Congestive Heart FailurePhase 1NCT05599997
A Study to Learn How the Study Treatment BAY1753011 Moves Into, Through and Out of the Body, How it Works, How Safe it is, and How it Affects the Body When Given Once as Tablet in Male and Female Participants With Reduced Kidney Function Compared to Matched Participants With Normal Kidney Function
A Phase 1 study testing Pecavaptan (BAY1753011) in people with Congestive Heart Failure and Renal Impairment, run by Bayer at 2 sites in Germany.
Trial summary
Researchers are looking for a better way to treat people with heart failure. Heart failure is a condition which occurs when the heart does not pump blood as well as it should leading to shortness of breath, tiredness, and ankle swelling. The study treatment BAY1753011 is under development to treat heart failure. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Congestive Heart Failure, Renal Impairment
- What is being tested?
- Pecavaptan (BAY1753011)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesGermany
- Study dates
- 25 Nov 2019to 18 May 2021
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female White participants (women without childbearing potential)
- Aged from ≥18 years
- body mass index above or equal 18.5 kg/m2 and below or equal 36 kg/m2 at the first screening visit
- Participants with renal impairment: with an eGFR <90 mL/min/1.73 m^2 determined from serum creatinine 21-3 days prior to dosing using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation
- Age-, weight- and gender- matched control group
Who cannot join
- An anatomical abnormality of the gut that could affect the retention times of the drug in the stomach/gut adversely
- Conditions or concomitant treatment that might adversely affect the gastric pH level
- Pancreatic dysfunction/insufficiency
- Febrile illness within 4 week prior to admission to study center
- Known hypersensitivity to the study drugs
- Known severe allergies, non-allergic drug reactions, or multiple drug allergies
Show all 18Show fewer
- Participants with a medical disorder, condition or history of such that would impair the participant's ability to participate or complete this study in the opinion of the investigator or the Sponsor
- Concomitant treatment from 2 weeks before study drug administration until end of follow-up with drugs that may impact the PK of BAY 1753011:Strong and moderate inducers or inhibitors of CYP3A4Moderate and strong inhibitors of P-gp transport Probenecid and valproic acid
- Concomitant treatment with potassium-sparing diuretic (with the exception of mineralocorticoid- receptor antagonist [MRA]) that cannot be stopped prior to randomization and for the duration of the treatment period
- Although no clinical study data are available for BAY 1753011, drugs for the treatment of hyperphosphatemia such as sevelamer or lanthanum should not be given from 24 h before until 24 h after dosing, as they are known to bind many anionic drugs
- Acute renal failure
- Active nephritis
- Severe infection or any clinically significant illness within 4 weeks prior to dosing
- Impairment of any other major organ system other than the kidney
- Clinically relevant findings in the ECG such as a second- or third-degree atrioventricular (AV) block, prolongation of the QTc-interval over 480 msec
- Systolic blood pressure below 100 or above 160 mmHg
- Diastolic blood pressure below 50 or above 100 mmHg
- Heart rate below 50 or above 100 beats/ min
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
CRS Clinical-Research-Services Kiel GmbH
Kiel, Schleswig-Holstein, 24105
APEX GmbH
München, Bavaria, 81241
About this study
Official title: Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of a Single Oral Dose of 30 mg BAY 1753011 Given as IR Tablet in Male and Female Participants in a Multicenter, Non-randomized, Non-controlled, Non-blinded Study With Group Stratification in Participants With Renal Impairment and Control Group Matched for Age-, Gender-, and Weight
Researchers are looking for a better way to treat people with heart failure. Heart failure is a condition which occurs when the heart does not pump blood as well as it should leading to shortness of breath, tiredness, and ankle swelling.
The study treatment BAY1753011 is under development to treat heart failure. It is thought to reduce the action of a hormone called vasopressin that is naturally produced in the body. People with heart failure often have elevated levels of vasopressin. This is known to result in worsening of the heart failure condition.
Read more
People with heart failure often also have reduced kidney functions. As kidneys play a role in removal of drugs from the body, reduced kidney function may result in higher blood levels of BAY1753011.
The main purpose of this study was to learn how BAY1753011 moved into, through and out of the body in participants with different degrees of reduced kidney function compared to matched participants (age, gender, and weight) with normal kidney function.
To answer this, the researchers compared:
- the (average) total level of BAY1753011 in the blood (also called AUC)
- the (average) highest level of BAY1753011 in the blood (also called Cmax) between the different groups with reduced kidney function (mild/moderate/severe) and the control group (normal kidney function).
In addition, the researchers wanted to know how safe BAY1753011 was and the degree to which overt medical problems caused by it could be tolerated (also called tolerability) by the different groups of participants.
