A Study to Learn How Safe the Study Treatment BAY3283142 is, How it Affects the Body, How it Moves Into, Through and Out of the Body When Single and Multiple Amounts Are Taken as Tablets in Japanese Healthy Male Participants

Healthy Volunteers Clinical Trial

Official title: Single and Multiple Dose Escalation Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BAY 3283142 Given as Oral Tablets in Japanese Healthy Male Participants in a Randomized, Placebo-controlled, Single-blind, Group Comparison Design

Status Completed

Clinical Trial Summary

Researchers are looking for a better way to treat people who have chronic kidney disease (CKD).

The kidneys filter extra water and waste out of the blood and make urine. CKD is a long-term, progressive decrease in the kidneys' ability to work properly.

The study treatment BAY3283142 is under development for treating 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.

The participants of this study will be healthy and will have no benefit from the intake of the study treatment. However, the study will provide information on how to use BAY3283142 in subsequent studies in people with CKD.

The main purpose of this study is to learn how safe the study treatment BAY3283142 is and how it affects the body in comparison to placebo when given as single and multiple amounts in healthy male participants in Japan. A placebo is a treatment that looks like a medicine but does not have any medicine in it.

To do this, the study team will compare the number of participants who have medical problems after taking BAY3283142 with those participants who take placebo. These medical problems are called adverse events. The study doctors and their team keep track of all medical problems that happen in studies, even if they do not think they might be related to the study treatments.

Another purpose of this study is to learn how the study treatment BAY3283142 moves into, through, and out of the body. To answer this, the study doctors and their team will take blood samples from the participants and measure:

• The average highest level of BAY3283142 in the blood (also called Cmax)

• The average total level of BAY3283142 in the blood (also called AUC).

Dependent on the treatment group, the participants will either take BAY3283142 or placebo as tablet once a day. A group of participants will start out by receiving a low amount of the study treatment. The study doctors will look at the results from these participants and then decide whether to increase the amount of the study treatment in the next group of participants. Researchers use dose escalation studies to learn about the safety of a specific amount before participants are given a higher amount.

Participants will be in the study for up to 7 weeks, including an in-house stay of up to 15 days. One test (screening) visit to the study center is planned before the start of treatment and one follow-up visit is planned after the end of treatment.

During the study, the study team will:

• check vital signs

• do physical examinations

• take blood and urine samples

• examine the participants' heart health using electrocardiogram (ECG)

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Healthy Volunteers
• Kidney Diseases
• Renal Insufficiency, Chronic

• NCT number: NCT05800444
• Study type: Interventional
• Source: Bayer
• Status: Completed
• Phase: Phase 1
• Start date: April 3, 2023
• Completion date: July 19, 2023