Heart FailurePhase 1NCT06474208
A Study to Learn About the Taste of Vericiguat Given in Liquid Form in Healthy Male Participants Aged 18 to 45 Years
A Phase 1 study testing Formulation 1, Formulation 2 and Formulation 3 in people with Heart Failure, run by Bayer at 1 site in Germany.
Trial summary
Heart failure is a condition in which the heart does not pump blood as well as it should. It can happen in both adults and children. The study treatment, vericiguat, also called BAY1021189, is already approved for doctors to give to adults who have heart failure, particularly those with an ejection fraction (EF)… Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- Formulation 1, Formulation 2 and Formulation 3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jul 2024to 30 Sep 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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 Index (BMI) within the range [18.5 - 29.9] kg/m^2 (inclusive).
- Male.
- Ability to assess the required taste profile investigated in this study based on test assessments.
Who cannot join
- Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal.
- Known hypersensitivity to the study drugs (active substances or excipients of the preparations).
- A history of relevant diseases of vital organs, of the central nervous system or other organs.
- A history of relevant smell and / or taste disorders.
- Regular use of therapeutic or recreational drugs (e.g. carnitine products, anabolics, high-dose vitamins).
- Clinically relevant findings in the electrocardiogram (ECG) such as a second- or third-degree atrio-ventricular (AV) block, prolongation of the QRS complex over 120 msec or of the QTcF (QT interval corrected using Fridericia's formula)-interval over 450 msec.
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- Systolic blood pressure below 100 or above 140 mmHg.
- Diastolic blood pressure below 60 or above 90 mmHg.
- Heart rate below 50 or above 90 beats / min.
- Clinically relevant findings in the physical examination.
- Smoking (including vaping) within the last 21 days before screening.
- Unable to abstain from alcohol from 48 h prior to study intervention administration until discharge from the study ward.
- Unable to abstain from xanthine-containing beverages or food (coffee, tea, cola, chocolate, "power drinks") from 12 h prior to study intervention administration until 4 h after administration.
- History of COVID-19 (coronavirus disease 2019) within 3 months before screening.
- Long-COVID-19 syndrome or other clinically relevant COVID-19-related symptoms or sequels.
- Positive SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2) test.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Clinical Research Services | Clinical Research Services Mannheim - Phase one unit
Mannheim, Baden-Wurttemberg, 68167
About this study
Official title: A Phase 1, Single-blind, Randomized, 5-fold Crossover Taste Panel Study to Investigate the Taste Profile of an Oral Suspension of BAY 1021189 (Vericiguat) in Healthy Male Participants 18 to 45 Years of Age.
Heart failure is a condition in which the heart does not pump blood as well as it should. It can happen in both adults and children. The study treatment, vericiguat, also called BAY1021189, is already approved for doctors to give to adults who have heart failure, particularly those with an ejection fraction (EF) reduced to less than 45%. An EF is a measurement, expressed as a percentage, of how much blood is pumped with each heartbeat. An EF of less than 45% indicates a reduced ability of the heart to pump blood effectively. This results in a reduced supply of the oxygen that the body requires to function properly.
Vericiguat works by increasing the activity of a protein called soluble guanylate cyclase (sGC). sGC helps widen blood vessels, which in turn improves the heart function. Vericiguat is currently only available as a treatment for adults. Researchers think vericiguat could help treat children with heart failure and it will be easier for them to take a liquid treatment.
Read more
The main purpose of this study is to find out how the taste of the liquid form of vericiguat for children changes when different amounts of flavor improvers are added.
During the study, participants will take 5 different study drugs in different orders. They will take:
- Vericiguat: 4 different formulations of vericiguat which are flavored differently.
- Placebo: A placebo that looks like vericiguat but does not have any medicine in it.
Participants will taste these formulations or placebo but will not swallow them.
During the study, the doctors and their study team will:
- check participants' health by performing tests such as blood and urine tests.
- measure vital signs, including blood pressure and heart rate.
- check heart health using an electrocardiogram (ECG). An ECG is a test that records the electrical activity of the heart.
- ask the participants open questions about how they are feeling and what adverse events they are having.
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatment.
- Conditions
- Heart Failure
- Being tested
- Formulation 1, Formulation 2, Formulation 3, Formulation 4, Formulation 5 (placebo)
- Keywords
- Children
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Formulation 1Drug
Oral suspension of Vericiguat (BAY1021189) in single dose (SD).
Formulation 2Drug
Oral suspension of Vericiguat (BAY1021189) with increased level of sucralose in SD.
Formulation 3Drug
Oral suspension of Vericiguat (BAY1021189) with increased level of flavor in SD.
Formulation 4Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Formulation 1; Drug: Formulation 2; Drug: Formulation 3; Drug: Formulation 4; Drug: Formulation 5 (placebo) |
| 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. Receives: Drug: Formulation 1; Drug: Formulation 2; Drug: Formulation 3; Drug: Formulation 4; Drug: Formulation 5 (placebo) |
| 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. Receives: Drug: Formulation 1; Drug: Formulation 2; Drug: Formulation 3; Drug: Formulation 4; Drug: Formulation 5 (placebo) |
| 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. Receives: Drug: Formulation 1; Drug: Formulation 2; Drug: Formulation 3; Drug: Formulation 4; Drug: Formulation 5 (placebo) |
| 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. Receives: Drug: Formulation 1; Drug: Formulation 2; Drug: Formulation 3; Drug: Formulation 4; Drug: Formulation 5 (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Taste questionnaire by means of descriptive statistics
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.
