check_circleStudy Completed
Clinical Pharmacology
Bayer Identifier:
14503
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
EU CT Number:
Not Available
Drug-drug interaction study to investigate the effect of finerenone on warfarin
Trial purpose
The primary objective of this study was to investigate whether, with respect to warfarin, there is any pharmacodynamic or pharmacokinetic interaction when finerenone and warfarin are co-administered in healthy subjects.
The secondary objectives were the investigation of the pharmacokinetics of finerenone alone and after concomitant administration with warfarin, as well as the assessment of safety and tolerability of these treatments.
The secondary objectives were the investigation of the pharmacokinetics of finerenone alone and after concomitant administration with warfarin, as well as the assessment of safety and tolerability of these treatments.
Key Participants Requirements
Sex
MaleAge
18 - 45 YearsTrial summary
Enrollment Goal
32Trial Dates
October 2014 - June 2015Phase
Phase 1Could I Receive a placebo
YesProducts
Kerendia (Finerenone, BAY94-8862)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 R-Warfarin in Plasma After Single Dose of Warfarindate_rangeTime Frame:0 hour (h) (pre-dose) on Day 2 to 96 h post-dose
- Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC) of S-Warfarin in Plasma After Single Dose of Warfarindate_rangeTime Frame:0 h (pre-dose) on Day 2 to 96 h post-dose
- Maximum Observed Drug Concentration of R-Warfarin in Plasma (Cmax) After Single Dose of Warfarindate_rangeTime Frame:0 h (pre-dose) on Day 2 to 96 h post-dose
- Maximum Observed Drug Concentration of S-Warfarin in Plasma (Cmax)date_rangeTime Frame:0 h (pre-dose) on Day 2 to 96 h post-dose
- Area Under the Concentration Versus Time Curve From Zero to 96 hours [AUC (0-96)] of Prothrombin Time in Plasma After Single Dose of Warfarindate_rangeTime Frame:0 hour (pre-dose of Warfarin) on Day 2 to 96 h post-dose
- Area Under the Concentration Versus Time Curve From Zero to 96 hours [AUC (0-96)] of Clotting Factor VII activity in Plasma After Single Dose of Warfarindate_rangeTime Frame:0 hour (pre-dose of Warfarin) on Day 2 to 96 h post-dose
- Area Under the Plasma Concentration Versus Time Curve of Finerenonedate_rangeTime Frame:Finerenone 20 mg with warfarin: 0 h (pre-dose of Warfarin and Finerenone) on Day 2 to 24 h post-dose of Warfarin and Finerenone; Finerenone 20 mg: 0 h (pre-dose of Finerenone) on Day 1 to 24 hours postdose of Finerenone
- Maximum Observed Drug Concentration of Finerenone in Plasma After Multiple Dose Administration (Cmax,md) During a Dosage Intervaldate_rangeTime Frame:Finerenone 20 mg with warfarin: 0 h (pre-dose of Warfarin and Finerenone) on Day 2 to 24 h post-dose of Warfarin and Finerenone; Finerenone 20 mg: 0 h (pre-dose of Finerenone) on Day 1 to 24 hours postdose of Finerenone
Secondary Outcome
- Area Under the Concentration Versus Time Curve From Zero to 96 hours [AUC (0-96)] of Clotting Factor II in Plasma After Single Dose of Warfarindate_rangeTime Frame:0 hour (pre-dose of Warfarin) on Day 2 to 96 h post-dose
- Area Under the Concentration Versus Time Curve From Zero to 96 hours [AUC (0-96)] of Clotting Factor X in Plasma After Single Dose of Warfarindate_rangeTime Frame:0 hour (pre-dose of Warfarin) on Day 2 to 96 h post-dose
- Number of participants with adverse eventsdate_rangeTime Frame:From the start of study treatment up to 14 days after the last study drug administration
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
OtherAllocation
RandomizedBlinding
N/AAssignment
Crossover AssignmentTrial Arms
2