Trial Condition(s):
Clinical Pharmacology
Interaction study with warfarin in healthy male subjects
Bayer Identifier:
15839
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
EU CT Number:
Not Available
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.
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Mönchengladbach, Germany, 41061 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
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
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) 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 WarfarinTimeframe: 0 h (pre-dose) to 120 h post-dose
- Maximum Observed Concentration (Cmax) of R-Warfarin in Plasma After Single Dose of WarfarinTimeframe: 0 h (pre-dose) to 120 h post-dose
- Maximum Observed Concentration (Cmax) of S-Warfarin in Plasma After Single Dose of WarfarinTimeframe: 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 WarfarinTimeframe: 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 WarfarinTimeframe: 0 h (pre-dose) to 96 h post-dose
- Area Under the Plasma Concentration Versus Time Curve After Multiple Dose Administration (AUCtau,md) of VericiguatTimeframe: 0 h (pre-dose) to 24 h post-dose
- Maximum Observed Drug Concentration in Plasma After Multiple Dose Administration (Cmax,md) of VericiguatTimeframe: 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 WarfarinTimeframe: 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 WarfarinTimeframe: 0 h (pre-dose) to 96 h post-dose
Additional Information
Not Available
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