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 Drug Given in Different Formulations is Also Tested.
Status and phase
Completed
Phase 1
Conditions
Endometriosis
Treatments
Drug: Placebo tablet
Drug: Placebo LSF
Drug: BAY2328065 LSF
Drug: Midazolam
Drug: BAY2328065 tablet
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
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.
Enrollment
50 patients
Sex
Male
Ages
18 to 50 years old
Volunteers
Accepts Healthy Volunteers
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
Trial design
Primary purpose
Basic Science
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Quadruple Blind
50 participants in 6 patient groups
Bridging part: intervention sequence ABC or BAC
Experimental group
Description:
10 healthy male participants will be randomly allocated to this arm. The study interventions will follow the sequence ABC or BAC: A: single dose of 50 mg BAY2328065 given as LSF in fasted state B: single dose of 50 mg BAY2328065 given as tablet in fasted state C: single dose of 50 mg BAY2328065 given as tablet in fed state (i.e. after a high caloric and high fat meal)
Treatment:
Drug: BAY2328065 tablet
Drug: BAY2328065 LSF
Multiple dose escalation part: dose 1
Experimental group
Description:
10 participants will be randomly allocated to active drug or placebo (8 active drug, 2 placebo).
The study intervention will be administered with a single dose on the first dosing day followed by twice daily doses for 10 days followed by a single dose on the last dosing day
Treatment:
Drug: Placebo LSF
Drug: BAY2328065 LSF
Multiple dose escalation part: dose 2
Experimental group
Description:
10 participants will be randomly allocated to active drug or placebo (8 active drug, 2 placebo).
The study intervention will be administered with a single dose on the first dosing day followed by twice daily doses for 10 days followed by a single dose on the last dosing day Midazolam is given for investigation of drug-drug interaction
Treatment:
Drug: BAY2328065 tablet
Drug: Midazolam
Drug: Placebo tablet
Multiple dose escalation part: dose 3
Experimental group
Description:
10 participants will be randomly allocated to active drug or placebo (8 active drug, 2 placebo).
The study intervention will be administered with a single dose on the first dosing day followed by twice daily doses for 10 days followed by a single dose on the last dosing day Midazolam is given for investigation of drug-drug interaction
Treatment:
Drug: BAY2328065 tablet
Drug: Midazolam
Drug: Placebo tablet
Multiple dose escalation part: dose 4
Experimental group
Description:
10 participants will be randomly allocated to active drug or placebo (8 active drug, 2 placebo).
The study intervention will be administered with a single dose on the first dosing day followed by twice daily doses for 10 days followed by a single dose on the last dosing day Midazolam is given for investigation of drug-drug interaction
Treatment:
Drug: BAY2328065 tablet
Drug: Midazolam
Drug: Placebo tablet
Multiple dose escalation part: dose 5
Experimental group
Description:
10 participants will be randomly allocated to active drug or placebo (8 active drug, 2 placebo).
The study intervention will be administered with a single dose on the first dosing day followed by a treatment pause of 2 days followed by twice daily doses for 1 day followed by three times daily doses for 9 days followed by a single dose on the last dosing day Midazolam is given for investigation of drug-drug interaction
Treatment:
Drug: BAY2328065 tablet
Drug: Midazolam
Drug: Placebo tablet
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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