Trial record 8 of 92 for:    regorafenib

Effect of Neomycin on the Pharmacokinetics of Regorafenib

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT02001909
First received: November 28, 2013
Last updated: March 31, 2015
Last verified: March 2015
  Purpose

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


Condition Intervention Phase
Neoplasms
Drug: Regorafenib (Stivarga, BAY73-4506)
Drug: Neomycin
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • AUC (area under the plasma concentration vs. time curve) for regorafenib [ Time Frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 and 192 hours post-dose ] [ Designated as safety issue: No ]
  • Cmax (maximum drug concentration) for regorafenib [ Time Frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 and 192 hours post-dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • AUC(0-24) (area under the plasma concentration vs. time curve) for regorafenib [ Time Frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose ] [ Designated as safety issue: No ]
  • AUC(0-tlast) (area under the plasma concentration vs. time curve) for regorafenib [ Time Frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 and 192 hours post-dose ] [ Designated as safety issue: No ]
  • AUC (area under the plasma concentration vs. time curve) for BAY75-7495 (M-2) and BAY81-8752 (M-5) [ Time Frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 and 192 hours post-dose ] [ Designated as safety issue: No ]
  • Cmax (maximum drug concentration) for M-2 and M-5 [ Time Frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 and 192 hours post-dose ] [ Designated as safety issue: No ]
  • tmax (time to reach maximum drug concentration in plasma after single dose) for regorafenib, M-2 and M-5 [ Time Frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 and 192 hours post-dose ] [ Designated as safety issue: No ]
  • tlast (time of last concentration above lower limit of quantification) for regorafenib, M-2 and M-5 [ Time Frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 and 192 hours post-dose ] [ Designated as safety issue: No ]
  • t1/2 (half-life associated with the terminal slope) for regorafenib, M-2 and M-5 [ Time Frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 and 192 hours post-dose ] [ Designated as safety issue: No ]
  • 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) [ Time Frame: 0-72 hours post dose ] [ Designated as safety issue: No ]
  • Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: Up to 30 days after last dose ] [ Designated as safety issue: Yes ]

Enrollment: 27
Study Start Date: December 2013
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Regorafenib Drug: 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
Experimental: Neomycin 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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02001909

Locations
Germany
Berlin, Germany, 13353
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02001909     History of Changes
Other Study ID Numbers: 16675, 2013-001721-18
Study First Received: November 28, 2013
Last Updated: March 31, 2015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:
Regorafenib
Neomycin
Cancer
Pharmacokinetics
Safety

Additional relevant MeSH terms:
Neomycin
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Synthesis Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on July 01, 2015