Interaction study with warfarin in healthy male subjects
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.
- 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
Mönchengladbach, Germany, 41061
E-mail: [email protected]
Phone: Not Available
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