check_circleStudy Completed

Clinical Pharmacology

Bayer Identifier:

14503

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2014-001832-13

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.

Key Participants Requirements

Sex

Male

Age

18 - 45 Years
  • - Healthy White male subjects 18-45 years of age (inclusive)

  • -

Trial summary

Enrollment Goal
32
Trial Dates
October 2014 - June 2015
Phase
Phase 1
Could I Receive a placebo
Yes
Products
Kerendia (Finerenone, BAY94-8862)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
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 Warfarin
    date_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 Warfarin
    date_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 Warfarin
    date_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 Warfarin
    date_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 Warfarin
    date_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 Finerenone
    date_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 Interval
    date_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 Warfarin
    date_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 Warfarin
    date_rangeTime Frame:
    0 hour (pre-dose of Warfarin) on Day 2 to 96 h post-dose
  • Number of participants with adverse events
    date_rangeTime Frame:
    From the start of study treatment up to 14 days after the last study drug administration

Trial design

Randomized, double-blind, placebo-controlled, 2-fold cross-over study to investigate the effects of finerenone, administered as 20 mg IR tablets once-daily over 6 days, on the safety, tolerability, pharmacodynamics and pharmacokinetics of warfarin in healthy male subjects
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
Randomized
Blinding
N/A
Assignment
Crossover Assignment
Trial Arms
2