BAY3283142 for Chronic Kidney Disease

Overseen By Bayer Clinical Trials Contact

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Bayer

Disqualifiers: Severe ascites, Hepatic encephalopathy, Renal failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

Duration: 1 week

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Researchers are looking for a better way to treat people who have chronic kidney disease (CKD). CKD is a condition in which the kidneys' ability to work properly gradually decreases over time. The kidneys help the body get rid of waste through urine and filter the blood before sending it back to the heart. When kidney function decreases, waste builds up in the body, which can cause various complications. The study treatment, BAY 3283142, is under development to treat CKD. It works by activating a protein called soluble guanylate cyclase (sGC) that generates cGMP - a molecule that relaxes blood vessels and is thought to have beneficial effects in CKD. BAY3283142 is broken down in the liver by a specific enzyme before it is removed from the body. In this study, researchers want to understand how a mild or moderate reduction in liver function affects the blood levels of BAY3283142. The main purpose of this study is to learn how BAY3283142 moves into, through, and out of the body, after a single dose of BAY3283142 in participants with reduced liver function. For this, the researchers will analyze: * Area under the curve (AUC): a measure of the total amount of BAY3283142 in participants' blood over time * Maximum observed concentration (Cmax): the highest amount of BAY 3283142 in participants' blood The AUC and Cmax values for participants with reduced liver function will be compared with the values for participants with normal liver function. The study participants will be assigned to one of the four treatment groups based on their liver function: * Group 1: participants with mild reduction in liver function * Group 2: participants with moderate reduction in liver function * Groups 3 and 4: participants with normal liver function who will be matched for age, weight, and gender with participants with reduced liver function All participants will take a single dose of BAY3283142 as a tablet by mouth without food. Each participant will be in the study for around 5 to 6 weeks, which includes: * a visit within 28 days of starting treatment to confirm if the participant can take part in this study * a hospital stay for 7 days during which the participant will be given a single dose of BAY3283142 and the study doctor will monitor the participant's health * a visit after 7 to 10 days of taking BAY3283142 during which the study doctor will perform a health check-up on the participant During the study, the doctors and their study team will: * check participants' health by performing tests such as blood and urine tests, blood pressure measurements, and checking heart health using an electrocardiogram (ECG) * ask the participants 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 of whether they think it is related or not to the study treatment. Access to study treatment after the end of this study is not planned. Participants with liver problems can continue taking their other prescribed medicines as usual.

Are You a Good Fit for This Trial?

This trial is for adults aged 18-79 with chronic kidney disease and confirmed liver problems (mild to moderate), who are not pregnant, agree to use contraception, have stable liver disease, a BMI of 18-36 kg/m2, and can be either gender. Those with severe liver issues or other health conditions that could interfere with the study are excluded.

Inclusion Criteria

My liver functions normally and I am generally healthy.

I agree to use a condom and understand the benefits of my partner using contraception.

My disease was confirmed with a biopsy or imaging test.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person)

Treatment

Participants receive a single dose of BAY3283142 and are monitored for pharmacokinetics, safety, and tolerability

1 week

7-day hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• BAY3283142

Trial Overview The study tests BAY3283142's effects on people with reduced liver function. It measures how the drug moves into, through, and out of the body after one dose by comparing blood levels in those with mild or moderate liver impairment against those with normal function.

How Is the Trial Designed?

Group I: Group 3 and 4: Normal hepatic function (control group) Experimental Treatment 1 Intervention

Control group(s) of age-, weight-, and gender-matched participants with normal hepatic function.

Group II: Group 2: Moderate hepatic impairment Experimental Treatment 1 Intervention

Participants with moderate hepatic impairment.

Group III: Group 1: Mild hepatic impairment Experimental Treatment 1 Intervention

Participants with mild hepatic impairment.

Who Is Running the Clinical Trial?

Bayer

Lead Sponsor

Trials

2,291

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25,560,000+

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1863

Headquarters

Leverkusen, Germany

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Bill Anderson

Bayer

Chief Executive Officer since 2023

BSc in Chemical Engineering from the University of Texas, MSc in Chemical Engineering and Management from MIT

Michael Devoy

Bayer

Chief Medical Officer since 2014

MD, PhD