A Study in Healthy Adult Male Participants to Learn the Way Vericiguat is Absorbed With and Without Food When Taken as a Single Dose in Liquid Form Suitable for Children Compared to a 10 Milligram (mg) Tablet That Releases the Active Substance Immediately
Condition: Heart Failure; Children
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      Researchers are looking for a better way to treat heart failure, a condition in which the
      heart does not pump blood as well as it should. Heart failure can happen in both adults and
      children.

      The study treatment, vericiguat, is already available for doctors to give to adults who have
      heart failure. It works by increasing the activity of an enzyme called soluble guanylate
      cyclase (sGC). The sGC enzyme helps regulate the heart and blood circulation.

      The current form of vericiguat is a tablet that releases the "active substance" immediately.
      The "active substance" is the part of the drug that works in the body to treat the condition.
      Vericiguat is currently only available as a treatment for adults. Researchers think
      vericiguat could help treat children with heart failure, but think it will be easiest for
      them to take a liquid treatment.

      Another study is planned to find out how well vericiguat works in children who have a
      specific type of heart failure. Before researchers can give vericiguat to children, they must
      first study different doses and ways of taking vericiguat in adults. In this study, the
      researchers will study a new liquid form of vericiguat in adults. This form is also known as
      the "pediatric formulation".

      In this study, the researchers want to find out how the new pediatric formulation of
      vericiguat moves into, through, and out of the body compared to the currently approved tablet
      form for adults. The researchers also want to find out if eating food affects the new
      pediatric formulation differently than the current tablet form of vericiguat.

      The study will include about 36 healthy white male participants aged between 18 and 45 years
      old.

      During this study, the participants will all take 4 different treatments in different orders.
      They will take:

        -  a high dose of vericiguat in the new pediatric formulation, with food

        -  a high dose of vericiguat in the new pediatric formulation, without food

        -  a low dose of vericiguat in the new pediatric formulation, with food

        -  a dose of the currently available tablet form, with food While taking each study
           treatment, the participants will stay at the study site for 4 days. There will be a
           break of at least 10 days between each treatment. Overall, the participants will be in
           this study for about 11 weeks.

      During the study, the participants will:

        -  have blood and urine samples taken

        -  have their overall health and heart health checked

        -  answer questions about how the new pediatric formulation tastes

        -  answer questions about any 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): Vericiguat (BAY1021189) - Intervention A; Vericiguat (BAY1021189) - Intervention B; Vericiguat (BAY1021189) - Intervention C; Vericiguat (Verquvo, BAY1021189) - Intervention D
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Single dose of 10 mg vericiguat high-concentration pediatric formulation (oral liquid formulation) in fed state.; Single dose of 10 mg vericiguat high-concentration pediatric formulation (oral liquid formulation) in fasted state.; Single dose of 2.5 mg vericiguat low-concentration pediatric formulation (oral liquid formulation) in fed state.; Single dose of 10 mg vericiguat immediate release (IR) intact tablet in fed state.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science