check_circleStudy Completed
Clinical pharmacology
Bayer Identifier:
15839
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
EU CT Number:
Not Available
Interaction study with warfarin in healthy male subjects
Trial purpose
The primary objective of this study was to investigate the influence of multiple doses of 10 mg vericiguat once daily on the pharmacokinetics (R- and S-warfarin) and pharmacodynamics (clotting parameters) of a single oral dose of 25 mg warfarin, administered on the sixth day of treatment.
The secondary objective of this study was to assess the influence of multiple doses of 10 mg vericiguat once daily on the safety and tolerability of a single oral dose of warfarin.
The secondary objective of this study was to assess the influence of multiple doses of 10 mg vericiguat once daily on the safety and tolerability of a single oral dose of warfarin.
Key Participants Requirements
Sex
MaleAge
18 - 55 YearsTrial summary
Enrollment Goal
29Trial Dates
March 2015 - May 2016Phase
Phase 1Could I Receive a placebo
YesProducts
Verquvo (Vericiguat, BAY1021189)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Mönchengladbach, 41061, 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) to 120 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) to 120 h post-dose
- Maximum Observed Concentration (Cmax) of R-Warfarin in Plasma After Single Dose of Warfarindate_rangeTime Frame:0 h (pre-dose) to 120 h post-dose
- Maximum Observed Concentration (Cmax) of S-Warfarin in Plasma After Single Dose of Warfarindate_rangeTime Frame:0 h (pre-dose) to 120 h post-dose
- Area Under the Concentration Versus Time Curve From 0 hours (pre-dose) to 96 hours post-dose [AUC (0-96)] of Prothrombin Time (PT) in Plasma After Single Dose of Warfarindate_rangeTime Frame:0 h (pre-dose) to 96 h post-dose
- Area Under the Concentration Versus Time Curve From 0 hours (pre-dose) to 96 hours post-dose [AUC (0-96)] of Clotting Factor Seven (VII) Activity in Plasma After Single Dose of Warfarindate_rangeTime Frame:0 h (pre-dose) to 96 h post-dose
- Area Under the Plasma Concentration Versus Time Curve After Multiple Dose Administration (AUCtau,md) of Vericiguatdate_rangeTime Frame:0 h (pre-dose) to 24 h post-dose
- Maximum Observed Drug Concentration in Plasma After Multiple Dose Administration (Cmax,md) of Vericiguatdate_rangeTime Frame:0 h (pre-dose) to 24 h post-dose
Secondary Outcome
- Area Under the Concentration Versus Time Curve From 0 hours (predose) to 96 hours post-dose [AUC (0-96)] of Clotting Factor Two (II) in Plasma After Single Dose of Warfarindate_rangeTime Frame:0 h (pre-dose) to 96 h post-dose
- Area Under the Concentration Versus Time Curve From 0 hours (predose) to 96 hours post-dose [AUC (0-96)] of Clotting Factor Ten (X) in Plasma After Single Dose of Warfarindate_rangeTime Frame:0 h (pre-dose) to 96 h post-dose
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
Basic ScienceAllocation
RandomizedBlinding
N/AAssignment
N/ATrial Arms
2