A Trial to Learn How BAY1834845 and BAY1830839 Affect Inflammation When Taken by Mouth Twice a Day for 7 Days in a Row in Healthy Male Participants
Condition: Immune Mediated Inflammatory Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The immune system helps protect the body from diseases. But, sometimes the immune system can
      be too sensitive and overreact to very small allergens, like dust and pet dander. This can
      cause skin conditions like dermatitis and eczema. People with these skin conditions have
      inflammation that can cause dry, red, and itchy skin. These symptoms often "flare up",
      meaning that the symptoms come back after being gone for some time.

      Researchers are looking for a different way to treat people who have skin conditions caused
      by an overreaction of the immune system. Before a treatment is available to all patients,
      researchers study it in trials to better understand its safety and how well it works.

      In this trial, the researchers will learn more about how BAY1834845 and BAY1830839 work and
      how safe they are in healthy male participants.

      The trial will include about 72 healthy male participants who are between the ages of 18 and
      55.

      The researchers will use a computer program to randomly choose the treatment each participant
      will take. This will help make sure the treatments are chosen fairly. Researchers do this so
      that comparing the results of the treatments is accurate as possible. The participants will
      be randomly put into 1 of 4 groups. The participants will take their trial treatment 2 times
      a day for 7 days in a row.

        -  Group 1: BAY1834845 as tablets by mouth

        -  Group 2: BAY1830839 as tablets by mouth

        -  Group 3: A placebo as tablets by mouth

        -  Group 4: Prednisolone as tablets by mouth A placebo looks like a treatment but does not
           have any medicine in it. Prednisolone is a steroid treatment that is already available
           for doctors to prescribe to people with skin conditions caused by an overreaction of the
           immune system.

      All the participants will also receive imiquimod applied as a cream to their back. All
      participants will also receive lipopolysaccharide as an intravenous infusion. Imiquimod and
      lipopolysaccharide will be used to cause irritation and inflammation of the skin and in the
      blood. The researchers want to see if treatment with BAY1834845 and BAY1830939 can then help
      reduce these symptoms of irritation and inflammation.

      In this trial, the researchers will look at:

        -  the change in the amount of blood flow in the participants after imiquimod

        -  the change in how red the participants' skin is after imiquimod

        -  the change in the amount of inflammation applying the participants have after receiving
           lipopolysaccharide infusion
    


Intervention name(s): BAY1834845; BAY1830839; Prednisolone; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Tablet, oral.; Tablet, oral.; Tablet, oral.; Tablet, oral.
Intervention MeSH terms: Prednisolone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science