Bioavailability Study of XS003 (Nilotinib)

NCT07138352 | Completed Phase 1 FDA Drug

• 1 other identifier: XS003-14
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cancer

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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.

  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.

  From Screening until end of study, i.e. up to 56days

Study Arms (2)

XS003 fasted condition

EXPERIMENTAL

XS003 (nilotinib) Capsules 192 mg (4X 48 mg) under fasted conditions.

Drug: XS003 under fed and fasted condition

XS003 fed condition

EXPERIMENTAL

XS003 (nilotinib) Capsules 192 mg (4X 48 mg) under fed conditions

Drug: XS003 under fed and fasted condition

Interventions

XS003 under fed and fasted condition DRUG

XS003 under fed and fasted condition

XS003 fasted condition; XS003 fed condition

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

Sponsors & Collaborators

• Xspray Pharma AB: lead

Study Sites (1)

QPS Missouri

Springfield, Missouri, 65802, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Maria Klockare

  Xspray Pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: N/A as it is an open label study
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 22, 2025
• Study Start: October 3, 2024
• Primary Completion: January 8, 2025
• Study Completion: January 8, 2025
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)