check_circleStudy Completed

Chronic kidney disease, Hepatic impairment

A Study to Learn About How BAY 3283142 Moves Into, Through, and Out of the Body After a Single Dose in Participants With Reduced Liver Function Compared to Participants With Normal Liver Function

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

18 - 79 Years

Trial summary

Enrollment Goal
24
Trial Dates
May 2024 - February 2025
Phase
Phase 1
Could I Receive a placebo
No
Products
BAY3283142
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Orlando Clinical Research Center (OCRC)Orlando, 32809-3017, United States

Primary Outcome

  • Area under the curve (AUC) of BAY3283142
    AUC(0-tlast) will be used as main parameter, if mean AUC cannot be reliably determined in all participants.
    date_rangeTime Frame:
    On Day 1 (dosing day), Day 2, Day 3, Day 4, Day 5, and Day 6.
  • Maximum observed drug concentration (Cmax) of BAY3283142
    date_rangeTime Frame:
    On Day 1 (dosing day), Day 2, Day 3, Day 4, Day 5, and Day 6.

Secondary Outcome

  • Number of participants with treatment-emergent adverse events
    date_rangeTime Frame:
    7 days after last administration of study drug

Trial design

An open-label study to evaluate the pharmacokinetics, safety and tolerability of BAY 3283142 in participants with impaired hepatic function (classified as Child-Pugh A or B) in comparison to matched controls with normal hepatic function
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
Non-randomized
Blinding
N/A
Assignment
Parallel Assignment
Trial Arms
3