NCT02001909

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2013

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 28, 2013

Completed
3 days until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 5, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

August 13, 2015

Status Verified

August 1, 2015

Enrollment Period

4 months

First QC Date

November 28, 2013

Last Update Submit

August 12, 2015

Conditions

Neoplasms

Keywords

RegorafenibNeomycinCancerPharmacokineticsSafety

Outcome Measures

Primary Outcomes (2)

  • AUC (area under the plasma concentration vs. time curve) for regorafenib

    Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 and 192 hours post-dose

  • Cmax (maximum drug concentration) for regorafenib

    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 Outcomes (9)

  • AUC(0-24) (area under the plasma concentration vs. time curve) for regorafenib

    Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose

  • AUC(0-tlast) (area under the plasma concentration vs. time curve) for regorafenib

    Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 and 192 hours post-dose

  • AUC (area under the plasma concentration vs. time curve) for BAY75-7495 (M-2) and BAY81-8752 (M-5)

    Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 and 192 hours post-dose

  • Cmax (maximum drug concentration) for M-2 and M-5

    Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 and 192 hours post-dose

  • tmax (time to reach maximum drug concentration in plasma after single dose) for regorafenib, M-2 and M-5

    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 more secondary outcomes

Study Arms (2)

Regorafenib

EXPERIMENTAL
Drug: Regorafenib (Stivarga, BAY73-4506)

Neomycin

EXPERIMENTAL
Drug: Neomycin

Interventions

Regorafenib (Stivarga, BAY73-4506)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

Regorafenib
NeomycinDRUG

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.

Neomycin

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Berlin, State of Berlin, 13353, Germany

Location

Related Links

MeSH Terms

Conditions

Neoplasms

Interventions

regorafenibNeomycin

Intervention Hierarchy (Ancestors)

AminoglycosidesGlycosidesCarbohydrates

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2013

First Posted

December 5, 2013

Study Start

December 1, 2013

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

August 13, 2015

Record last verified: 2015-08

Locations

DE(1)