Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05086952 | A Study in Healthy Adult Male Participants to Learn the Way Vericiguat is Absorbed With and Without Food When Taken as a Single Dose in Liquid Form Suitable for Children Compared to a 10 Milligram (mg) Tablet That Releases the Active Substance Immediately | PHASE1 | COMPLETED | 36 | — | — | Oct 12, 2021 | Feb 15, 2022 | Feb 2, 2023 | 1 | Germany |
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...