A Study in Male and Female Participants (After Menopause) With Mild to Moderate High Blood Pressure to Learn How Safe the Study Treatment BAY3283142 is, How it Affects the Body and How it Moves Into, Through and Out of the Body After Taking Single and Multiple Doses
Condition: Chronic Kidney Disease; Hypertension
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      Researchers are looking for a better way to treat people who have chronic kidney disease
      (CKD), a progressive decrease in the kidneys' ability to work properly.

      In people with CKD, the kidneys do not remove wastes and extra fluid from the blood as well
      as they should. 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. As many people with CKD do
      also suffer from high blood pressure, this study is done in people with mild to moderate high
      blood pressure to safeguard the use of BAY3283142 in people with CKD in later studies.

      The main purpose of this study is to learn how safe different single and multiple doses of
      the study treatment BAY3283142 are compared to placebo in male and female participants (after
      menopause) with mild to moderate high blood pressure. A placebo is a treatment that looks
      like a medicine but does not have any medicine in it.

      To answer this, the researchers will compare the number of participants who have medical
      problems after taking BAY3283142 to those treated with placebo. Doctors keep track of all
      medical problems that happen in studies, even if they do not think they might be related to
      the study treatments.

      Dependent on the treatment group, the participants will either take BAY3283142 or placebo as
      tablet once or twice a day. Patients will take one dose for 6 days and will then be switched
      to a higher dose for additional 6 days. In summary, three different dose combinations
      consisting of two different doses each will be tested.

      Participants will be in the study for up to 7 weeks, including 12 treatment days (6 per dose
      step). They will stay in-house for 17 days starting two days before intake of the study
      treatment. In addition, one visit before and one visit after the in-house phase to the study
      site is planned.

      During the study, the study team will:

        -  Check vital signs

        -  Take blood and urine samples

        -  Examine the participants' heart health using electrocardiogram (ECG)
    


Intervention name(s): BAY3283142; Placebo to BAY3283142
Intervention type(s): Drug; Drug
Intervention description(s): Oral administration; Oral administration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment