Study to Test the Safety of Increasing Multiple Doses of BAY2328065 Given by Mouth, How the Drug is Tolerated and Acts in the Human Body of Healthy Male Participants. Alteration of the Study Drug Effects by Another Drug and the Availability of the D

• Status: Completed
• Trial end date: 2020-11-16
• Target enrollment: 0
• Participant gender: Male

Summary

Study on the safety and tolerability of a new drug BAY2328065 when given increased doses as tablet or solution over 12 days to healthy male participants. Researcher want to study how the body absorbs, breaks down and excrete the new drug, also when given together with a test meal. In addition the study will investigate changes that take place in the body when BAY2328065 is given together with another drug.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bayer
• Treatments: Midazolam

Criteria

Inclusion Criteria:

• Participant must be 18 to 50 years of age inclusive, at the time of signing the informed consent

• Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, ECG and vital signs

• Confirmation of the subject's health insurance coverage prior to the first screening examination/visit

• Body mass index (BMI) within the range 18 and 30 kg/m^2 (inclusive)

• Male participants who are sexually active must agree to use two reliable and acceptable methods of contraception simultaneously (one method used by the study participant and one method used by the partner) and not to act as sperm donor until follow-up

• Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol

• The informed consent must be signed before any study specific tests or procedures are done

• Ability to understand and follow study-related instructions

Exclusion Criteria:

• Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study intervention will not be normal

• Relevant diseases within the last 4 weeks prior to start of the first study intervention

• Known severe allergies, non-allergic drug reactions, or multiple drug allergies

• Existing chronic diseases requiring medication

• History of cardiovascular disease

• Known diseases as specified in protocol

• Regular use of therapeutic or recreational drugs

• Suspicion of drug or alcohol abuse

• Smoking equal or more than 10 cigarettes/day

• Clinically relevant findings in Electrocardiogram (ECG), blood pressure, heart rate, physical examination, laboratory examination

• History of COVID-19

• Contact with SARS-CoV-2 positive persons or COVID-19 patients within the last 4 weeks prior admission to the ward

• Positive SARS-CoV-2 viral RNA test