A Study to Learn How Safe the Study Treatment BAY2395840 is, How it Affects the Body and How it Moves Into, Through, and Out of the Body if Given in Single and in Repetitive Doses to Japanese Healthy Male Participants
Condition: Diabetic Neuropathic Pain; Healthy Volunteers
MeSH terms: Neuralgia
Study type: Interventional
Phase: Phase 1

Summary: 
      Researchers are looking for a better way to treat people who have diabetic neuropathic pain
      (DNP).

      DNP is pain due to damage to the nerves in the extremities that can occur in patients with
      diabetes as a result of blood sugar levels being too high for too long.

      BAY2395840 works by blocking specific receptors. A receptor is a protein inside or on the
      surface of a cell that binds to a specific substance and causes a specific effect in the
      cell. BAY2395840 specifically blocks so-called bradykinin B1 receptor, whose activation is
      involved in inflammatory responses. This blockage may help to relieve pain and inflammation.

      BAY2395840 has already been studied in clinical studies with European people. However, data
      for Japanese people are still missing. The participants of this study do not benefit from
      this study. However, the study will provide information on how to use BAY2395840 in later
      studies with Japanese people.

      The main purpose of this study is to learn how safe the study drug BAY2395840 is and how it
      affects the body if given in single and in repetitive doses to Japanese healthy male
      participants.

      To answer this question, the researchers will collect and analyze the medical problems the
      participants have after taking BAY2395840 and that may or may not be related to the study
      treatments. These medical problems are also known as "adverse events".

      In addition, the study team will learn how BAY2395840 moves into, through and out of the body
      if given in single and in repetitive doses to Japanese healthy male participants. For this,
      the researchers will collect data on:

        -  the (average) highest level of BAY2395840 in the blood (also referred to as Cmax)

        -  the (average) total level of BAY2395840 in the blood (also referred to as AUC) during
           the treatment period with the study drug on day 1 and for the repetitive dose group only
           (see below), on day 7.

      Subsequently, the study team will compare the data between those participants who received
      the study drug BAY2395840 (from different dosing groups) and those participants who received
      placebo. A placebo is a treatment that looks like a medicine but does not have any medicine
      in it.

      All study participants will be randomly (by chance) assigned to 1 of 5 treatment groups.
      Dependent on the treatment group, the participants will either take:

        -  a single dose of the lowest, middle and highest BAY2395840 dose (treatment groups 1 to
           3)

        -  repetitive doses of the highest BAY2395840 dose (treatment group 4) or

        -  placebo (treatment group 5).

      The participants will take their treatments as dosage form 1 after diet 1. The treatment
      period with repetitive doses of BAY2395840 will be 7 subsequent days.

      The participants from treatment groups 1 to 3 will have an in house-period of 8 days
      including 7 overnight stays. The participants from treatment group 4 will have an in
      house-period of 12 days including 11 overnight stays. The study duration will be
      approximately 6 weeks per participant for dose groups 1 to 3 and approximately 7 weeks per
      participant for dose group 4.

      During the study, the study team will:

        -  take blood and urine samples

        -  do physical examinations

        -  check the vital signs such as blood pressure, heart rate, body temperature

        -  examine heart health using electrocardiogram (ECG).

      About 10 to 14 days after the participants take their last treatment, the study doctors and
      their team will check the participants' health.
    


Intervention name(s): BAY2395840
Intervention type(s): Drug
Intervention description(s): Administration of dosage form 1 under diet 1 condition
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Single (Participant)
Primary purpose: Other