Pharmacokinetic Comparison of XS003 and Tasigna

A Comparative, Proof of Concept Study, Comprising of a Pilot Phase Bioavailability Study Part and a Randomised, Cross-over Food-effect Study Part of "XS003" and Originator in Healthy Male Subjects

The study will assess bioavailability of XS003 given as a single oral dose compared to Tasigna® given as a single oral dose in healthy male subjects.

The study consists of two parts, the first part is composed as a pilot part and compares the bioavailability of single oral doses of XS003 compared to Tasigna® given as single oral dose in healthy male subjects. The second part is a food-effect part which assesses the food effect of a single oral dose of XS003 in healthy male subjects either fed or fasted. The study will also evaluate safety and tolerability of XS003 as secondary objectives.

Inclusion Criteria:

• Healthy males
• Age 18 to 55 years of age
• Body mass index (BMI) of 18.0 to 29.0 kg/m2
• Laboratory parameters in normal range

Exclusion Criteria:

• Females
• Current smokers and those who have smoked within the last 12 months. A breath carbon monoxide reading of greater than 10 ppm at screening.
• Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients.
• History of cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease as judged by the investigator.
• Subject has a QTcF>450 ms based on ECG at screening or a history of additional risk factors for Torsades de Pointe (e.g. hypokalaemia, hypomagnesemia, a family history of long QT syndrome)