Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Vericiguat(BAY1021189, high-dose pediatric-formulation)_fed
Vericiguat_fed · 1 trial · 1 indication
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
| Arm | Type | Description |
|---|---|---|
| Treatment A | EXPERIMENTAL | Single oral dose of 20 x 0.5 mg vericiguat high-dose pediatric formulation, fed, American breakfast |
| Treatment B | EXPERIMENTAL | Single oral dose of 20 x 0.5 mg vericiguat high-dose pediatric formulation, fasted |
| Treatment C | EXPERIMENTAL | Single oral dose of 25 x 0.1 mg vericiguat high-dose pediatric formulation, fed, American breakfast |
| Treatment D | ACTIVE_COMPARATOR | Single oral dose of 10 mg vericiguat intact IR tablet, adult formulation, fed, American breakfast |
| Treatment E | EXPERIMENTAL | Single oral dose of 10 mg vericiguat crushed IR tablet, adult formulation, fed, American breakfast |
| Treatment F | EXPERIMENTAL | Single oral dose of 10 mg vericiguat intact IR tablet, adult formulation, fed, continental breakfast |
| Name | Type | Description |
|---|---|---|
| Vericiguat(BAY1021189, high-dose pediatric-formulation)_fed | DRUG | Vericiguat high-dose pediatric formulation (fed; American breakfast), 10 mg given as 20 x 0.5 mg mini tablets |
| Vericiguat(BAY1021189, high-dose pediatric-formulation)_fasted | DRUG | Vericiguat high-dose pediatric formulation (fasted),10 mg given as 20 x 0.5 mg mini tablets |
| Vericiguat(BAY1021189, low-dose pediatric-formulation)_fed | DRUG | Vericiguat low-dose pediatric-formulation (fed; American breakfast), 2.5 mg given as 25 x 0.1 mg mini tablets |
| Vericiguat(BAY1021189,10 mg IR film-coated tablets,intact)_fed;American breakfast | DRUG | 10 mg IR tablet, intact (fed; American breakfast) |
| Vericiguat(BAY1021189,10 mg IR film-coated tablets,crushed)_fed;American breakfast | DRUG | 10 mg IR tablet, crushed (fed; American breakfast) |
| Vericiguat(BAY1021189,10 mg IR film-coated tablets,intact)_fed;Continental breakfast | DRUG | 10 mg IR tablet, intact (fed; Continental breakfast) |
Inclusion Criteria: * Healthy male subject * Age: 18 to 45 years (inclusive) at informed consent * Race: white * Body Mass Index (BMI): above or equal 18.0 and below or equal 29.9 kg / m² Exclusion Criteria: * Incompletely cured pre-existing diseases for which it can be assumed that the absorptio...