Neoplasms

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