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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
50
20 mg/mL LSF (liquid service formulation), orally
50 mg tablet, orally
Matching Placebo LSF, orally
Matching Placebo tablet, orally
1 mg per day, orally
CRS Clinical Research Services Berlin GmbH
Berlin, Germany
Number of subjects with treatment-emergent adverse events (TEAEs)
Time frame: 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
Time frame: 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])
Time frame: From first dose of BAY2328065 until 72 hour after the last dose of BAY2328065
Cmax,md of BAY2328065
Time frame: From first dose of BAY2328065 until 72 hour after the last dose of BAY2328065
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.