Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Formulation 4 · 1 trial · 1 indication
The sensory data will be collected on an ordinale scale, with higher scores indicating greater intensity of that sensory characteristic. The scores will be analyzed to determine the taste profile of each oral suspension for the key sensory characteristics and how the taste profiles of the suspensions compare to one another.
| Arm | Type | Description |
|---|---|---|
| Intervention sequence 1 | EXPERIMENTAL | Subjects will receive 5 different formulations in sequence No. 1. The intervention administrations will be separated by a washout phase of 24 h. |
| Intervention sequence 2 | EXPERIMENTAL | Subjects will receive 5 different formulations in sequence No. 2. The intervention administrations will be separated by a washout phase of 24 h. |
| Intervention sequence 3 | EXPERIMENTAL | Subjects will receive 5 different formulations in sequence No. 3. The intervention administrations will be separated by a washout phase of 24 h. |
| Intervention sequence 4 | EXPERIMENTAL | Subjects will receive 5 different formulations in sequence No. 4. The intervention administrations will be separated by a washout phase of 24 h. |
| Intervention sequence 5 | EXPERIMENTAL | Subjects will receive 5 different formulations in sequence No. 5. The intervention administrations will be separated by a washout phase of 24 h. |
| Name | Type | Description |
|---|---|---|
| Formulation 1 | DRUG | Oral suspension of Vericiguat (BAY1021189) in single dose (SD). |
| Formulation 2 | DRUG | Oral suspension of Vericiguat (BAY1021189) with increased level of sucralose in SD. |
| Formulation 3 | DRUG | Oral suspension of Vericiguat (BAY1021189) with increased level of flavor in SD. |
| Formulation 4 | DRUG | Oral suspension of Vericiguat (BAY1021189) with increased level of sucralose and flavor in SD. |
| Formulation 5 (placebo) | DRUG | Matching placebo of formulation 1 in SD. |
Inclusion Criteria: * Participant must be 18 to 45 years of age inclusive, at the time of signing the informed consent. * Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring. * Body Mass I...
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