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Heart FailurePhase 1NCT05086952

A Study in Healthy Adult Male Participants to Learn the Way Vericiguat is Absorbed With and Without Food When Taken as a Single Dose in Liquid Form Suitable for Children Compared to a 10 Milligram (mg) Tablet That Releases the Active Substance Immediately

A Phase 1 study testing Vericiguat (BAY1021189) - Intervention A, Vericiguat (BAY1021189) - Intervention B and Vericiguat (BAY1021189) - Intervention C in people with Heart Failure and Children, run by Bayer at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Researchers are looking for a better way to treat heart failure, a condition in which the heart does not pump blood as well as it should. Heart failure can happen in both adults and children. The study treatment, vericiguat, is already available for doctors to give to adults who have heart failure. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Heart Failure, Children
What is being tested?
Vericiguat (BAY1021189) - Intervention A, Vericiguat (BAY1021189) - Intervention B and Vericiguat (BAY1021189) - Intervention C
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteGermany
Study dates
12 Oct 2021to 15 Feb 2022
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
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy male subjects
  • Age 18 -45 years
  • Body Mass Index (BMI): above or equal 18.5 and below or equal 29.9 kg / m²

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
  • Febrile illness (temperature ≥38.0 oC) within 4 weeks prior to admission to the ward
  • 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
  • Relevant diseases within the last 4 weeks prior to the first study intervention administration
  • Known gastro-intestinal disorders (e.g. stomach ulcers, duodenal ulcers, gastro-intestinal bleeding) or inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis)
Show all 10Show fewer
  • Regular use of medicines in the 4 weeks prior to first dosing
  • Regular use of therapeutic or recreational drugs (e.g. carnitine products, anabolics, high-dose vitamins)
  • Use of medication (prescription or over the counter) or herbal products within 2 weeks before first study intervention administration which could oppose the study objectives or which might influence them
  • Criteria which in the opinion of the investigator preclude participation for scientific reasons, for reasons of compliance, or for reasons of the participant's safety

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • SocraTec R&D GmbH

    Erfurt, Thuringia, 99084

Other trials in Germany

About this study

Official title: Pivotal Relative Bioavailability Study to Investigate the Pharmacokinetics and Food Effect of Single Oral Doses of Vericiguat Given as Pediatric Oral Suspension Formulations in Comparison to the 10 mg IR Tablet in Healthy Male Participants in a Randomized, Open-label, 4-fold Crossover Design

Researchers are looking for a better way to treat heart failure, a condition in which the heart does not pump blood as well as it should. Heart failure can happen in both adults and children.

The study treatment, vericiguat, is already available for doctors to give to adults who have heart failure. It works by increasing the activity of an enzyme called soluble guanylate cyclase (sGC). The sGC enzyme helps regulate the heart and blood circulation.

Read more

The current form of vericiguat is a tablet that releases the "active substance" immediately. The "active substance" is the part of the drug that works in the body to treat the condition. Vericiguat is currently only available as a treatment for adults. Researchers think vericiguat could help treat children with heart failure, but think it will be easiest for them to take a liquid treatment.

Another study is planned to find out how well vericiguat works in children who have a specific type of heart failure. Before researchers can give vericiguat to children, they must first study different doses and ways of taking vericiguat in adults. In this study, the researchers will study a new liquid form of vericiguat in adults. This form is also known as the "pediatric formulation".

In this study, the researchers want to find out how the new pediatric formulation of vericiguat moves into, through, and out of the body compared to the currently approved tablet form for adults. The researchers also want to find out if eating food affects the new pediatric formulation differently than the current tablet form of vericiguat.

The study will include about 36 healthy white male participants aged between 18 and 45 years old.

During this study, the participants will all take 4 different treatments in different orders. They will take:

  • a high dose of vericiguat in the new pediatric formulation, with food
  • a high dose of vericiguat in the new pediatric formulation, without food
  • a low dose of vericiguat in the new pediatric formulation, with food
  • a dose of the currently available tablet form, with food While taking each study treatment, the participants will stay at the study site for 4 days. There will be a break of at least 10 days between each treatment. Overall, the participants will be in this study for about 11 weeks.

