Drug-drug interaction with aspirin
Primary objective of pilot part:
• to investigate the safety and tolerability of a single dose of 15 mg vericiguat administered as three 5 mg immediate release (IR) tablets in fasted state.
Secondary objective of pilot part:
• to investigate the pharmacokinetics of a single dose of 15 mg vericiguat administered as three 5 mg IR tablets in fasted state.
Primary objective of main part:
• to investigate the influence of a combined treatment of a single dose of 10 mg or 15 mg vericiguat (administered as two or three 5 mg IR tablets) and Aspirin on bleeding time and platelet aggregation (pharmacodynamics).
- Healthy white male subjects - 18 to 45 years (inclusive) of age - Normal body weight with a body mass index (BMI) between 18 and 30 kg/m² (both inclusive)
- Subjects with conspicuous findings in medical history and at the screening visit - Subjects with a 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 - Febrile illness within 1 week before the first drug administration - Subjects with hypersensitivity to the investigational drug, the control agent and/ or to inactive constituents - Regular use of therapeutic or recreational drugs - Use of medication within the 2 weeks preceding the study which could have interfered with the investigational product - Therapies (e.g. physiotherapy, acupuncture, etc.) within 4 weeks before starting study treatment - Regular daily consumption of more than 10 cigarettes - Regular daily consumption of more than 500 mL of usual beer or the equivalent quantity of approximately 20 g of alcohol in another form
Wuppertal, Germany, 42113
E-mail: [email protected]
Phone: Not Available
Aspirin interaction study to investigate the influence of Aspirin (2x 500 mg, 500 mg once daily) combined with a single dose of 15 mg Vericiguat (BAY 1021189) on bleeding time and platelet aggregation in comparison to a single dose of 15 mg Vericiguat (BAY 1021189) alone and to 2 single doses of Aspirin in healthy male subjects in randomized, non-blinded, non-placebo-controlled 3-fold cross-over design (main- part), preceded by a pilot part to investigate safety, tolerability and pharmacokinetics of 15 mg Vericiguat (BAY 1021189) tablet in healthy male subjects in a non-randomized, non-blinded, non-controlled design
Single Group Assignment