Ignite Creation Date:
2024-07-17 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06487845
Status:
COMPLETED
Last Update Posted:
2024-07-05
First Post:
2024-06-24
Brief Title:
A Study to Learn How Safe BAY3283142 is When Taken as a Single Dose or as Multiple Doses in Healthy Chinese Participants
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official Title:
Single and Multiple Dose Escalation Study to Investigate Safety Tolerability Pharmacokinetics and Pharmacodynamics of BAY 3283142 Given as Immediate Release IR Tablets in Chinese Healthy Participants in a Randomized Placebo-controlled Single-blind Group-comparison Design
Status:
COMPLETED
Status Verified Date:
2024-09
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 or non-proliferative diabetes retinopathy NPDR CKD is a long-term condition in which the ability of the kidneys to work decreases over time It is often caused by high blood glucose levels NPDR is another condition in which high blood glucose levels cause damage to the blood vessels of the retina which is a tissue at the back of the eyes
The study drug BAY3283142 works by activating a protein called soluble guanylate cyclase which helps widen the blood vessels and regulate blood flow inside the body This may help increase the blood flow in the kidneys and improve their function It could also help to restore blood flow to the retina
This study will include healthy participants who will not benefit from taking BAY3283142 However the study will provide information on how to test BAY3283142 in future studies in participants with CKD or NPDR
The main purpose of this study is to check how safe single and multiple doses of BAY3283142 are in healthy Chinese participants
For this researchers will collect the number and percentage of participants who have medical problems which are also known as adverse events after taking BAY3283142 or a placebo A placebo looks like the study treatment but does not have any medicine in it
The study doctor will keep track of all adverse events that happen in the study even if they are not related to the study treatments
The participants will be randomly divided into 2 treatment groups They will take either BAY3283142 as an immediate-release tablet or a placebo tablet once by mouth based on the group assigned to them An immediate-release tablet quickly dissolves and releases the drug inside the body
Participants will have a one-day break after taking the single dose and then continue taking their assigned treatment once daily for a week Researchers will check two different dose strengths of BAY3283142 in this study starting with a low dose first
Each participant will be in the study for around 7 weeks which includes
A visit within 21 days before the first dose to confirm if the participant can take part in the study
A hospital stay of 15 days during which the participant will take the assigned study treatment and the study doctor will monitor the participants health
A visit after 7 to 10 days of taking the last dose during which the study doctor will perform a health check-up of the participant
During the study the study doctor and hisher team will
Test participants blood and urine samples and check their overall health
Monitor participants heart health by electrocardiogram ECG and measure their blood pressure and heart rate
As this study is conducted in healthy participants who will not gain any benefit from the treatment access to the treatment after the study is not planned
The study drug BAY3283142 works by activating a protein called soluble guanylate cyclase which helps widen the blood vessels and regulate blood flow inside the body This may help increase the blood flow in the kidneys and improve their function It could also help to restore blood flow to the retina
This study will include healthy participants who will not benefit from taking BAY3283142 However the study will provide information on how to test BAY3283142 in future studies in participants with CKD or NPDR
The main purpose of this study is to check how safe single and multiple doses of BAY3283142 are in healthy Chinese participants
For this researchers will collect the number and percentage of participants who have medical problems which are also known as adverse events after taking BAY3283142 or a placebo A placebo looks like the study treatment but does not have any medicine in it
The study doctor will keep track of all adverse events that happen in the study even if they are not related to the study treatments
The participants will be randomly divided into 2 treatment groups They will take either BAY3283142 as an immediate-release tablet or a placebo tablet once by mouth based on the group assigned to them An immediate-release tablet quickly dissolves and releases the drug inside the body
Participants will have a one-day break after taking the single dose and then continue taking their assigned treatment once daily for a week Researchers will check two different dose strengths of BAY3283142 in this study starting with a low dose first
Each participant will be in the study for around 7 weeks which includes
A visit within 21 days before the first dose to confirm if the participant can take part in the study
A hospital stay of 15 days during which the participant will take the assigned study treatment and the study doctor will monitor the participants health
A visit after 7 to 10 days of taking the last dose during which the study doctor will perform a health check-up of the participant
During the study the study doctor and hisher team will
Test participants blood and urine samples and check their overall health
Monitor participants heart health by electrocardiogram ECG and measure their blood pressure and heart rate
As this study is conducted in healthy participants who will not gain any benefit from the treatment access to the treatment after the study is not planned
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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