During the study, the participants will:

  • have blood and urine samples taken
  • have their overall health and heart health checked
  • answer questions about how the new pediatric formulation tastes
  • answer questions about any 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 that happen in studies, even if they do not think the adverse events might be related to the study treatments.
Being tested
Vericiguat (BAY1021189) - Intervention A, Vericiguat (BAY1021189) - Intervention B, Vericiguat (BAY1021189) - Intervention C, Vericiguat (Verquvo, BAY1021189) - Intervention D
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vericiguat (BAY1021189) - Intervention ADrug

    Single dose of 10 mg vericiguat high-concentration pediatric formulation (oral liquid formulation) in fed state.

  • Vericiguat (BAY1021189) - Intervention BDrug

    Single dose of 10 mg vericiguat high-concentration pediatric formulation (oral liquid formulation) in fasted state.

  • Vericiguat (BAY1021189) - Intervention CDrug

    Single dose of 2.5 mg vericiguat low-concentration pediatric formulation (oral liquid formulation) in fed state.

  • Vericiguat (Verquvo, BAY1021189) - Intervention DDrug

    Single dose of 10 mg vericiguat immediate release (IR) intact tablet in fed state.

Study groups in NCT05086952
Study groupRoleWhat they receive
B-A-D-CExperimental4-fold crossover design with 4 interventions, 4 intervention periods, and 4 intervention sequences. (according to Williams design [balanced for 1-period-carry-over]).
Receives: Drug: Vericiguat (BAY1021189) - Intervention A; Drug: Vericiguat (BAY1021189) - Intervention B; Drug: Vericiguat (BAY1021189) - Intervention C; Drug: Vericiguat (Verquvo, BAY1021189) - Intervention D
C-D-A-BExperimental4-fold crossover design with 4 interventions, 4 intervention periods, and 4 intervention sequences. (according to Williams design [balanced for 1-period-carry-over]).
Receives: Drug: Vericiguat (BAY1021189) - Intervention A; Drug: Vericiguat (BAY1021189) - Intervention B; Drug: Vericiguat (BAY1021189) - Intervention C; Drug: Vericiguat (Verquvo, BAY1021189) - Intervention D
D-B-C-AExperimental4-fold crossover design with 4 interventions, 4 intervention periods, and 4 intervention sequences. (according to Williams design [balanced for 1-period-carry-over]).
Receives: Drug: Vericiguat (BAY1021189) - Intervention A; Drug: Vericiguat (BAY1021189) - Intervention B; Drug: Vericiguat (BAY1021189) - Intervention C; Drug: Vericiguat (Verquvo, BAY1021189) - Intervention D
A-C-B-DExperimental4-fold crossover design with 4 interventions, 4 intervention periods, and 4 intervention sequences. (according to Williams design [balanced for 1-period-carry-over]).
Receives: Drug: Vericiguat (BAY1021189) - Intervention A; Drug: Vericiguat (BAY1021189) - Intervention B; Drug: Vericiguat (BAY1021189) - Intervention C; Drug: Vericiguat (Verquvo, BAY1021189) - Intervention D

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AUC of vericiguat (a single oral dose of the pediatric high concentration formulation in comparison to vericiguat intact tablet in fed condition)

    AUC: area under the concentration vs. time curve from zero to infinity after single (first) dose, calculated up by linear trapezoidal rule, down by logarithmic trapezoidal rule

    Measured: From pre-dose until 72 hours after dosing in each intervention period

  2. AUC(0-tlast) of vericiguat (a single oral dose of the pediatric high concentration formulation in comparison to vericiguat intact tablet in fed condition)

    AUC(0-tlast): AUC from time 0 to the last data point > lower limit of quantitation (LLOQ)

    Measured: From pre-dose until 72 hours after dosing in each intervention period

  3. Cmax of vericiguat (a single oral dose of the pediatric high concentration formulation in comparison to vericiguat intact tablet in fed condition)

