This study will be conducted in a single center, double-blind with 6 dose escalation groups to evaluate the safety, tolerability, and pharmacokinetics of single ascending doses of BAY1161116.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
32
Escalating doses of BAY1161116; single dose administration; redosing of BAY1161116 at dose group 1 together with itraconazole; redosing of BAY1161116 at dose group 2 as liquid service formulation, redosing of BAY1161116 at dose group 3 together with food
Escalating doses of respective placebos; single dose administration; redosing of placebo at dose group 1 together with itraconazole; redosing of placebo at dose group 2 as liquid service formulation, redosing of placebo at dose group 3 together with food
Redosing of BAY1161116/placebo at dose group 1 together with itraconazole
CRS Clinical Research Services Berlin GmbH
Berlin, Germany
Incidence of TEAEs
TEAEs: treatment-emergent adverse events
Time frame: 5 weeks
Severity of TEAEs
TEAEs: treatment-emergent adverse events
Time frame: 5 weeks
AUC of BAY1161116
AUC: Area under the concentration vs. time curve from zero to infinity
Time frame: 5 weeks
Cmax of BAY1161116
Cmax: maximum observed drug concentration
Time frame: 5 weeks
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