Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Formulation 1 · 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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Formulation 1 is an investigational small molecule being developed by Bayer AG for the treatment of Heart Failure. It is currently in Phase 1 clinical development. The drug is being studied as a liquid formulation, and its safety and tolerability are being evaluated in clinical trials.
Formulation 1 is being developed by Bayer AG, a multinational pharmaceutical company. Bayer's stock is traded under the ticker symbol BAYRY on the OTC market. The company is conducting clinical trials to evaluate the drug's safety and tolerability in patients with Heart Failure.
Formulation 1 is currently in Phase 1 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The drug is being studied for the treatment of Heart Failure, and its safety and tolerability are being evaluated in early-stage clinical trials.
Formulation 1 has been studied in one clinical trial, identified as NCT06474208. This was a Phase 1 study that evaluated the taste of the drug in liquid form in healthy male participants aged 18 to 45 years. The trial was conducted in Germany and has been completed.
Formulation 1 is a liquid formulation of vericiguat, a drug being studied for the treatment of Heart Failure. The clinical trial NCT06474208 was designed to learn about the taste of vericiguat given in liquid form. The drug is being developed by Bayer AG.