharma ABIndustry (pharma, biotech, devices)
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 15 Dec 2024 (actual)
- Study completion
- 15 Dec 2024 (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, balanced, randomized, four-treatment, four-sequence, four-period, single dose, crossover, comparative bioavailability study in healthy, adult, human subjects under fasteding conditions
Detailed description
To evaluate the relative bioavailability of XS003 capsules 2x48mg (96mg) versus Tasigna 200 mg, and XS003 capsules 4x48mg versus Tasigna 400 mg after a single dose under fasted conditions in healthy, adult, human subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- An open label, single-center, balanced, randomized, four-treatment, four-sequence, four-period, single dose, crossover, dose proportional study in healthy, adult, human subjects under fasting conditions.
| Arm | Type | Receives |
|---|---|---|
| Tasigna 200 mg | Active comparator | Drug: XS003 (nilotinib), Drug: Tasigna (nilotinib)A single oral dose of Treatment Tasigna 200 mg |
| Tasigna 400 mg | Active comparator | Drug: XS003 (nilotinib), Drug: Tasigna (nilotinib)A single oral dose of Treatment Tasigna 400 mg |
| XS003 (nilotinib) 96mg | Experimental | Drug: XS003 (nilotinib), Drug: Tasigna (nilotinib)A single oral dose of Treatment XS003 Capsules 2x48mg (96mg) |
| XS003 (nilotinib) 192mg | Experimental | Drug: XS003 (nilotinib), Drug: Tasigna (nilotinib)A single oral dose of Treatment XS003 Capsules 4x48mg (192mg) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (25 listed)
- A willing study participant to become eligible for the study must fulfill all of the below inclusion criteria:
- Healthy, human beings 18 and 45 years of age (both inclusive).
- Subjects weighing at least 50 kg, having a body mass index between 18.5 Kg/m2 and 29.9 Kg/m2 (both inclusive).
- Subject must be able to provide written informed consent with a detailed description of nature of the drug.
- Acceptable medical history, physical examination, ECG, laboratory investigations within 21 days prior to enrollment and chest X-ray (Valid for 180 days).
Key exclusion criteria (50 listed)
- A willing study participant will be excluded from the study, if any of the below criteria is met:
- 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.
- 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 (nilotinib)To evaluate the PK dose proportionality of Tasigna 200 mg versus Tasigna 400 mg and XS003 capsules 2x48mg (96mg) versus XS003 capsules 4x48mg (192mg). | Drug | Tasigna 200 mg, Tasigna 400 mg, XS003 (nilotinib) 192mg, XS003 (nilotinib) 96mg |
| Tasigna (nilotinib)To evaluate the PK dose proportionality of Tasigna 200 mg versus Tasigna 400 mg and XS003 capsules 2x48mg (96mg) versus XS003 capsules 4x48mg (192mg). | Drug | Tasigna 200 mg, Tasigna 400 mg, XS003 (nilotinib) 192mg, XS003 (nilotinib) 96mg |
Primary outcome
Bioavailability (Peak Plasma Concentration (Cmax)) of XS003 versus Tasigna treatment
Time frame: PK samples will be collected at pre-dose (0.00) and between 0.50 and 120.00 hours post dose
To evaluate the relative bioavailability (Peak Plasma Concentration (Cmax)) of XS003 capsules 2x48mg (96mg) versus Tasigna 200 mg, and XS003 capsules 4x48mg versus Tasigna 400 mg after a single dose under fasted conditions in healthy, adult, human subjects.
Bioavailability (Area under the plasma concentration versus time curve (AUC)) of XS003 versus Tasigna treatment
Time frame: PK samples will be collected at pre-dose (0.00) and between 0.50 and 120.00 hours post dose
To evaluate the relative bioavailability (Area under the plasma concentration versus time curve (AUC)) of XS003 capsules 2x48mg (96mg) versus Tasigna 200 mg, and XS003 capsules 4x48mg versus Tasigna 400 mg after a single dose under fasted conditions in healthy, adult, human subjects.
2 secondary outcomes
Safety (adverse events (AE)) of XS003 versus Tasigna treatment
Time frame: From baseline up to 58 days
Safety (electrokardiografi ECG)) of XS003 versus Tasigna treatment
Time frame: From baseline up to 58 days
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. N/A as this is a Bioavailibility study
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
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 (nilotinib) and Tasigna (nilotinib) in people with Cancer, 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 25 inclusion and 50 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 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?
Bioavailability (Peak Plasma Concentration (Cmax)) of XS003 versus Tasigna treatment (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.