NCT07138352

Bioavailability Study of XS003 (Nilotinib)

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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Xspray Pharma AB · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Cancer

Interventions

Type	Name	Description
DRUG	XS003 under fed and fasted condition	XS003 under fed and fasted condition

Timeline

• Start date: 2024-10-03
• Primary completion: 2025-01-08
• Completion: 2025-01-08
• First posted: 2025-08-22
• Last updated: 2025-08-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study