Multiple Dose escalation Phase I study of BAY1021189
The primary objective of this study was to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of once daily 1.25, 5.0 and 10 mg and twice daily 5 mg of vericiguat administered orally as one or multiples of 1.25 mg IR-tablets over 7 days in 12 healthy male subjects (9 on active drug and 3 on placebo) per dose step.
- Healthy male subject - Age: 18 to 45 years (inclusive) at the first screening visit - Ethnicity: white - Body mass index (BMI): above/equal 18 and below/equal 29.9 kg/m²
- Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal - Known hypersensitivity to the study drug (active substances or excipients of the preparations) - Known severe allergies, non-allergic drug reactions, or multiple drug allergies - Relevant diseases within the last 4 weeks prior to study drug administration - Febrile illness within 1 week before study drug administration - History of postural syncopes - Regular use of medicines - Regular use of therapeutic or recreational drugs - Use of medication within 2 weeks before study drug administration which could oppose the study objectives or which might influence them
Wuppertal, Germany, 42113
E-mail: [email protected]
Phone: Not Available
Multiple dose escalation study to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BAY 1021189 after oral dosing of 1.25, 5, 10 mg OD and 5 mg BID over 7 days given as 1.25 mg or multiples of 1.25 mg IR-tablet in 12 healthy male subjects per dose step in a randomized, single-blind, placebo-controlled, group-comparison design