The aim of this study is to investigate safety, tolerability and pharmacokinetics of increasing repeated oral doses of BAY1830839 in healthy male participants including the investigation of any potential drug-drug interactions of BAY1830839 with midazolam and methotrexate. In addition, the effects of BAY180839 on exploratory pharmacodynamics biomarkers in healthy participants will be investigated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
67
Tablet, oral.
Tablet, oral.
For all dose steps. Oral. Two single doses. One dose administered during pre-dose in Period 1 and the second dose administered on the last day of treatment with BAY1830839 or placebo in Period 2
Charité Research Organisation GmbH
Berlin, Germany
Frequency of TEAEs
TEAE: treatment-emergent adverse event
Time frame: 7 days (period 1)
Frequency of TEAEs
Time frame: 18 days (period 2)
Severity of TEAEs
Time frame: 7 days (period 1)
Severity of TEAEs
Time frame: 18 days (period 2)
AUC(0-24)md of BAY1830839 (QD and TID dosing)
QD:once daily administration TID: three times daily administration
Time frame: Day 1 period 1
AUC(0-12)md of BAY1830839 (BID dosing only)
BID:twice daily administration
Time frame: Day 1 period 2
Cmax,md of BAY1830839 after multiple dosing
Time frame: 18 days (period 2)
Cav of BAY1830839 after multiple dosing
Time frame: 18 days (period 2)
AUC of midazolam in plasma in presence/absence of BAY1830839
If AUC(tlast-∞) \>20% of AUC then AUC(0-tlast) will replace AUC.
Time frame: Day -1 period 1
Cmax of midazolam in plasma in presence/absence of BAY1830839
Time frame: Day -1 period 1
AUC of methotrexate in plasma in presence/absence of BAY1830839
If AUC(tlast-∞) \>20% of AUC then AUC(0-tlast) will replace AUC.
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Only for Dose 3 step. Tablet, oral. Two single doses. One dose administered during pre-dose in Period 1 and the second dose administered on the last day of treatment with BAY1830839 or placebo in Period 2.
Time frame: Day -1 period 1 (Dose group 3 of BAY1830839 only)
Cmax of methotrexate in plasma in presence/absence of BAY1830839
Time frame: Day -1 period 1 (Dose group 3 of BAY1830839 only)