These medical problems are also known as "adverse events". Doctors keep track of all medical problems that happen in studies, even if they do not think they might be related to the study treatments.
All participants took a single dose of BAY1753011 in tablet form by mouth. Each participant was in the study for approximately 3 to 4 weeks, including an in-house phase of 5 days and 4 nights with one treatment day.
During the study, the doctors and their study team:
- did physical examinations
- checked vital signs such as blood pressure, heart rate, body temperature and number of breaths within a minute (respiratory rate)
- examined heart health using electrocardiogram (ECG)
- took blood and urine samples
- counted the number of toilet visits during the night
- Conditions
- Congestive Heart Failure, Renal Impairment
- Being tested
- Pecavaptan (BAY1753011)
- Medical subject headings
- Heart Failure, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pecavaptan (BAY1753011)Drug
30 mg, immediate release tablet, single dose, oral
Pecavaptan (BAY1753011)Drug
15 mg, immediate release tablet, single dose, oral
| Study group | Role | What they receive |
|---|---|---|
| Healthy | Experimental | Age-, weight- and gender- matched control group of healthy volunteers received a single oral dose of 30 mg BAY1753011 tablet. Receives: Drug: Pecavaptan (BAY1753011) |
| Mild renal impairment | Experimental | Subjects with mild renal impairment received a single oral dose of 30 mg BAY1753011 tablet. Receives: Drug: Pecavaptan (BAY1753011) |
| Moderate renal impairment | Experimental | Subjects with moderate renal impairment received a single oral dose of 30 mg BAY1753011 tablet. Receives: Drug: Pecavaptan (BAY1753011) |
| Severe renal impairment | Experimental | Subjects with severe renal impairment received a single oral dose of 15 mg BAY1753011 tablet. Receives: Drug: Pecavaptan (BAY1753011) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration versus time curve from zero to infinity divided by dose of total BAY1753011 in plasma after single dose administration (AUC/D)
Dose-normalized AUC (AUC/D) of BAY1753011 was investigated as the dose for the severe renal impairment group was reduced to 15 mg.
Measured: From pre-dose until 144 hours post dose
Maximum observed drug concentration divided by dose of total BAY1753011 in plasma after single dose administration (Cmax/D)
Dose-normalized Cmax (Cmax/D) of BAY1753011 was investigated as the dose for the severe renal impairment group was reduced to 15 mg.
Measured: From pre-dose until 144 hours post dose
Area under the concentration versus time curve from zero to infinity divided by dose of unbound BAY1753011 in plasma after single dose administration (AUCu/D)
Dose-normalized AUCu (AUCu/D) of BAY1753011 was investigated as the dose for the severe renal impairment group was reduced to 15 mg.
Measured: From pre-dose until 144 hours post dose
Maximum observed drug concentration divided by dose of unbound BAY1753011 in plasma after single dose administration (Cmax,u/D)
Dose-normalized Cmax,u (Cmax,u/D) of BAY1753011 was investigated as the dose for the severe renal impairment group was reduced to 15 mg.
Measured: From pre-dose until 144 hours post dose
Secondary outcomes (1)
Number of participants with treatment-emergent adverse events
Measured: After first application of study medication up to 10 days after the study medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study start25 Nov 2019
- Primary completion22 Jan 2021
- Study completion18 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05599997
- Sponsor's protocol ID
- 19482
- Other IDs
- 2019-000876-41, 2019
- Status last verified
- Oct 2022
- First submitted
- 26 Oct 2022
- Last updated
- 31 Oct 2022
- 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 31 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of a Single Oral Dose of 30 mg BAY 1753011 Given as IR Tablet in Male and Female Participants in a Multicenter, Non-randomized, Non-controlled, Non-blinded Study With Group Stratification in Participants With Renal Impairment and Control Group Matched for Age-, Gender-, and Weight
- ClinicalTrials.gov ID
- NCT05599997
- Acronym / sponsor ID
- 19482
- Conditions
- Congestive Heart Failure, Renal Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 25 Nov 2019 (actual)
- Primary completion
- 22 Jan 2021 (actual)
- Study completion
- 18 May 2021 (actual)
- First posted
- 31 Oct 2022 (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.
Researchers are looking for a better way to treat people with heart failure. Heart failure is a condition which occurs when the heart does not pump blood as well as it should leading to shortness of breath, tiredness, and ankle swelling.
The study treatment BAY1753011 is under development to treat heart failure. It is thought to reduce the action of a hormone called vasopressin that is naturally produced in the body. People with heart failure often have elevated levels of vasopressin. This is known to result in worsening of the heart failure condition.
People with heart failure often also have reduced kidney functions. As kidneys play a role in removal of drugs from the body, reduced kidney function may result in higher blood levels of BAY1753011.
