check_circleStudy Completed
Neoplasms
Bayer Identifier:
16675
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Effect of neomycin on the pharmacokinetics of regorafenib
Trial purpose
To investigate the effect of neomycin on the pharmacokinetics (PK) of regorafenib in healthy male subjects
Key Participants Requirements
Sex
MaleAge
18 - 45 YearsTrial summary
Enrollment Goal
27Trial Dates
December 2013 - April 2014Phase
Phase 1Could I Receive a placebo
NoProducts
Stivarga (Regorafenib, BAY73-4506)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Berlin, 13353, Germany |
Primary Outcome
- Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC) of Regorafenib after a single dosedate_rangeTime Frame:Period 1: 1 hour (h) predoseat Day 0; 1 (30 minute; 1, 2, 3, 4, 6, 8, 12 h), 2 (0, 12 h), 3, 4, 5, 6, 7, 8, 9, days postdose;Period 2: 1 h predose at Day 0; 1 (30 minute; 1, 2, 3, 4, 6, 8, 12 h), 2 (0, 12 h), 3, 4, 5, 6, 7, 8, 9 days postdoseenhanced_encryptionNoSafety Issue:
- Maximum Observed Drug Concentration (Cmax) of Regorafenib after a Single Dosedate_rangeTime Frame:Period 1: 1 hour (h) predoseat Day 0; 1 (30 minute; 1, 2, 3, 4, 6, 8, 12 h), 2 (0, 12 h), 3, 4, 5, 6, 7, 8, 9, days postdose;Period 2: 1 h predose at Day 0; 1 (30 minute; 1, 2, 3, 4, 6, 8, 12 h), 2 (0, 12 h), 3, 4, 5, 6, 7, 8, 9 days postdoseenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC) of Metabolites M-2(BAY75-7495)and M-5(BAY81-8752)after a Single Dosedate_rangeTime Frame:Period 1: 1 hour (h) predoseat Day 0; 1 (30 minute; 1, 2, 3, 4, 6, 8, 12 h), 2 (0, 12 h), 3, 4, 5, 6, 7, 8, 9, days postdose;Period 2: 1 h predose at Day 0; 1 (30 minute; 1, 2, 3, 4, 6, 8, 12 h), 2 (0, 12 h), 3, 4, 5, 6, 7, 8, 9 days postdoseenhanced_encryptionNoSafety Issue:
- AMaximum Observed Drug Concentration (Cmax) of Metabolites M-2(BAY75-7495)and M-5(BAY81-8752)after a Single Dosedate_rangeTime Frame:Period 1: 1 hour (h) predoseat Day 0; 1 (30 minute; 1, 2, 3, 4, 6, 8, 12 h), 2 (0, 12 h), 3, 4, 5, 6, 7, 8, 9, days postdose;Period 2: 1 h predose at Day 0; 1 (30 minute; 1, 2, 3, 4, 6, 8, 12 h), 2 (0, 12 h), 3, 4, 5, 6, 7, 8, 9 days postdoseenhanced_encryptionNoSafety Issue:
- Time to Reach Maximum Drug Concentration in Plasma (tmax) of Regorafenib and its Metabolites M-2(BAY75-7495)and M-5(BAY81-8752)after a Single Dosedate_rangeTime Frame:Period 1: 1 hour (h) predoseat Day 0; 1 (30 minute; 1, 2, 3, 4, 6, 8, 12 h), 2 (0, 12 h), 3, 4, 5, 6, 7, 8, 9, days postdose;Period 2: 1 h predose at Day 0; 1 (30 minute; 1, 2, 3, 4, 6, 8, 12 h), 2 (0, 12 h), 3, 4, 5, 6, 7, 8, 9 days postdoseenhanced_encryptionNoSafety Issue:
- Time of Last Concentration (tlast) of Regorafenib and its Metabolites M-2(BAY75-7495)and M-5(BAY81-8752)after a Single Dosedate_rangeTime Frame:Period 1: 1 hour (h) predoseat Day 0; 1 (30 minute; 1, 2, 3, 4, 6, 8, 12 h), 2 (0, 12 h), 3, 4, 5, 6, 7, 8, 9, days postdose;Period 2: 1 h predose at Day 0; 1 (30 minute; 1, 2, 3, 4, 6, 8, 12 h), 2 (0, 12 h), 3, 4, 5, 6, 7, 8, 9 days postdoseenhanced_encryptionNoSafety Issue:
- Terminal Half Life Associated With the Terminal Slope (t1/2) of Regorafenib and its Metabolites M-2(BAY75-7495)and M-5(BAY81-8752)after a Single Dosedate_rangeTime Frame:Period 1: 1 hour (h) predoseat Day 0; 1 (30 minute; 1, 2, 3, 4, 6, 8, 12 h), 2 (0, 12 h), 3, 4, 5, 6, 7, 8, 9, days postdose;Period 2: 1 h predose at Day 0; 1 (30 minute; 1, 2, 3, 4, 6, 8, 12 h), 2 (0, 12 h), 3, 4, 5, 6, 7, 8, 9 days postdoseenhanced_encryptionNoSafety Issue:
- Area Under the Concentration Versus Time Curve From Zero to 24 hours (AUC[024]) of Regorafenib and its Metabolites M-2(BAY75-7495)and M-5(BAY81-8752)after a Single Dosedate_rangeTime Frame:Period 1: 1 hour (h) predoseat Day 0; 1 (30 minute; 1, 2, 3, 4, 6, 8, 12 h), 2 (0, 12 h), 3, 4, 5, 6, 7, 8, 9, days postdose;Period 2: 1 h predose at Day 0; 1 (30 minute; 1, 2, 3, 4, 6, 8, 12 h), 2 (0, 12 h), 3, 4, 5, 6, 7, 8, 9 days postdoseenhanced_encryptionNoSafety Issue:
- Area Under the Concentration Versus Time Curve From Zero to Last Data Point (AUC[0tlast]) of Regorafenib and its Metabolites M-2(BAY75-7495)and M-5(BAY81-8752)after a Single Dosedate_rangeTime Frame:Period 1: 1 hour (h) predoseat Day 0; 1 (30 minute; 1, 2, 3, 4, 6, 8, 12 h), 2 (0, 12 h), 3, 4, 5, 6, 7, 8, 9, days postdose;Period 2: 1 h predose at Day 0; 1 (30 minute; 1, 2, 3, 4, 6, 8, 12 h), 2 (0, 12 h), 3, 4, 5, 6, 7, 8, 9 days postdoseenhanced_encryptionNoSafety Issue:
- Amount of Drug Excreted into Urine from 0 to 24 hours (AE,ur[0–24]) for Metabolites M-7 (BAY86-6651) and M-8 (BAY86-6652)date_rangeTime Frame:Urine collection interval: 0-24 hours
- Amount of Drug Excreted into Urine from 0 to 72 hours (AE,ur[0–72]) for Metabolites M-7 (BAY86-6651) and M-8 (BAY86-6652)date_rangeTime Frame:Urine collection interval: 0-72 hours
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
OtherAllocation
Non-randomizedBlinding
Open LabelAssignment
Parallel AssignmentTrial Arms
2Additional Information
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