A Study to Learn How the Study Treatment BAY3283142 Taken as Single Dose by Mouth Moves Into, Through, and Out of the Body, How Safe it is, and How it Affects the Body in Participants With Reduced Kidney Function Compared to Participants With Normal Kidney Function of Similar Age, Gender, and Weight
Condition: Chronic Kidney Disease; Renal Impairment; Healthy Volunteers
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency
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 filter the blood properly. High blood
      pressure makes it more likely that the CKD gets worse.

      The study treatment BAY3283142 is under development for treating CKD. It activates 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 do not benefit from this study. However, the study will provide information
      on how to use BAY3283142 in subsequent studies in people with CKD.

      In previous studies, BAY3283142 was studied in participants with normal kidney function. As
      kidneys play a role in removal of drugs from the body, the degree of kidney function could
      influence the amount of BAY3283142 in the blood. Higher amounts may occur in people with
      reduced kidney function.

      Therefore, the main purpose of this study is to learn how the study treatment BAY3283142
      moves into, through, and out of the body in participants with mild to severe reduction of
      kidney function compared to matched participants with normal kidney function.

      To answer this, the researchers will compare:

        -  the (average) total level of BAY3283142 in the blood (also called AUC).

        -  the (average) highest level of BAY3283142 in the blood (also called cmax) between the
           different groups. Participants will be in one of four groups based on how much their
           kidney function is reduced (mild, moderate, severe, end stage kidney disease) or in the
           control group.

      All participants will take a single dose of BAY3283142 as tablet by mouth. Each participant
      will be in the study for approximately 4 weeks including an in-house stay of 6 days (with 5
      overnight stays). In addition, a screening visit to the study site before the in-house stay
      is planned.

      During the study, the study team will:

        -  check vital signs

        -  do physical examinations

        -  take blood and urine samples

        -  examine 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 that happen in studies, even if they do not think the adverse
      events might be related to the study treatments.
    


Intervention name(s): Single oral dose of BAY3283142 IR (immediate release) tablet
Intervention type(s): Drug
Intervention description(s): Single oral dose of BAY3283142 in participants with renal impairment compared to an age, gender and weight matched control group in an open-label study design
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment