check_circleStudy Completed

Neoplasms

Effect of neomycin on the pharmacokinetics of regorafenib

Trial purpose

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

Key Participants Requirements

Sex

Male

Age

18 - 45 Years
  • 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

Trial summary

Enrollment Goal
27
Trial Dates
December 2013 - April 2014
Phase
Phase 1
Could I Receive a placebo
No
Products
Stivarga (Regorafenib, BAY73-4506)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Berlin, 13353, Germany

Primary Outcome

  • Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC) of Regorafenib after a single dose
    date_rangeTime Frame:
    Period 1: 1 hour (h) predoseat Day 0; 1 (30 minute; 1, 2, 3, 4, 6, 8, 12 h), 2 (0, 12 h), 3, 4, 5, 6, 7, 8, 9, days postdose;Period 2: 1 h predose at Day 0; 1 (30 minute; 1, 2, 3, 4, 6, 8, 12 h), 2 (0, 12 h), 3, 4, 5, 6, 7, 8, 9 days postdose
    enhanced_encryption
    Safety Issue:
    No
  • Maximum Observed Drug Concentration (Cmax) of Regorafenib after a Single Dose
    date_rangeTime Frame:
    Period 1: 1 hour (h) predoseat Day 0; 1 (30 minute; 1, 2, 3, 4, 6, 8, 12 h), 2 (0, 12 h), 3, 4, 5, 6, 7, 8, 9, days postdose;Period 2: 1 h predose at Day 0; 1 (30 minute; 1, 2, 3, 4, 6, 8, 12 h), 2 (0, 12 h), 3, 4, 5, 6, 7, 8, 9 days postdose
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC) of Metabolites M-2(BAY75-7495)and M-5(BAY81-8752)after a Single Dose
    date_rangeTime Frame:
    Period 1: 1 hour (h) predoseat Day 0; 1 (30 minute; 1, 2, 3, 4, 6, 8, 12 h), 2 (0, 12 h), 3, 4, 5, 6, 7, 8, 9, days postdose;Period 2: 1 h predose at Day 0; 1 (30 minute; 1, 2, 3, 4, 6, 8, 12 h), 2 (0, 12 h), 3, 4, 5, 6, 7, 8, 9 days postdose
    enhanced_encryption
    Safety Issue:
    No
  • AMaximum Observed Drug Concentration (Cmax) of Metabolites M-2(BAY75-7495)and M-5(BAY81-8752)after a Single Dose
    date_rangeTime Frame:
    Period 1: 1 hour (h) predoseat Day 0; 1 (30 minute; 1, 2, 3, 4, 6, 8, 12 h), 2 (0, 12 h), 3, 4, 5, 6, 7, 8, 9, days postdose;Period 2: 1 h predose at Day 0; 1 (30 minute; 1, 2, 3, 4, 6, 8, 12 h), 2 (0, 12 h), 3, 4, 5, 6, 7, 8, 9 days postdose
    enhanced_encryption
    Safety Issue:
    No
  • Time to Reach Maximum Drug Concentration in Plasma (tmax) of Regorafenib and its Metabolites M-2(BAY75-7495)and M-5(BAY81-8752)after a Single Dose
    date_rangeTime Frame:
    Period 1: 1 hour (h) predoseat Day 0; 1 (30 minute; 1, 2, 3, 4, 6, 8, 12 h), 2 (0, 12 h), 3, 4, 5, 6, 7, 8, 9, days postdose;Period 2: 1 h predose at Day 0; 1 (30 minute; 1, 2, 3, 4, 6, 8, 12 h), 2 (0, 12 h), 3, 4, 5, 6, 7, 8, 9 days postdose
    enhanced_encryption
    Safety Issue:
    No
  • Time of Last Concentration (tlast) of Regorafenib and its Metabolites M-2(BAY75-7495)and M-5(BAY81-8752)after a Single Dose
    date_rangeTime Frame:
    Period 1: 1 hour (h) predoseat Day 0; 1 (30 minute; 1, 2, 3, 4, 6, 8, 12 h), 2 (0, 12 h), 3, 4, 5, 6, 7, 8, 9, days postdose;Period 2: 1 h predose at Day 0; 1 (30 minute; 1, 2, 3, 4, 6, 8, 12 h), 2 (0, 12 h), 3, 4, 5, 6, 7, 8, 9 days postdose
    enhanced_encryption
    Safety Issue:
    No
  • Terminal Half Life Associated With the Terminal Slope (t1/2) of Regorafenib and its Metabolites M-2(BAY75-7495)and M-5(BAY81-8752)after a Single Dose
    date_rangeTime Frame:
    Period 1: 1 hour (h) predoseat Day 0; 1 (30 minute; 1, 2, 3, 4, 6, 8, 12 h), 2 (0, 12 h), 3, 4, 5, 6, 7, 8, 9, days postdose;Period 2: 1 h predose at Day 0; 1 (30 minute; 1, 2, 3, 4, 6, 8, 12 h), 2 (0, 12 h), 3, 4, 5, 6, 7, 8, 9 days postdose
    enhanced_encryption
    Safety Issue:
    No
  • Area Under the Concentration Versus Time Curve From Zero to 24 hours (AUC[024]) of Regorafenib and its Metabolites M-2(BAY75-7495)and M-5(BAY81-8752)after a Single Dose
    date_rangeTime Frame:
    Period 1: 1 hour (h) predoseat Day 0; 1 (30 minute; 1, 2, 3, 4, 6, 8, 12 h), 2 (0, 12 h), 3, 4, 5, 6, 7, 8, 9, days postdose;Period 2: 1 h predose at Day 0; 1 (30 minute; 1, 2, 3, 4, 6, 8, 12 h), 2 (0, 12 h), 3, 4, 5, 6, 7, 8, 9 days postdose
    enhanced_encryption
    Safety Issue:
    No
  • Area Under the Concentration Versus Time Curve From Zero to Last Data Point (AUC[0tlast]) of Regorafenib and its Metabolites M-2(BAY75-7495)and M-5(BAY81-8752)after a Single Dose
    date_rangeTime Frame:
    Period 1: 1 hour (h) predoseat Day 0; 1 (30 minute; 1, 2, 3, 4, 6, 8, 12 h), 2 (0, 12 h), 3, 4, 5, 6, 7, 8, 9, days postdose;Period 2: 1 h predose at Day 0; 1 (30 minute; 1, 2, 3, 4, 6, 8, 12 h), 2 (0, 12 h), 3, 4, 5, 6, 7, 8, 9 days postdose
    enhanced_encryption
    Safety Issue:
    No
  • Amount of Drug Excreted into Urine from 0 to 24 hours (AE,ur[0–24]) for Metabolites M-7 (BAY86-6651) and M-8 (BAY86-6652)
    date_rangeTime Frame:
    Urine collection interval: 0-24 hours
  • Amount of Drug Excreted into Urine from 0 to 72 hours (AE,ur[0–72]) for Metabolites M-7 (BAY86-6651) and M-8 (BAY86-6652)
    date_rangeTime Frame:
    Urine collection interval: 0-72 hours

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
Non-randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
2