Effect of Neomycin on the Pharmacokinetics of Regorafenib

NCT ID: NCT02001909

Last Updated: 2015-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2014-04-30

Brief Summary

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

Conditions

Neoplasms

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

Regorafenib

Group Type: EXPERIMENTAL

Regorafenib (Stivarga, BAY73-4506)

Intervention Type: DRUG

single oral dose (s.d.) 160 mg (four 40 mg tablets) of regorafenib on two occasions (Day 1, Period 1, and Day 1, Period 2) separated by a washout period of at least 14 days

Neomycin

Group Type: EXPERIMENTAL

Neomycin

Intervention Type: DRUG

1 g tid (three times a day) regimen of Neomycin (oral) on five days in Period 2 starting 4 days before regorafenib intake on day 1 in period 2.

Interventions

Regorafenib (Stivarga, BAY73-4506)

single oral dose (s.d.) 160 mg (four 40 mg tablets) of regorafenib on two occasions (Day 1, Period 1, and Day 1, Period 2) separated by a washout period of at least 14 days

Intervention Type: DRUG

Neomycin

1 g tid (three times a day) regimen of Neomycin (oral) on five days in Period 2 starting 4 days before regorafenib intake on day 1 in period 2.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Berlin, State of Berlin, Germany

Countries

Germany

Related Links

http://www.clinicaltrialsregister.eu/

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

Other Identifiers

2013-001721-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

16675

Identifier Type: -

Identifier Source: org_study_id