Effect of Neomycin on the Pharmacokinetics of Regorafenib

Bayer

Status and phase

Completed

Phase 1

Conditions

Neoplasms

Treatments

Drug: Regorafenib (Stivarga, BAY73-4506)

Drug: Neomycin

Study type

Interventional

Funder types

Industry

Identifiers

16675

2013-001721-18 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment

27 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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