Endometriosis
Conditions
Brief 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.
Interventions
DRUGBAY2328065 LSF
20 mg/mL LSF (liquid service formulation), orally
DRUGBAY2328065 tablet
50 mg tablet, orally
DRUGPlacebo LSF
Matching Placebo LSF, orally
DRUGPlacebo tablet
Matching Placebo tablet, orally
DRUGMidazolam
1 mg per day, orally
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Open-label crossover in bridging part; double-blind, parallel group in multiple dose escalation part
Intervention model description
The study will be performed in 2 study parts. Each participant will take part in one study part only. * Bridging part: This will be a single-center, randomized, open-label cross-over part with 3 study interventions, 3 intervention periods and 2 intervention sequences. * Multiple dose escalation part: This will be a single-center, randomized, placebo-controlled, double-blind, parallel group multiple dose escalation part.
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of subjects with treatment-emergent adverse events (TEAEs) | From first dosing up to 30 days after end of treatment with study intervention, summing up to approximately 39 to 45 days for a participant |
| Severity of TEAEs | From first dosing up to 30 days after end of treatment with study intervention, summing up to approximately 39 to 45 days for a participant |
| AUC(0-12)md (twice daily [BID]) | From first dose of BAY2328065 until 72 hour after the last dose of BAY2328065 |
| Cmax,md of BAY2328065 | From first dose of BAY2328065 until 72 hour after the last dose of BAY2328065 |
Countries
Germany
Outcome results
None listed