check_circleStudy Completed
Healthy volunteers
Bayer Identifier:
19401
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Study to investigate safety, tolerability, pharmacokinetics, and drug-drug interaction of multiple oral doses of BAY1830839 in healthy male participants
Trial purpose
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.
Key Participants Requirements
Sex
MaleAge
18 - 50 YearsTrial summary
Enrollment Goal
67Trial Dates
June 2019 - May 2022Phase
Phase 1Could I Receive a placebo
YesProducts
BAY1830839Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Charité Research Organisation GmbH | Berlin, 10117, Germany |
Primary Outcome
- Frequency of TEAEsTEAE: treatment-emergent adverse eventdate_rangeTime Frame:7 days (period 1)
- Frequency of TEAEsdate_rangeTime Frame:18 days (period 2)
- Severity of TEAEsdate_rangeTime Frame:7 days (period 1)
- Severity of TEAEsdate_rangeTime Frame:18 days (period 2)
- AUC(0-24)md of BAY1830839 (QD and TID dosing)QD:once daily administration TID: three times daily administrationdate_rangeTime Frame:Day 1 period 1
- AUC(0-12)md of BAY1830839 (BID dosing only)BID:twice daily administrationdate_rangeTime Frame:Day 1 period 2
- Cmax,md of BAY1830839 after multiple dosingdate_rangeTime Frame:18 days (period 2)
- Cav of BAY1830839 after multiple dosingdate_rangeTime Frame:18 days (period 2)
- AUC of midazolam in plasma in presence/absence of BAY1830839If AUC(tlast-∞) >20% of AUC then AUC(0-tlast) will replace AUC.date_rangeTime Frame:Day -1 period 1
- Cmax of midazolam in plasma in presence/absence of BAY1830839date_rangeTime Frame:Day -1 period 1
- AUC of methotrexate in plasma in presence/absence of BAY1830839If AUC(tlast-∞) >20% of AUC then AUC(0-tlast) will replace AUC.date_rangeTime Frame:Day -1 period 1 (Dose group 3 of BAY1830839 only)
- Cmax of methotrexate in plasma in presence/absence of BAY1830839date_rangeTime Frame:Day -1 period 1 (Dose group 3 of BAY1830839 only)
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
Basic ScienceAllocation
RandomizedBlinding
N/AAssignment
Sequential AssignmentTrial Arms
2