Orlando Clinical Research Center | Orlando, FL
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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:
The study participants will be assigned to one of the four treatment groups based on their liver function:
Each participant will be in the study for around 5 to 6 weeks, which includes:
During the study, the doctors and their study team will:
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.
Enrollment
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Inclusion criteria
Participant must be 18 to 79 years (both inclusive) at the screening visit
Participants with hepatic impairment classified as Child-Pugh A or B
Participants who have normal hepatic function and are overtly healthy.
Body mass index (BMI): 18 to 36 kg/m*2 (both inclusive).
Male or female. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Male participants: Must agree to use contraception/barrier as detailed below:
Female participants: A female participant is eligible to participate if she is not pregnant or breast feeding, and one of the following conditions applies:
A WOCBP must have a negative highly sensitive pregnancy test within 24h before the first dose of study intervention.
Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
32 participants in 3 patient groups
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Central trial contact
Bayer Clinical Trials Contact
Data sourced from clinicaltrials.gov
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