Evaluating the Pharmacokinetic Parameters and Relative Bioavailability of Sorafenib (XS005) in Healthy Male Subjects

Exclusion Criteria

• •1. Subjects who have received any IMP in a clinical research study within the previous 3 months.
• •2. Subjects who are study site employees, or immediate family members of a study site or sponsor employee.
• •3. Subjects who have previously been enrolled in this study.
• •4. History of any drug or alcohol abuse in the past 2 years.
• •5. Regular alcohol consumption \>21 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 Units = 125 mL glass of wine, depending on type).
• •6. Current smokers and those who have smoked within the last 12 months. A breath carbon monoxide reading of greater than 10 ppm at screening and admission.
• •7. Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months.
• •8. Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator at screening.
• •9. Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the investigator.
• •10. Subjects has amylase or lipase result exceeding \>1.5 x upper limit of normal (ULN) at screening.
• •11. Positive drugs of abuse or alcohol breath test result.
• •12. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results.
• •13. History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder, as judged by the investigator.
• •14. Subject has a QT interval corrected by Fredericia (QTcF) \>450 ms based on ECG at screening or at pre-dose Period 1 or a history of additional risk factors for Torsades de Pointe (eg hypokalaemia, hypomagnesia, a family history of long QT syndrome).
• •15. Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients.
• •16. Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hayfever is allowed unless it is active.
• •17. Donation or loss of greater than 400 mL of blood within the previous 3 months.
• •18. Subjects who are taking, or have taken, any prescribed or over-the-counter drug (other than 4 g per day paracetamol) or herbal remedies in the 14 days before IMP administration. Exceptions may apply on a case by case basis, if considered not to interfere with the objectives of the study, as agreed by the PI and sponsor's medical monitor.
• •19. Subjects with pregnant partners.
• •20. Failure to satisfy the investigator of fitness to participate for any other reason.