A Trial to Learn What Happens to Different Medicinal Forms of BAY2328065 When They Enter the Body and How Safe They Are in Healthy Male and Female Participants
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Researchers are looking for a different way to treat women with a condition in which tissue
      that normally lines the uterus grows outside the uterus. This condition is called
      endometriosis. Before a treatment is available to all patients, researchers study it in
      clinical trials to better understand its safety and what happens to it in the body.

      BAY2328065 is being developed to help treat women who have endometriosis. Women with
      endometriosis often have very painful menstrual periods, as well as pain in the pelvic area
      which is not related to menstrual periods and pain during intercourse. Many women with
      endometriosis may also have problems becoming pregnant. The trial treatment, BAY2328065,
      works by blocking a certain protein that causes pain and swelling of the tissue and is
      thought to play a role in endometriosis.

      In this trial, the researchers want to compare what happens to different medicinal forms of
      BAY2328065 in the body. They also want to learn if eating a meal affects what happens to
      BAY2328065 in the body.

      This trial will include about 32 men and women who are aged 18 to 55. There will be 4 groups
      of participants in this trial. The participants in Groups 1, 2, and 3 will be men. The
      participants in Group 4 will be women. There will be 3 treatment courses to the trial for
      Groups 1, 2 and 3 and 1 treatment course for Group 4.

      During the trial, the participants in Groups 1, 2, and 3 will stay at the trial site for 15
      days (3 times 5 days with times in between during which they stay at home). The participants
      in Group 4 will stay at the trial site for 16 days continuously. But, the trial will last
      about 6 weeks for the participants in Groups 1, 2, and 3. The trial will last about 9 weeks
      for the participants in Group 4.

      All of the participants in Groups 1 and 2 will take the different medicinal forms of
      BAY2328065, with and without food. All of the participants in Groups 1 and 2 will take dose
      "2" of BAY2328065 in all 3 treatment courses. In Group 1, they will take BAY2328065 one time
      each during the following treatment courses:

        -  A medicinal form of BAY2328065 without food in treatment course 1, then

        -  A medicinal form of BAY2328065 differing from the one used in treatment course 1 without
           food in treatment course 2, then

        -  The medicinal form of BAY2328065 used in treatment course 1 with food in treatment
           course 3 The participants in Group 2 will do the same, but they will take each form of
           BAY2328065 in a different order. Information gathered from Group 1 and 2 will help the
           researchers learn which form of BAY2328065 will be most suited to give to the
           participants in Groups 3 and 4.

      The participants in Group 3 will take 3 different doses of BAY2328065 with food in each
      treatment course. They will take one time each during the following treatment courses:

        -  Single administration of dose "1" in treatment course 1, then

        -  Single administration of dose "2" in treatment course 2, then

        -  Single administration of dose "3" in treatment course 3 This will help the researchers
           learn the safest dose to give to the participants in treatment course 4.

      The participants in Group 4 will either take dose "3" or "2" of BAY2328065 based on the
      results of treatment course 3, or a placebo. A placebo looks like a treatment but does not
      have any medicine in it. All of the participants will take either:

        -  Multiple administrations of dose "3" of BAY2328065 or dose "2" of BAY2328065, OR

        -  the placebo The participants will take BAY2328065 or placebo over 12 days without food.

      The doctors/ healthcare staff will:

        -  take blood and collect urine samples

        -  check the participants' heart health

      The participants will:

        -  answer questions about how they are feeling

        -  say if they have any medical problems

        -  say if they have taken any medications
    


Intervention name(s): BAY2328065; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Solid Form, Oral administration.; Matching placebo of BAY2328065.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Study Groups 1 and 2 using a fixed sequence parallel group design
Study Group 3 using a fixed sequence design
Study Group 4 using a placebo-controlled parallel design
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment