Effect of Neomycin on the Pharmacokinetics of Regorafenib

Phase 1

Completed

• Conditions: Neoplasms
• Interventions: Drug: Regorafenib (Stivarga, BAY73-4506); Drug: Neomycin

• Registration Number: NCT02001909
• Lead Sponsor: Bayer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-11-28
• Study First Submitted QC: 2013-11-28
• Study Start: 2013-12
• Study First Posted: 2013-12-05
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-12
• Last Update Posted: 2015-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 27

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Regorafenib	Regorafenib (Stivarga, BAY73-4506)	-
Neomycin	Neomycin	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
tlast (time of last concentration above lower limit of quantification) 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
t1/2 (half-life associated with the terminal slope) 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
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)	0-72 hours post dose
Number of participants with adverse events as a measure of safety and tolerability	Up to 30 days after last dose