Effect of Neomycin on the Pharmacokinetics of Regorafenib

PHASE1CompletedINTERVENTIONAL
Enrollment

27

Participants

Timeline

Start Date

December 31, 2013

Primary Completion Date

April 30, 2014

Study Completion Date

April 30, 2014

Conditions
Neoplasms
Interventions
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

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.

Trial Locations (1)

13353

Berlin

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY