Heart Failure With Left Ventricular Ejection Fraction Greater Than or Equal to 40 Per CentPhase 1NCT07116512
A Study to Compare How Much of the Study Treatment Finerenone Gets Into the Blood When the Same Amount is Taken in One and in Two Tablets of Different Strengths in Healthy Male Participants
A Phase 1 study testing Finerenone (BAY94-8862): intervention A and Finerenone (BAY94-8862): intervention B in people with Heart Failure With Left Ventricular Ejection Fraction Greater Than or Equal to 40 Per Cent and Healthy Volunteers, run by Bayer at 1 site in Germany.
Trial summary
In this bioequivalence study, healthy male participants took the study treatment finerenone in the form of one and two tablets of different strengths by mouth. "Bioequivalence" means that the researchers want to show similar blood levels of finerenone in the participants when they take the one tablet form of… Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Heart Failure With Left Ventricular Ejection Fraction Greater Than or Equal to 40 Per Cent, Healthy Volunteers
- What is being tested?
- Finerenone (BAY94-8862): intervention A and Finerenone (BAY94-8862): intervention B
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 2 May 2023to 28 Jul 2023
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
- Participants who were overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, body temperature, vital signs, and ECG.
- BMI within the range 18.0 to 29.9 kg/m^2 (inclusive) at the screening visit.
- Contraceptive used by men and female partners should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Who cannot join
- Known hypersensitivity to any study intervention (active substances or excipients of the preparations) to be used in the study - including e.g., non-investigational medicinal products, challenge agents, or rescue medication.
- Medical disorder, condition or history of such that would impair the participant's ability to take part in or complete this study in the opinion of the investigator.
- Diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study intervention(s) will not be normal.
- Use of systemic or topical medicines or substances which might influence the study objectives.
- Suspicion of drug or alcohol abuse.
Trial locations and contacts
1 site in 1 country.
Germany1 site
CRS Clinical Research Services Wuppertal GmbH
Wuppertal, North Rhine-Westphalia, 42113
About this study
Official title: Randomized, Non-blinded, Two-way Crossover Study to Assess Bioequivalence Between Finerenone Study Intervention A (Test) and Study Intervention B (Reference) in Healthy Male Adult Participants
In this bioequivalence study, healthy male participants took the study treatment finerenone in the form of one and two tablets of different strengths by mouth. "Bioequivalence" means that the researchers want to show similar blood levels of finerenone in the participants when they take the one tablet form of finerenone compared to the two tablets form. This study helped researchers learn more about a new finerenone tablet with higher strength, which is being developed to treat people who have heart failure (HF) with left ventricular ejection fraction (LVEF) ≥ 40%.
HF with LVEF ≥ 40% is a condition which occurs when the left side of the heart does not pump blood out to the body as well as it should. Over time, the body does not get the amount of oxygen it needs. This can lead to shortness of breath and tiredness, making it harder for people to do their daily tasks.
Read more
Finerenone works by blocking a certain protein, called mineralocorticoid receptor. By doing this, finerenone reduces damage to kidneys, heart and blood vessels. It is available and approved for doctors to prescribe to people with chronic kidney disease together with type 2 diabetes.
The main objective of this study was to compare how much finerenone gets into the blood when the participants took the same amount of finerenone in the form of one and two tablets of different strengths by mouth.
Another objective of this study was to learn the degree to which medical problems that might be caused by finerenone can be tolerated (also called "tolerability") by the participants. These medical problems were also known as "adverse events". Doctors kept track of all adverse events that happened in the study, even if they did not think they might be related to the study treatments.
The study was conducted in a single-center, randomized, non-blinded, two-way crossover design in healthy male participants aged 18 to 55 years.
"Single-center" means at one research center or one hospital. "Randomized" means that the study participants were randomly (by chance) assigned to one of two sequences of treatments. "Non-blinded" means that both the participants and the study doctors and their team know what the participants will take. In a "two-way crossover" study, all the participants take all of the treatments, but in a different order. Each participant was in the study for approximately 4-6 weeks including a stay in the center for up to 6 days with 5 overnight stays.
In this study, each participant took finerenone twice by mouth on an empty stomach. They took finerenone in the form of one and two tablets of different strengths. The tablet form that was taken first depended on the treatment sequence to which the participants were assigned. There was a period of 3 days between the intake of the tablets.
Each participant served as his/her own control. This means that researchers made comparisons between the two tablet forms of finerenone within the same participant.
During the study, the doctors and their study team took blood and urine samples, did physical examinations, performed ECG and checked vital signs such as blood pressure, heart rate and body temperature.
Participants of this study were healthy and had no benefit from taking the study treatment finerenone. However, the study provided information on how to use the new tablet form of finerenone to treat patients with HF with LVEF ≥ 40% Specific measures had been put in place to counter and minimize the risks related to the conduct of this study. Information on safety of finerenone was already available from previous studies. Monitoring procedures, limitation of given doses and exclusion criteria had been defined. Blood samples were taken via an indwelling catheter (up to 15 times on the treatment days and once the day after). One screening visit was planned up to 28 days before the start of treatment and one visit was planned about 7 days after the end of treatment.
The benefit-risk assessment was considered positive and justified the conduct of the planned study in healthy participants.
- Conditions
- Heart Failure With Left Ventricular Ejection Fraction Greater Than or Equal to 40 Per Cent, Healthy Volunteers
- Being tested
- Finerenone (BAY94-8862): intervention A, Finerenone (BAY94-8862): intervention B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Finerenone (BAY94-8862): intervention ADrug
Study intervention A: one tablet of dose strength 1 one tablet of dose strength 1 = two tablets of dose strength 2
Finerenone (BAY94-8862): intervention BDrug
Study intervention B: two tablets of dose strength 2 two tablets of dose strength 2 = one tablet of dose strength 1
| Study group | Role | What they receive |
|---|---|---|
| finerenone sequences: intervention A_intervention B | Experimental | Participants received intervention A first, with a washout period of at least 72 hours, participants then received intervention B Receives: Drug: Finerenone (BAY94-8862): intervention A; Drug: Finerenone (BAY94-8862): intervention B |
| finerenone sequences: intervention B_intervention A | Experimental | Participants received intervention B first, with a washout period of at least 72 hours, participants then received intervention A Receives: Drug: Finerenone (BAY94-8862): intervention A; Drug: Finerenone (BAY94-8862): intervention B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax for plasma finerenone concentration
Cmax: maximum concentration.
Measured: 0-24 h post dose
AUC(0-tlast) for plasma finerenone concentration
AUC = area under the curve, which was the total amount of finerenone in plasma
Measured: 0-24 h post dose
Secondary outcomes (1)
Number of participants with treatment emergent adverse events (TEAEs)
AEs were considered to be treatment-emergent if they have started or worsened after administration up to 3 days after end of treatment with study intervention.
Measured: After first administration of study intervention up to 3 days after end of treatment with study intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start2 May 2023
- Primary completion28 Jul 2023
- Study completion28 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Left Ventricular Ejection Fraction Greater Than or Equal to 40 Per CentStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Two-way crossover design
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07116512
- Sponsor's protocol ID
- 22292
- Other IDs
- 2022-502385-24
- Status last verified
- Jul 2024
- First submitted
- 6 Aug 2025
- Last updated
- 11 Aug 2025
- 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 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Non-blinded, Two-way Crossover Study to Assess Bioequivalence Between Finerenone Study Intervention A (Test) and Study Intervention B (Reference) in Healthy Male Adult Participants
- ClinicalTrials.gov ID
- NCT07116512
- Acronym / sponsor ID
- 22292
- Conditions
- Heart Failure With Left Ventricular Ejection Fraction Greater Than or Equal to 40 Per Cent, Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 2 May 2023 (actual)
- Primary completion
- 28 Jul 2023 (actual)
- Study completion
- 28 Jul 2023 (actual)
- First posted
- 11 Aug 2025 (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.
In this bioequivalence study, healthy male participants took the study treatment finerenone in the form of one and two tablets of different strengths by mouth. "Bioequivalence" means that the researchers want to show similar blood levels of finerenone in the participants when they take the one tablet form of finerenone compared to the two tablets form. This study helped researchers learn more about a new finerenone tablet with higher strength, which is being developed to treat people who have heart failure (HF) with left ventricular ejection fraction (LVEF) ≥ 40%.
HF with LVEF ≥ 40% is a condition which occurs when the left side of the heart does not pump blood out to the body as well as it should. Over time, the body does not get the amount of oxygen it needs. This can lead to shortness of breath and tiredness, making it harder for people to do their daily tasks.
Finerenone works by blocking a certain protein, called mineralocorticoid receptor. By doing this, finerenone reduces damage to kidneys, heart and blood vessels. It is available and approved for doctors to prescribe to people with chronic kidney disease together with type 2 diabetes.
The main objective of this study was to compare how much finerenone gets into the blood when the participants took the same amount of finerenone in the form of one and two tablets of different strengths by mouth.
