Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06402721
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-05-03
Brief Title:
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
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 participants 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
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 participants 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None