Bioavailability Study of XS003 (Nilotinib)

Completed · Phase 1

Conditions studied: Cancer

In brief

An open label, single-center, randomized, two-treatment, two-period, two-sequence, single dose, crossover, study under fasted and fed conditions.

Key facts

Study ID

NCT07138352

Run by

Xspray Pharma AB

People needed

48

Starts

2024-10-03

Expected to finish

2025-01-08

Last updated by the study team

2025-08-22

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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:
• 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.

You may not qualify if…

• 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.
• 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).

Where it is running

• QPS Missouri — Springfield, Missouri, United States

Full record on ClinicalTrials.gov

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