Trial Condition(s):
Clinical Pharmacology
Drug-drug interaction study to investigate the effect of finerenone on warfarin
Bayer Identifier:
14503
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
EU CT Number:
Not Available
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.
Inclusion Criteria
- Healthy White male subjects 18-45 years of age (inclusive)
Exclusion Criteria
No Exclusion Criteria Available
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Berlin, Germany, 13353 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
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
Primary Outcome
- Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC) of R-Warfarin in Plasma After Single Dose of WarfarinTimeframe: 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 WarfarinTimeframe: 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 WarfarinTimeframe: 0 h (pre-dose) on Day 2 to 96 h post-dose
- Maximum Observed Drug Concentration of S-Warfarin in Plasma (Cmax)Timeframe: 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 WarfarinTimeframe: 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 WarfarinTimeframe: 0 hour (pre-dose of Warfarin) on Day 2 to 96 h post-dose
- Area Under the Plasma Concentration Versus Time Curve of FinerenoneTimeframe: 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 IntervalTimeframe: 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 WarfarinTimeframe: 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 WarfarinTimeframe: 0 hour (pre-dose of Warfarin) on Day 2 to 96 h post-dose
- Number of participants with adverse eventsTimeframe: From the start of study treatment up to 14 days after the last study drug administration
Additional Information
Not Available
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