check_circleStudy Completed

Healthy volunteers

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

Male

Age

18 - 50 Years

Trial summary

Enrollment Goal
67
Trial Dates
June 2019 - May 2022
Phase
Phase 1
Could I Receive a placebo
Yes
Products
BAY1830839
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Charité Research Organisation GmbHBerlin, 10117, Germany

Primary Outcome

  • Frequency of TEAEs
    TEAE: treatment-emergent adverse event
    date_rangeTime Frame:
    7 days (period 1)
  • Frequency of TEAEs
    date_rangeTime Frame:
    18 days (period 2)
  • Severity of TEAEs
    date_rangeTime Frame:
    7 days (period 1)
  • Severity of TEAEs
    date_rangeTime Frame:
    18 days (period 2)
  • AUC(0-24)md of BAY1830839 (QD and TID dosing)
    QD:once daily administration TID: three times daily administration
    date_rangeTime Frame:
    Day 1 period 1
  • AUC(0-12)md of BAY1830839 (BID dosing only)
    BID:twice daily administration
    date_rangeTime Frame:
    Day 1 period 2
  • Cmax,md of BAY1830839 after multiple dosing
    date_rangeTime Frame:
    18 days (period 2)
  • Cav of BAY1830839 after multiple dosing
    date_rangeTime 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.
    date_rangeTime Frame:
    Day -1 period 1
  • Cmax of midazolam in plasma in presence/absence of BAY1830839
    date_rangeTime 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.
    date_rangeTime Frame:
    Day -1 period 1 (Dose group 3 of BAY1830839 only)
  • Cmax of methotrexate in plasma in presence/absence of BAY1830839
    date_rangeTime Frame:
    Day -1 period 1 (Dose group 3 of BAY1830839 only)

Trial design

Multiple dose escalation study in a randomized, double-blind, placebo-controlled design to investigate safety, tolerability, pharmacokinetics, drug-drug interaction and exploratory pharmacodynamics of multiple oral doses of BAY1830839 in healthy male participants
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Basic Science
Allocation
Randomized
Blinding
N/A
Assignment
Sequential Assignment
Trial Arms
2