This study is a first in human study that will investigate the safety, tolerability and pharmacokinetics of ascending single doses of BAY1817080 using a placebo controlled, randomized, single center design. In addition the influence of itraconazole and food on the pharmacokinetics of BAY1817080 will be investigated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
88
Study part 1: Escalating doses of BAY1817080; single dose administration; solid dosage form (redosing of BAY1817080 at dose group 1 and 2 together with itraconazole; redosing of BAY1817080 at dose group 4 together with food \[American breakfast\]) Study part 2: Escalating doses of BAY1817080; single dose administration together with an American breakfast; solid dosage form (redosing of BAY1817080 at dose group 1, 2 and 4 together with food \[Continental breakfast\])
Study part 1: Escalating doses of respective placebos; single dose administration; solid dosage form (redosing of placebo at dose group 1 and 2 together with itraconazole; redosing of placebo at dose group 4 together with food \[American breakfast\]) Study part 2: Escalating doses of respective placebos; single dose administration together with an American breakfast; solid dosage form (redosing of placebo at dose group 1, 2 and together with food \[Continental breakfast\])
CRS Clinical Research Services Berlin GmbH
Berlin, Germany
Frequency of treatment-emergent adverse events
Time frame: Up to 4 months
Severity of treatment-emergent adverse events
Time frame: Up to 4 months
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Redosing of BAY1817080/placebo at dose group 1 and 2 together with itraconazole (study part 1)