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
Condition: Chronic Kidney Disease; Healthy Volunteers
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 1

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)
    


Intervention name(s): BAY3283142; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Oral administration as tablet.; Oral administration as tablet.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science