Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Vericiguat- Intervention A · 1 trial · 2 indications
AUC: area under the concentration vs. time curve from zero to infinity after single (first) dose, calculated up by linear trapezoidal rule, down by logarithmic trapezoidal rule
AUC(0-tlast): AUC from time 0 to the last data point \> lower limit of quantitation (LLOQ)
Cmax: maximum observed drug concentration in measured matrix after single dose administration
| Arm | Type | Description |
|---|---|---|
| B-A-D-C | EXPERIMENTAL | 4-fold crossover design with 4 interventions, 4 intervention periods, and 4 intervention sequences. (according to Williams design \[balanced for 1-period-carry-over\]). |
| C-D-A-B | EXPERIMENTAL | 4-fold crossover design with 4 interventions, 4 intervention periods, and 4 intervention sequences. (according to Williams design \[balanced for 1-period-carry-over\]). |
| D-B-C-A | EXPERIMENTAL | 4-fold crossover design with 4 interventions, 4 intervention periods, and 4 intervention sequences. (according to Williams design \[balanced for 1-period-carry-over\]). |
| A-C-B-D | EXPERIMENTAL | 4-fold crossover design with 4 interventions, 4 intervention periods, and 4 intervention sequences. (according to Williams design \[balanced for 1-period-carry-over\]). |
| Name | Type | Description |
|---|---|---|
| Vericiguat (BAY1021189) - Intervention A | DRUG | Single dose of 10 mg vericiguat high-concentration pediatric formulation (oral liquid formulation) in fed state. |
| Vericiguat (BAY1021189) - Intervention B | DRUG | Single dose of 10 mg vericiguat high-concentration pediatric formulation (oral liquid formulation) in fasted state. |
| Vericiguat (BAY1021189) - Intervention C | DRUG | Single dose of 2.5 mg vericiguat low-concentration pediatric formulation (oral liquid formulation) in fed state. |
| Vericiguat (Verquvo, BAY1021189) - Intervention D | DRUG | Single dose of 10 mg vericiguat immediate release (IR) intact tablet in fed state. |
Inclusion Criteria: * Healthy male subjects * Age 18 -45 years * Body Mass Index (BMI): above or equal 18.5 and below or equal 29.9 kg / m² Exclusion Criteria: * Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and eff...
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Vericiguat- Intervention A is an investigational small molecule being studied for heart failure. It is currently in Phase 1 clinical development. The drug is being evaluated for use in adults and potentially in children with heart failure, as part of a study involving healthy adult male participants.
Vericiguat- Intervention A is being developed by Merck & Company, Inc., which trades under the ticker MRK. The company is conducting clinical trials to evaluate the drug's absorption and pharmacokinetics in healthy volunteers as part of its development program for heart failure.
Vericiguat- Intervention A is in Phase 1 clinical development. One Phase 1 trial has been completed, with no active trials currently ongoing. The drug remains investigational and has not been approved for any use.
Vericiguat- Intervention A has one completed clinical trial, NCT05086952. This Phase 1 study evaluated how the drug is absorbed with and without food when given as a liquid formulation suitable for children, compared to a 10 mg immediate-release tablet, in healthy adult male participants in Germany.
Vericiguat- Intervention A is a formulation of vericiguat, a small molecule being studied for heart failure. The trial NCT05086952 compares a liquid form of vericiguat suitable for children to a 10 mg tablet that releases the active substance immediately, indicating the drug is being developed in multiple formulations.