Heart FailurePhase 1NCT04722562
A Trial to Learn How Safe Vericiguat (BAY1021189) is and the Way the Body Absorbs, Distributes and Gets Rid of Vericiguat in Participants With Liver Disease and in Age-, Weight- and Gender-matched Healthy Participants
A Phase 1 study testing Vericiguat (BAY1021189) in people with Heart Failure, run by Bayer at 1 site in Germany.
Trial summary
Vericiguat (BAY1021189) is under development to treat heart failure, a condition in in which the heart has trouble pumping blood through the body. Liver impairment which co-occurs in patients with heart failure is a common condition in which the liver is not removing the drugs from the blood as well as it should. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- Vericiguat (BAY1021189)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteGermany
- Study dates
- 16 Jul 2014to 30 Apr 2015
- 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 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For all subjects:
- Aged between 18 and 79 years (inclusive) with body mass index 18 to 34 kg/m^2 (both inclusive)
- Women without childbearing potential; women of childbearing potential only if the pregnancy test was negative and a combination of condoms with a safe and highly effective
- For subjects with hepatic impairment:
- Subjects with documented liver cirrhosis confirmed by histopathology, e.g., previous liver biopsy, laparoscopy, ultrasound, or fibroscan
- Subjects with hepatic impairment (Child Pugh A or B)
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- Subjects with stable liver disease in the last 2 months
- For healthy subjects:
- Mean age and body weight in the control group and in the two groups with hepatic impairment (Child Pugh A and B) should not vary by more than ± 10 years and ± 10 kg
- Gender matched
Who cannot join
- For all subjects:
- Subjects with a medical disorder, condition, or history of such that would impair the subject's ability to participate or complete this study in the opinion of the investigator or the sponsor
- Medical history of Kock pouch (ileostomy after proctocolectomy)
- 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 gastrointestinal (GI) disorders (eg stomach ulcers, duodenal ulcers, GI bleeding) or inflammatory bowel disease (eg Crohn's disease, ulcerative colitis)
- Febrile illness within 1 week prior to admission to study center
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- Relevant diseases within the last 4 weeks prior to admission to study center
- Known severe allergies, non-allergic drug reactions, or multiple drug allergies
- Known hypersensitivity to the study drugs (active substances or excipients of the preparations)
- Subjects with diagnosed malignancy within the past 5 years
- For subjects with hepatic impairment:
- Severe cerebrovascular or cardiac disorders, e.g., myocardial infarction less than 6 months prior to dosing, congestive heart failure of New York Heart Association grade III or IV, severe arrhythmia requiring anti-arrhythmic treatment
- Evidence of hepatic encephalopathy related to chronic liver disease > grade 2 (exclusion by Number Connection Test (NCT))
- Subjects with percutaneous transluminal coronary angioplasty or coronary artery bypass graft less than 6 months prior to study drug administration
- History of bleeding within the past 3 months
- Thrombotic disorder
- Subjects with diabetes mellitus with a glycohemoglobin A1c (HbA1c) >10%
- Severe ascites of more than 6 L (estimated by ultrasound)
- Subjects with primary and secondary biliary cirrhosis
- Subjects with sclerosing cholangitis
- Failure of any other major organ system other than the liver
- Severe infection, malignancy, or psychosis, or any clinically significant illness within 4 weeks prior to study drug administration
- For healthy subjects:
- 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
- Subjects with conspicuous findings in medical history or pre-study examination
- A history of relevant diseases of vital organs, the central nervous system, or other organs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Pharmacokinetics, Safety, and Tolerability of Vericiguat (BAY1021189) in Subjects With Hepatic Impairment (Classified as Child Pugh A or B) and in Age-, Weight-, and Gender-matched Healthy Subjects Following a Single Oral Dose in a Single-center, Non-randomized, Non-controlled, Non-blinded, Observational Study With Group Stratification
Vericiguat (BAY1021189) is under development to treat heart failure, a condition in in which the heart has trouble pumping blood through the body. Liver impairment which co-occurs in patients with heart failure is a common condition in which the liver is not removing the drugs from the blood as well as it should.
The goal of the study was to learn more about the safety of vericiguat (BAY1021189), how it was tolerated and the way the body absorbed, distributed and excreted the study dug given as a single oral dose of 2.5 mg tablet in participants with liver impairment and healthy participants matched for age-, gender-, and weight.
The participants stayed at the trial site for about 5 days. During this time, the doctors took blood and urine samples and checked the participants' health. About 7 after the participants took vericiguat (BAY1021189), the researchers checked the participants' health again and asked about any medical problems they had.