The main purpose of this study was to learn how BAY1753011 moved into, through and out of the body in participants with different degrees of reduced kidney function compared to matched participants (age, gender, and weight) with normal kidney function.
To answer this, the researchers compared:
- the (average) total level of BAY1753011 in the blood (also called AUC)
- the (average) highest level of BAY1753011 in the blood (also called Cmax) between the different groups with reduced kidney function (mild/moderate/severe) and the control group (normal kidney function).
In addition, the researchers wanted to know how safe BAY1753011 was and the degree to which overt medical problems caused by it could be tolerated (also called tolerability) by the different groups of participants.
These medical problems are also known as "adverse events". Doctors keep track of all medical problems that happen in studies, even if they do not think they might be related to the study treatments.
All participants took a single dose of BAY1753011 in tablet form by mouth. Each participant was in the study for approximately 3 to 4 weeks, including an in-house phase of 5 days and 4 nights with one treatment day.
During the study, the doctors and their study team:
- did physical examinations
- checked vital signs such as blood pressure, heart rate, body temperature and number of breaths within a minute (respiratory rate)
- examined heart health using electrocardiogram (ECG)
- took blood and urine samples
- counted the number of toilet visits during the night
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy | Experimental | Drug: Pecavaptan (BAY1753011)Age-, weight- and gender- matched control group of healthy volunteers received a single oral dose of 30 mg BAY1753011 tablet. |
| Mild renal impairment | Experimental | Drug: Pecavaptan (BAY1753011)Subjects with mild renal impairment received a single oral dose of 30 mg BAY1753011 tablet. |
| Moderate renal impairment | Experimental | Drug: Pecavaptan (BAY1753011)Subjects with moderate renal impairment received a single oral dose of 30 mg BAY1753011 tablet. |
| Severe renal impairment | Experimental | Drug: Pecavaptan (BAY1753011)Subjects with severe renal impairment received a single oral dose of 15 mg BAY1753011 tablet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female White participants (women without childbearing potential)
- Aged from ≥18 years
- body mass index above or equal 18.5 kg/m2 and below or equal 36 kg/m2 at the first screening visit
- Participants with renal impairment: with an eGFR <90 mL/min/1.73 m^2 determined from serum creatinine 21-3 days prior to dosing using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation
- Age-, weight- and gender- matched control group
Key exclusion criteria (18 listed)
- An anatomical abnormality of the gut that could affect the retention times of the drug in the stomach/gut adversely
- Conditions or concomitant treatment that might adversely affect the gastric pH level
- Pancreatic dysfunction/insufficiency
- Febrile illness within 4 week prior to admission to study center
- Known hypersensitivity to the study drugs
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 |
|---|---|---|
| Pecavaptan (BAY1753011)30 mg, immediate release tablet, single dose, oral | Drug | Healthy, Mild renal impairment, Moderate renal impairment |
| Pecavaptan (BAY1753011)15 mg, immediate release tablet, single dose, oral | Drug | Severe renal impairment |
Primary outcome
Area under the concentration versus time curve from zero to infinity divided by dose of total BAY1753011 in plasma after single dose administration (AUC/D)
Time frame: From pre-dose until 144 hours post dose
Dose-normalized AUC (AUC/D) of BAY1753011 was investigated as the dose for the severe renal impairment group was reduced to 15 mg.
Maximum observed drug concentration divided by dose of total BAY1753011 in plasma after single dose administration (Cmax/D)
Time frame: From pre-dose until 144 hours post dose
Dose-normalized Cmax (Cmax/D) of BAY1753011 was investigated as the dose for the severe renal impairment group was reduced to 15 mg.
Area under the concentration versus time curve from zero to infinity divided by dose of unbound BAY1753011 in plasma after single dose administration (AUCu/D)
Time frame: From pre-dose until 144 hours post dose
Dose-normalized AUCu (AUCu/D) of BAY1753011 was investigated as the dose for the severe renal impairment group was reduced to 15 mg.
Maximum observed drug concentration divided by dose of unbound BAY1753011 in plasma after single dose administration (Cmax,u/D)
Time frame: From pre-dose until 144 hours post dose
Dose-normalized Cmax,u (Cmax,u/D) of BAY1753011 was investigated as the dose for the severe renal impairment group was reduced to 15 mg.
1 secondary outcome
Number of participants with treatment-emergent adverse events
Time frame: After first application of study medication up to 10 days after the study medication
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 31 Oct 2022.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pecavaptan (BAY1753011) in people with Congestive Heart Failure and Renal Impairment, run by Bayer at 2 sites 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 18 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 31 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Area under the concentration versus time curve from zero to infinity divided by dose of total BAY1753011 in plasma after single dose administration (AUC/D) (time frame: From pre-dose until 144 hours post dose). The study lists 4 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 31 Oct 2022.