Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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...
Vericiguat_fed refers to a high-dose pediatric formulation of vericiguat, also known as BAY1021189, studied under fed conditions. It is a small molecule developed by Bayer AG. The formulation was evaluated in a Phase 1 trial to characterize its pharmacokinetics in adult healthy subjects.
Vericiguat_fed is developed by Bayer AG, which trades on the OTC market under the ticker BAYRY. Bayer is the sponsor of the clinical program for this high-dose pediatric formulation of vericiguat.
Vericiguat_fed is in Phase 1 clinical development. The only listed trial is a completed Phase 1 study. It is an investigational formulation and has not been approved by the FDA for any indication.
Vericiguat_fed has been studied in one completed Phase 1 trial, NCT03145038, titled "Relative Bioavailability and Food Effect Study With Vericiguat to Characterize the Pediatric Formulation in Adult Healthy Subjects." The trial enrolled 30 healthy male volunteers in Germany and used an active-controlled design.
Vericiguat_fed is a high-dose pediatric formulation of vericiguat, also known as BAY1021189. It is not a different drug but a specific formulation studied under fed conditions. The name distinguishes it from other vericiguat formulations in clinical research.