Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Vericiguat- Intervention D · 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 D is an investigational small molecule developed by Merck & Company, Inc. (MRK) for heart failure. It is a Phase 1 candidate studied in a single completed trial of 36 healthy adult male participants. It is also known as vericiguat, Verquvo, or BAY1021189.
Vericiguat- Intervention D is being studied for heart failure. The only clinical trial to date enrolled healthy adult male volunteers rather than patients, and it examined how the drug is absorbed when taken as a single liquid dose with and without food compared with a 10 mg immediate-release tablet.
Merck & Company, Inc., which trades under the ticker MRK, is the developer of Vericiguat- Intervention D. The company sponsored the Phase 1 study of the candidate conducted in Germany.
Vericiguat- Intervention D is in Phase 1 development. It is investigational and has not been approved. One Phase 1 trial has been completed, with no active trials ongoing, and that study enrolled 36 healthy adult male participants.
Vericiguat- Intervention D has been studied in one completed Phase 1 trial, NCT05086952. Titled a study in healthy adult male participants, it evaluated how vericiguat is absorbed with and without food when given as a single liquid dose suitable for children compared with a 10 mg immediate-release tablet. It enrolled 36 participants in Germany.
Yes. Vericiguat- Intervention D is also known as vericiguat, Verquvo, and BAY1021189. These names refer to the same small molecule being developed by Merck & Company, Inc. (MRK) for heart failure.