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Effect of Neomycin on the Pharmacokinetics of Regorafenib

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Neoplasms

Intervention: Regorafenib (Stivarga, BAY73-4506) (Drug); Neomycin (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer


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

Clinical Details

Official title: Single-center, Open-label, Non-randomized, Two-period Sequential Treatment Study to Assess the Effect of Neomycin on the Pharmacokinetics of Regorafenib in Healthy Male Subjects

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Primary outcome:

AUC (area under the plasma concentration vs. time curve) for regorafenib

Cmax (maximum drug concentration) for regorafenib

Secondary outcome:

AUC(0-24) (area under the plasma concentration vs. time curve) for regorafenib

AUC(0-tlast) (area under the plasma concentration vs. time curve) for regorafenib

AUC (area under the plasma concentration vs. time curve) for BAY75-7495 (M-2) and BAY81-8752 (M-5)

Cmax (maximum drug concentration) for M-2 and M-5

tmax (time to reach maximum drug concentration in plasma after single dose) for regorafenib, M-2 and M-5

tlast (time of last concentration above lower limit of quantification) for regorafenib, M-2 and M-5

t1/2 (half-life associated with the terminal slope) for regorafenib, M-2 and M-5

AE,ur(0-72) (amount of drug excreted via urine during the collection interval 0-72 hours post administration) for metabolites BAY86-6651 (M-7) and BAY86-6652 (M-8)

Number of participants with adverse events as a measure of safety and tolerability


Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Male.



- 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


- 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

Locations and Contacts

Berlin 13353, Germany
Additional Information

Click here and search for drug information provided by the FDA.

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.

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Click here to find information about studies related to Bayer Healthcare products conducted in Europe

Starting date: December 2013
Last updated: August 12, 2015

Page last updated: August 23, 2015

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