A Bioavailability Study of Nilotinib in Healthy, Adult, Human Subjects Under Fasted Conditions.

NCT07138378 | Completed Phase 1

• 1 other identifier: XS003-11
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Cancer

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  From baseline up to 58 days

• Safety (electrokardiografi ECG)) of XS003 versus Tasigna treatment

  From baseline up to 58 days

Study Arms (4)

Tasigna 200 mg

ACTIVE COMPARATOR

A single oral dose of Treatment Tasigna 200 mg

Drug: XS003 (nilotinib); Drug: Tasigna (nilotinib)

Tasigna 400 mg

ACTIVE COMPARATOR

A single oral dose of Treatment Tasigna 400 mg

Drug: XS003 (nilotinib); Drug: Tasigna (nilotinib)

XS003 (nilotinib) 96mg

EXPERIMENTAL

A single oral dose of Treatment XS003 Capsules 2x48mg (96mg)

Drug: XS003 (nilotinib); Drug: Tasigna (nilotinib)

XS003 (nilotinib) 192mg

EXPERIMENTAL

A single oral dose of Treatment XS003 Capsules 4x48mg (192mg)

Drug: XS003 (nilotinib); Drug: Tasigna (nilotinib)

Interventions

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 200 mg; Tasigna 400 mg; XS003 (nilotinib) 192mg; XS003 (nilotinib) 96mg

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).

Tasigna 200 mg; Tasigna 400 mg; XS003 (nilotinib) 192mg; XS003 (nilotinib) 96mg

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• 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
• 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

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 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.
• 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

Sponsors & Collaborators

• Xspray Pharma AB: lead

Study Sites (1)

QPS Bioserve India Pvt Limited

Hyderabad, 500037, India

Location

MeSH Terms

Conditions

Neoplasms

Interventions

nilotinib

Study Officials

• Maria Klockare

  Xspray Pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open label study. The bioanalytical personnel will be blinded to the randomization schedule until bioanalysis completed
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 22, 2025
• Study Start: November 15, 2024
• Primary Completion: December 15, 2024
• Study Completion: December 15, 2024
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)