    Cmax: maximum observed drug concentration in measured matrix after single dose administration

    Measured: From pre-dose until 72 hours after dosing in each intervention period

Secondary outcomes (11)

  1. AUC/D of vericiguat ( a single oral dose of 2.5 mg of the pediatric low-concentration formulation in comparison to 10 mg vericiguat intact tablet in fed condition)

    AUC/D: AUC divided by dose

    Measured: From pre-dose until 72 hours after dosing in each intervention period

  2. AUC(0-tlast)/D of vericiguat ( a single oral dose of 2.5 mg of the pediatric low-concentration formulation in comparison to 10 mg vericiguat intact tablet in fed condition)

    AUC(0-tlast)/D: AUC from time 0 to the last data point divided by dose

    Measured: From pre-dose until 72 hours after dosing in each intervention period

  3. Cmax/D of vericiguat ( a single oral dose of 2.5 mg of the pediatric low-concentration formulation in comparison to 10 mg vericiguat intact tablet in fed condition)

    Cmax/D: Cmax divided by dose

    Measured: From pre-dose until 72 hours after dosing in each intervention period

  4. AUC/D of vericiguat (a single oral dose of 10 mg of the pediatric high-concentration formulation in comparison to a single oral dose of 2.5 mg of the pediatric low-concentration formulation in fed condition)

    Measured: From pre-dose until 72 hours after dosing in each intervention period

  5. AUC(0-tlast)/D of vericiguat (a single oral dose of 10 mg of the pediatric high-concentration formulation in comparison to a single oral dose of 2.5 mg of the pediatric low-concentration formulation in fed condition)

    Measured: From pre-dose until 72 hours after dosing in each intervention period

  6. Cmax/D of vericiguat (a single oral dose of 10 mg of the pediatric high-concentration formulation in comparison to a single oral dose of 2.5 mg of the pediatric low-concentration formulation in fed condition)

    Measured: From pre-dose until 72 hours after dosing in each intervention period

  7. Number of participants with treatment emergent adverse events (TEAEs)

    Measured: From dosing to 5 days after each dose per period (estimate duration is 20 days)

  8. Questionnaire by means of descriptive statistics

    Questionnaire to assess the taste, smell, and appearance of the newly developed pediatric formulation of vericiguat.

    Measured: 0 - 30 minutes

  9. AUC of vericiguat (a high fat, high calorie meal on the PK of vericiguat after a single oral dose of high-concentration pediatric formulation in comparison to the fasted state)

    Measured: From pre-dose until 72 hours after dosing in each intervention period

  10. AUC(0-tlast) of vericiguat (a high fat, high calorie meal on the PK of vericiguat after a single oral dose of high-concentration pediatric formulation in comparison to the fasted state)

    Measured: From pre-dose until 72 hours after dosing in each intervention period

  11. Cmax of vericiguat (a high fat, high calorie meal on the PK of vericiguat after a single oral dose of high-concentration pediatric formulation in comparison to the fasted state)

    Measured: From pre-dose until 72 hours after dosing in each intervention period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2021
  2. Study start12 Oct 2021
  3. Primary completion22 Dec 2021
  4. Study completion15 Feb 2022

Resources

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
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05086952
Sponsor's protocol ID
21150
Other IDs
2021-001199-40
Status last verified
Jan 2023
First submitted
1 Oct 2021
Last updated
2 Feb 2023
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.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Vericiguat (BAY1021189) - Intervention A, Vericiguat (BAY1021189) - Intervention B and Vericiguat (BAY1021189) - Intervention C in people with Heart Failure and Children, 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 3 inclusion and 10 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 2 Feb 2023. 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?

AUC of vericiguat (a single oral dose of the pediatric high concentration formulation in comparison to vericiguat intact tablet in fed condition) (time frame: From pre-dose until 72 hours after dosing in each intervention period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05086952.

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 2 Feb 2023.

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