- Conditions
- Heart Failure
- Being tested
- Vericiguat (BAY1021189)
- 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)Drug
Oral single dose of 2.5 mg (2 x 1.25 mg immediate release tablet)
| Study group | Role | What they receive |
|---|---|---|
| Child Pugh A | Experimental | Participants with mild hepatic impairment Receives: Drug: Vericiguat (BAY1021189) |
| Child Pugh B | Experimental | Participants with moderate hepatic impairment Receives: Drug: Vericiguat (BAY1021189) |
| Healthy participants | Experimental | Participants with normal hepatic function Receives: Drug: Vericiguat (BAY1021189) |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC of vericiguat
Area under the concentration vs. time curve from zero to infinity after single dose administration
Measured: Up to 96 hours
AUCu of vericiguat
AUC unbound
Measured: Up to 96 hours
Cmax of vericiguat
Maximum observed drug concentration in measured matrix after single dose administration
Measured: Up to 96 hours
Cmax,u of vericiguat
Cmax unbound
Measured: Up to 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start16 Jul 2014
- Primary completion21 Jan 2015
- Study completion30 Apr 2015
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04722562
- Sponsor's protocol ID
- 15840
- Other IDs
- 2014-001206-18, 2014
- Status last verified
- Jan 2021
- First submitted
- 21 Jan 2021
- Last updated
- 25 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Pharmacokinetics, Safety, and Tolerability of Vericiguat (BAY1021189) in Subjects With Hepatic Impairment (Classified as Child Pugh A or B) and in Age-, Weight-, and Gender-matched Healthy Subjects Following a Single Oral Dose in a Single-center, Non-randomized, Non-controlled, Non-blinded, Observational Study With Group Stratification
- ClinicalTrials.gov ID
- NCT04722562
- Acronym / sponsor ID
- 15840
- Conditions
- Heart Failure
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 16 Jul 2014 (actual)
- Primary completion
- 21 Jan 2015 (actual)
- Study completion
- 30 Apr 2015 (actual)
- First posted
- 25 Jan 2021 (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.
Vericiguat (BAY1021189) is under development to treat heart failure, a condition in in which the heart has trouble pumping blood through the body. Liver impairment which co-occurs in patients with heart failure is a common condition in which the liver is not removing the drugs from the blood as well as it should.
The goal of the study was to learn more about the safety of vericiguat (BAY1021189), how it was tolerated and the way the body absorbed, distributed and excreted the study dug given as a single oral dose of 2.5 mg tablet in participants with liver impairment and healthy participants matched for age-, gender-, and weight.
The participants stayed at the trial site for about 5 days. During this time, the doctors took blood and urine samples and checked the participants' health. About 7 after the participants took vericiguat (BAY1021189), the researchers checked the participants' health again and asked about any medical problems they had.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Child Pugh A | Experimental | Drug: Vericiguat (BAY1021189)Participants with mild hepatic impairment |
| Child Pugh B | Experimental | Drug: Vericiguat (BAY1021189)Participants with moderate hepatic impairment |
| Healthy participants | Experimental | Drug: Vericiguat (BAY1021189)Participants with normal hepatic function |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Aged between 18 and 79 years (inclusive) with body mass index 18 to 34 kg/m^2 (both inclusive)
- Women without childbearing potential; women of childbearing potential only if the pregnancy test was negative and a combination of condoms with a safe and highly effective
- Subjects with documented liver cirrhosis confirmed by histopathology, e.g., previous liver biopsy, laparoscopy, ultrasound, or fibroscan
- Subjects with hepatic impairment (Child Pugh A or B)
- Subjects with stable liver disease in the last 2 months
Key exclusion criteria (26 listed)
- Subjects with a medical disorder, condition, or history of such that would impair the subject's ability to participate or complete this study in the opinion of the investigator or the sponsor
- Medical history of Kock pouch (ileostomy after proctocolectomy)
- 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 gastrointestinal (GI) disorders (eg stomach ulcers, duodenal ulcers, GI bleeding) or inflammatory bowel disease (eg Crohn's disease, ulcerative colitis)
- Febrile illness within 1 week prior to admission to study center
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 |
|---|---|---|
| Vericiguat (BAY1021189)Oral single dose of 2.5 mg (2 x 1.25 mg immediate release tablet) | Drug | Child Pugh A, Child Pugh B, Healthy participants |
Primary outcome
AUC of vericiguat
Time frame: Up to 96 hours
Area under the concentration vs. time curve from zero to infinity after single dose administration
AUCu of vericiguat
Time frame: Up to 96 hours
AUC unbound
Cmax of vericiguat
Time frame: Up to 96 hours
Maximum observed drug concentration in measured matrix after single dose administration
Cmax,u of vericiguat
Time frame: Up to 96 hours
Cmax unbound
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 25 Jan 2021.
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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.
Bayer Study Director study director
Bayer
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 Vericiguat (BAY1021189) 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 10 inclusion and 26 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 25 Jan 2021. 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 (time frame: Up to 96 hours). 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 25 Jan 2021.