Measured: Directly after study intervention administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start1 Jul 2024
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06474208
- Sponsor's protocol ID
- 22342
- Other IDs
- 2023-508447-52-00, 2023
- Status last verified
- Oct 2024
- First submitted
- 20 Jun 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-blind, Randomized, 5-fold Crossover Taste Panel Study to Investigate the Taste Profile of an Oral Suspension of BAY 1021189 (Vericiguat) in Healthy Male Participants 18 to 45 Years of Age.
- ClinicalTrials.gov ID
- NCT06474208
- Acronym / sponsor ID
- 22342
- Conditions
- Heart Failure
- Keywords
- Children
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 25 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Heart failure is a condition in which the heart does not pump blood as well as it should. It can happen in both adults and children. The study treatment, vericiguat, also called BAY1021189, is already approved for doctors to give to adults who have heart failure, particularly those with an ejection fraction (EF) reduced to less than 45%. An EF is a measurement, expressed as a percentage, of how much blood is pumped with each heartbeat. An EF of less than 45% indicates a reduced ability of the heart to pump blood effectively. This results in a reduced supply of the oxygen that the body requires to function properly.
Vericiguat works by increasing the activity of a protein called soluble guanylate cyclase (sGC). sGC helps widen blood vessels, which in turn improves the heart function. Vericiguat is currently only available as a treatment for adults. Researchers think vericiguat could help treat children with heart failure and it will be easier for them to take a liquid treatment.
The main purpose of this study is to find out how the taste of the liquid form of vericiguat for children changes when different amounts of flavor improvers are added.
During the study, participants will take 5 different study drugs in different orders. They will take:
- Vericiguat: 4 different formulations of vericiguat which are flavored differently.
- Placebo: A placebo that looks like vericiguat but does not have any medicine in it.
Participants will taste these formulations or placebo but will not swallow them.
During the study, the doctors and their study team will:
- check participants' health by performing tests such as blood and urine tests.
- measure vital signs, including blood pressure and heart rate.
- check heart health using an electrocardiogram (ECG). An ECG is a test that records the electrical activity of the heart.
- ask the participants open questions about how they are feeling and what adverse events they are having.
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Intervention sequence 1 | Experimental | Drug: Formulation 1, Drug: Formulation 2, Drug: Formulation 3, Drug: Formulation 4, Drug: Formulation 5 (placebo)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 | Drug: Formulation 1, Drug: Formulation 2, Drug: Formulation 3, Drug: Formulation 4, Drug: Formulation 5 (placebo)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 | Drug: Formulation 1, Drug: Formulation 2, Drug: Formulation 3, Drug: Formulation 4, Drug: Formulation 5 (placebo)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 | Drug: Formulation 1, Drug: Formulation 2, Drug: Formulation 3, Drug: Formulation 4, Drug: Formulation 5 (placebo)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 | Drug: Formulation 1, Drug: Formulation 2, Drug: Formulation 3, Drug: Formulation 4, Drug: Formulation 5 (placebo)Subjects will receive 5 different formulations in sequence No. 5. The intervention administrations will be separated by a washout phase of 24 h. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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 Index (BMI) within the range [18.5 - 29.9] kg/m^2 (inclusive).
- Male.
- Ability to assess the required taste profile investigated in this study based on test assessments.
Key exclusion criteria (16 listed)
- Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal.
- Known hypersensitivity to the study drugs (active substances or excipients of the preparations).
- A history of relevant diseases of vital organs, of the central nervous system or other organs.
- A history of relevant smell and / or taste disorders.
- Regular use of therapeutic or recreational drugs (e.g. carnitine products, anabolics, high-dose vitamins).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Formulation 1Oral suspension of Vericiguat (BAY1021189) in single dose (SD). | Drug | Intervention sequence 1, Intervention sequence 2, Intervention sequence 3, Intervention sequence 4, Intervention sequence 5 |
| Formulation 2Oral suspension of Vericiguat (BAY1021189) with increased level of sucralose in SD. | Drug | Intervention sequence 1, Intervention sequence 2, Intervention sequence 3, Intervention sequence 4, Intervention sequence 5 |
| Formulation 3Oral suspension of Vericiguat (BAY1021189) with increased level of flavor in SD. | Drug | Intervention sequence 1, Intervention sequence 2, Intervention sequence 3, Intervention sequence 4, Intervention sequence 5 |
| Formulation 4Oral suspension of Vericiguat (BAY1021189) with increased level of sucralose and flavor in SD. | Drug | Intervention sequence 1, Intervention sequence 2, Intervention sequence 3, Intervention sequence 4, Intervention sequence 5 |
| Formulation 5 (placebo)Matching placebo of formulation 1 in SD. | Drug | Intervention sequence 1, Intervention sequence 2, Intervention sequence 3, Intervention sequence 4, Intervention sequence 5 |
Primary outcome
Taste questionnaire by means of descriptive statistics
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Individual participant dataSharing planned: No. Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Formulation 1, Formulation 2 and Formulation 3 in people with Heart Failure, run by Bayer at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Taste questionnaire by means of descriptive statistics (time frame: Directly after study intervention administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.