Another objective of this study was to learn the degree to which medical problems that might be caused by finerenone can be tolerated (also called "tolerability") by the participants. These medical problems were also known as "adverse events". Doctors kept track of all adverse events that happened in the study, even if they did not think they might be related to the study treatments.
The study was conducted in a single-center, randomized, non-blinded, two-way crossover design in healthy male participants aged 18 to 55 years.
"Single-center" means at one research center or one hospital. "Randomized" means that the study participants were randomly (by chance) assigned to one of two sequences of treatments. "Non-blinded" means that both the participants and the study doctors and their team know what the participants will take. In a "two-way crossover" study, all the participants take all of the treatments, but in a different order. Each participant was in the study for approximately 4-6 weeks including a stay in the center for up to 6 days with 5 overnight stays.
In this study, each participant took finerenone twice by mouth on an empty stomach. They took finerenone in the form of one and two tablets of different strengths. The tablet form that was taken first depended on the treatment sequence to which the participants were assigned. There was a period of 3 days between the intake of the tablets.
Each participant served as his/her own control. This means that researchers made comparisons between the two tablet forms of finerenone within the same participant.
During the study, the doctors and their study team took blood and urine samples, did physical examinations, performed ECG and checked vital signs such as blood pressure, heart rate and body temperature.
Participants of this study were healthy and had no benefit from taking the study treatment finerenone. However, the study provided information on how to use the new tablet form of finerenone to treat patients with HF with LVEF ≥ 40% Specific measures had been put in place to counter and minimize the risks related to the conduct of this study. Information on safety of finerenone was already available from previous studies. Monitoring procedures, limitation of given doses and exclusion criteria had been defined. Blood samples were taken via an indwelling catheter (up to 15 times on the treatment days and once the day after). One screening visit was planned up to 28 days before the start of treatment and one visit was planned about 7 days after the end of treatment.
The benefit-risk assessment was considered positive and justified the conduct of the planned study in healthy participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-way crossover design
| Arm | Type | Receives |
|---|---|---|
| finerenone sequences: intervention A_intervention B | Experimental | Drug: Finerenone (BAY94-8862): intervention A, Drug: Finerenone (BAY94-8862): intervention BParticipants received intervention A first, with a washout period of at least 72 hours, participants then received intervention B |
| finerenone sequences: intervention B_intervention A | Experimental | Drug: Finerenone (BAY94-8862): intervention A, Drug: Finerenone (BAY94-8862): intervention BParticipants received intervention B first, with a washout period of at least 72 hours, participants then received intervention A |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
- Participants who were overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, body temperature, vital signs, and ECG.
- BMI within the range 18.0 to 29.9 kg/m^2 (inclusive) at the screening visit.
- Contraceptive used by men and female partners should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Key exclusion criteria (5 listed)
- Known hypersensitivity to any study intervention (active substances or excipients of the preparations) to be used in the study - including e.g., non-investigational medicinal products, challenge agents, or rescue medication.
- Medical disorder, condition or history of such that would impair the participant's ability to take part in or complete this study in the opinion of the investigator.
- Diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study intervention(s) will not be normal.
- Use of systemic or topical medicines or substances which might influence the study objectives.
- Suspicion of drug or alcohol abuse.
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 |
|---|---|---|
| Finerenone (BAY94-8862): intervention AStudy intervention A: one tablet of dose strength 1 one tablet of dose strength 1 = two tablets of dose strength 2 | Drug | finerenone sequences: intervention A_intervention B, finerenone sequences: intervention B_intervention A |
| Finerenone (BAY94-8862): intervention BStudy intervention B: two tablets of dose strength 2 two tablets of dose strength 2 = one tablet of dose strength 1 | Drug | finerenone sequences: intervention A_intervention B, finerenone sequences: intervention B_intervention A |
Primary outcome
Cmax for plasma finerenone concentration
Time frame: 0-24 h post dose
Cmax: maximum concentration.
AUC(0-tlast) for plasma finerenone concentration
Time frame: 0-24 h post dose
AUC = area under the curve, which was the total amount of finerenone in plasma
1 secondary outcome
Number of participants with treatment emergent adverse events (TEAEs)
Time frame: After first administration of study intervention up to 3 days after end of treatment with study intervention
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 11 Aug 2025.
- 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.
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 Finerenone (BAY94-8862): intervention A and Finerenone (BAY94-8862): intervention B in people with Heart Failure With Left Ventricular Ejection Fraction Greater Than or Equal to 40 Per Cent and Healthy Volunteers, 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 4 inclusion and 5 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 11 Aug 2025. 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?
Cmax for plasma finerenone concentration (time frame: 0-24 h post dose). The study lists 2 primary outcomes in all. 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 11 Aug 2025.