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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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Formulation 4 is an investigational liquid formulation of vericiguat being developed by Bayer AG for heart failure. It is a small molecule therapy in Phase 1 clinical development. The formulation is designed to be given in liquid form, and the completed Phase 1 study evaluated its taste in healthy male participants.
Formulation 4 is being developed for heart failure, a cardiovascular condition. The only clinical study of this formulation to date enrolled healthy male volunteers rather than patients with heart failure, and it assessed the taste of the liquid form. It has not been approved for any use and remains investigational.
Formulation 4 is developed by Bayer AG, which trades under the ticker BAYRY. Bayer is the sponsor of the Phase 1 study of this liquid formulation of vericiguat. The program sits within the cardiovascular therapeutic area and focuses on heart failure as its target indication.
Formulation 4 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no trials are currently active. The study enrolled 19 healthy male participants in Germany. The drug is investigational and has not been approved by the FDA or any other regulatory authority.
Formulation 4 has been studied in one completed Phase 1 trial, NCT06474208, titled a study to learn about the taste of vericiguat given in liquid form in healthy male participants aged 18 to 45 years. It was a controlled, randomized trial with 19 participants, conducted in Germany, and it is no longer active.
Formulation 4 is a liquid formulation of vericiguat, so it contains the same active drug rather than being a distinct molecule. The Phase 1 study NCT06474208 evaluated vericiguat given in liquid form. Vericiguat itself is an approved heart failure therapy, while this specific liquid formulation remains investigational.