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Effect of Neomycin on the Pharmacokinetics of Regorafenib

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ClinicalTrials.gov Identifier: NCT02001909
Recruitment Status : Completed
First Posted : December 5, 2013
Last Update Posted : August 13, 2015
Sponsor:
Information provided by (Responsible Party):
Bayer

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

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : December 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. 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 ]
  8. 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 ]
  9. Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: Up to 30 days after last dose ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02001909


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

Additional Information:
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02001909     History of Changes
Other Study ID Numbers: 16675
2013-001721-18 ( EudraCT Number )
First Posted: December 5, 2013    Key Record Dates
Last Update Posted: August 13, 2015
Last Verified: August 2015

Keywords provided by Bayer:
Regorafenib
Neomycin
Cancer
Pharmacokinetics
Safety

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