check_circleStudy Completed

Clinical pharmacology

Bayer Identifier:

15839

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2014-004880-19

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.

Key Participants Requirements

Sex

Male

Age

18 - 55 Years
  • - Healthy male subject
    - Age: 18 to 55 years (inclusive) at the first screening examination / visit
    -Race: White
    - Body mass index (BMI): above / equal 18.0 and below / equal 30.0 kg/m²

  • - Incompletely cured pre-existing diseases for which it could be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs was not normal.
    - Medical disorder, condition, or history of such that would have impaired the subject’s ability to participate or complete this study in the opinion of the investigator or the sponsor.
    - Symptomatic postural hypotension (e.g. dizziness, lightheadedness).
    - Known hypersensitivity to the study drugs (active substances or excipients of the preparations).
    - Known severe allergies, non-allergic drug reactions, or multiple drug allergies.
    - Febrile illness within 1 week before the first study drug administration.
    - Hemorrhagic tendencies or blood dyscrasias
    - Recent or contemplated surgery of the central nervous system or eye, or traumatic surgery resulting in large open surfaces
    - Bleeding tendencies associated with:
     -- Active ulceration or overt bleeding of the gastrointestinal, genitourinary, or respiratory tract
     -- Central nervous system hemorrhage
     -- Cerebral aneurysms, dissecting aorta
     -- Pericarditis and pericardial effusions
     -- Bacterial endocarditis

Trial summary

Enrollment Goal
29
Trial Dates
March 2015 - May 2016
Phase
Phase 1
Could I Receive a placebo
Yes
Products
Verquvo (Vericiguat, BAY1021189)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
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 Warfarin
    date_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 Warfarin
    date_rangeTime Frame:
    0 h (pre-dose) to 120 h post-dose
  • Maximum Observed Concentration (Cmax) of R-Warfarin in Plasma After Single Dose of Warfarin
    date_rangeTime Frame:
    0 h (pre-dose) to 120 h post-dose
  • Maximum Observed Concentration (Cmax) of S-Warfarin in Plasma After Single Dose of Warfarin
    date_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 Warfarin
    date_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 Warfarin
    date_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 Vericiguat
    date_rangeTime Frame:
    0 h (pre-dose) to 24 h post-dose
  • Maximum Observed Drug Concentration in Plasma After Multiple Dose Administration (Cmax,md) of Vericiguat
    date_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 Warfarin
    date_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 Warfarin
    date_rangeTime Frame:
    0 h (pre-dose) to 96 h post-dose

Trial design

Randomized, double-blind, placebo-controlled, 2-fold cross-over study to investigate the effects of vericiguat, administered as 10 mg IR tablets OD over 9 days, on the safety, tolerability, pharmacodynamics and pharmacokinetics of warfarin in healthy subjects
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Basic Science
Allocation
Randomized
Blinding
N/A
Assignment
N/A
Trial Arms
2