Effect of Neomycin on the Pharmacokinetics of Regorafenib

• Status: Completed
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: Male

Summary

To investigate the effect of neomycin on the pharmacokinetics (PK) of regorafenib in healthy male subjects

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bayer
• Treatments: Neomycin

Criteria

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