Single oral dose of 20 x 0.5 mg vericiguat high-dose pediatric formulation, fed, American breakfast

Single oral dose of 20 x 0.5 mg vericiguat high-dose pediatric formulation, fasted

Single oral dose of 25 x 0.1 mg vericiguat high-dose pediatric formulation, fed, American breakfast

Single oral dose of 10 mg vericiguat intact IR tablet, adult formulation, fed, American breakfast

Single oral dose of 10 mg vericiguat crushed IR tablet, adult formulation, fed, American breakfast

Vericiguat high-dose pediatric formulation (fed; American breakfast), 10 mg given as 20 x 0.5 mg mini tablets

AUC is the area under the curve (mathematically known as definite integral) in a plot of concentration of vericiguat after single dose administration in blood plasma against time (pre-dose until 72 hours after administration). AUC from time 0 to the last data point greater than lower limit of quantification divided by dose (AUC(0-tlast)/D) will be used as primary parameter if AUC cannot be calculated for all profiles, or mean AUC from the last data point to infinity [AUC(tlast-∞)] >20% of AUC. AUC will be analyzed by means of descriptive statistics.

Cmax is the maximum observed vericiguat concentration in measured plasma after single dose administration (pre-dose until 72 hours after administration). Cmax/D is the maximum observed drug concentration in measured matrix after single dose administration divided by dose.Cmax will be analyzed by means of descriptive statistics

As a secondary objective of this study the numbers of AEs will be used to assess safety and tolerability of vericiguat.

In a clinical study, an AE is any untoward medical occurrence (i.e. any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a patient or clinical investigation subject after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.

Individual listings of AEs will be provided. The incidence of treatment-emergent AEs an drug-related AEs, respectively, will be summarized by treatment using MedDRA terms (highly specific standardised medical terminology).