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
Summary
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 regorafenibCmax (maximum drug concentration) for regorafenib
Secondary outcome: AUC(0-24) (area under the plasma concentration vs. time curve) for regorafenibAUC(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
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Male.
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
Locations and Contacts
Berlin 13353, Germany
Additional Information
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Starting date: December 2013
Last updated: August 12, 2015
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