Effect of Neomycin on the Pharmacokinetics of Regorafenib

Inclusion:

• Healthy male subjects
• Age: 18 to 45 years (inclusive) at the first screening examination/visit
• Body mass index (BMI): above/equal 18 and below 30 kg / m²
• Confirmation of the subject's health insurance coverage prior to the first screening examination/visit
• Subjects enrolled in this study must use adequate barrier birth control measures prior to, during the course of the study, and 3 months after the last administration of regorafenib. An adequate contraception includes the use of condoms or a vasectomy. In addition, adequate birth control measures for the subject's partner is required, such as a hormonal contraception with implants or combined oral contraceptives, certain intrauterine devices, bilateral tubal ligation, or hysterectomy.

Exclusion:

• Known or suspected hypersensitivity to regorafenib and/or neomycin
• Any illness or medical condition that is unstable or could jeopardize the safety of the subject and his compliance in the study
• Clinically significant illness within 30 days prior to Day 1, Period 1.
• Regular use of medicines at the time of screening, including herbal supplements and high dose vitamins
• Smoking; however, former smokers who have stopped smoking at least 3 months before the first study drug administration may be included
• Clinically relevant findings in the electrocardiogram (ECG)
• Clinically relevant findings in the complete physical examination
• Positive results for hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibodies (anti-HCV), human immune deficiency virus antibodies (anti-HIV 1+2) at screening.
• Positive urine drug screening