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Formulation 1

Phase 1

Heart Failure | Small molecule | Cardiovascular |Bayer AG|Last Updated: Oct 8, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment19

FDA Designations

No designations recorded

Clinical trial landscape

Formulation 1 · 1 trial · 1 indication

Phase 1 1
NCT06474208A Study to Learn About the Taste of Vericiguat Given in Liquid Form in Healthy Male Participants Aged 18 to 45 YearsHeart Failure
COMPLETED19 Analytics
PHASE1COMPLETED
A Study to Learn About the Taste of Vericiguat Given in Liquid Form in Healthy Male Participants Aged 18 to 45 Years
Heart FailureUnlock trial analytics

Study Endpoints

Primary Endpoints

Taste questionnaire by means of descriptive statistics
Directly after study intervention administration

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.

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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
Intervention sequence 1EXPERIMENTALSubjects will receive 5 different formulations in sequence No. 1. The intervention administrations will be separated by a washout phase of 24 h.
Intervention sequence 2EXPERIMENTALSubjects will receive 5 different formulations in sequence No. 2. The intervention administrations will be separated by a washout phase of 24 h.
Intervention sequence 3EXPERIMENTALSubjects will receive 5 different formulations in sequence No. 3. The intervention administrations will be separated by a washout phase of 24 h.
Intervention sequence 4EXPERIMENTALSubjects will receive 5 different formulations in sequence No. 4. The intervention administrations will be separated by a washout phase of 24 h.
Intervention sequence 5EXPERIMENTALSubjects will receive 5 different formulations in sequence No. 5. The intervention administrations will be separated by a washout phase of 24 h.

Interventions

NameTypeDescription
Formulation 1DRUGOral suspension of Vericiguat (BAY1021189) in single dose (SD).
Formulation 2DRUGOral suspension of Vericiguat (BAY1021189) with increased level of sucralose in SD.
Formulation 3DRUGOral suspension of Vericiguat (BAY1021189) with increased level of flavor in SD.
Formulation 4DRUGOral suspension of Vericiguat (BAY1021189) with increased level of sucralose and flavor in SD.
Formulation 5 (placebo)DRUGMatching placebo of formulation 1 in SD.
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Eligibility Criteria

Age Range18 Years to 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

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...

Countries:Germany
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Frequently asked questions about Formulation 1

What is Formulation 1 used for in Heart Failure?

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.

Who makes Formulation 1?

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.

What phase is Formulation 1 in?

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.

What clinical trials is Formulation 1 in?

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.

Is Formulation 1 the same as Vericiguat?

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.