check_circleStudy Completed
Neoplasms
Bayer Identifier:
15022
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Roniciclib Mass Balance Study
Trial purpose
The purpose of this trial is to investigate the fate of the roniciclib (study drug) in the body in a so called mass-balance study. This means to investigate how the study drug is absorbed, distributed, broken down (metabolized) and removed (excreted or eliminated) from the body.
Key Participants Requirements
Sex
BothAge
18 - 99 YearsTrial summary
Enrollment Goal
7Trial Dates
April 2015 - June 2016Phase
Phase 1Could I Receive a placebo
NoProducts
Roniciclib (BAY1000394)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | PRA Magyarorszag Kft. Fazis I-es Klin.Farmakol. Vizsgalohely | Budapest, 1077, Hungary |
Primary Outcome
- Amount of Roniciclib in urine as percentage of the dose of total radioactivity.date_rangeTime Frame:Up to 336 hoursenhanced_encryptionNoSafety Issue:
- Amount of Roniciclib in feces as percentage of the dose of total radioactivity.date_rangeTime Frame:Up to 336 hoursenhanced_encryptionNoSafety Issue:
- Amount of Roniciclib in vomit as percentage of the dose of total radioactivitydate_rangeTime Frame:Up to 336 hoursenhanced_encryptionNoSafety Issue:
- Cmaxof roniciclib in plasmadate_rangeTime Frame:up to 336 hoursenhanced_encryptionNoSafety Issue:
- AUC(0-tlast) of roniciclib in plasmadate_rangeTime Frame:up to 336 hoursenhanced_encryptionNoSafety Issue:
- AUC of roniciclib in plasmadate_rangeTime Frame:up to 336 hoursenhanced_encryptionNoSafety Issue:
- Cmax of total radioactivity in whole blood and plasmadate_rangeTime Frame:up to 336 hoursenhanced_encryptionNoSafety Issue:
- AUC(0-tlast) of total radioactivity in whole blood and plasmadate_rangeTime Frame:Up to 336 hoursenhanced_encryptionNoSafety Issue:
- AUC of total radioactivity in whole blood and plasmadate_rangeTime Frame:up to 336 hoursenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
Non-randomizedBlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
2