check_circleStudy Completed

Cough, Endometriosis, Overactive bladder

Study to gather information on the influence of BAY1817080 on the electrical activity of the heart recorded by an electrocardiogram in healthy male and female participants

Trial purpose

In this study, researchers want to find whether the study drug BAY1817080 has an effect on the electrocardiogram (ECG). 40 healthy male or female participants with the age of 18 to 65 years will be enrolled into this study. The ECG of the participants will be monitored closely by the researchers to detect any change after intake of the study medication.

Key Participants Requirements

Sex

All

Age

18 - 65 Years

Trial summary

Enrollment Goal
42
Trial Dates
June 2020 - January 2021
Phase
Phase 1
Could I Receive a placebo
Yes
Products
Eliapixant (BAY1817080)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
CRS Clinical Research Services Mannheim GmbHMannheim, 68167, Germany

Primary Outcome

  • Time-matched, placebo-corrected change from baseline of the individually corrected QT interval after multiple oral doses of BAY1817080 therapeutic dose
    date_rangeTime Frame:
    Baseline and Day 3
  • Time-matched, placebo-corrected change from baseline of the individually corrected QT interval after multiple oral doses of BAY1817080 supra-therapeutic dose
    date_rangeTime Frame:
    Baseline and Day 3

Secondary Outcome

  • Time-matched, placebo-corrected change from baseline of the individually corrected QT interval after a single oral dose of moxifloxacin
    date_rangeTime Frame:
    Baseline and Day 3
  • Time-matched, placebo-corrected change from baseline of the QT interval corrected according to Fridericia (QTcF) and Bazett (QTcB) after multiple oral doses of BAY1817080 therapeutic or supra-therapeutic dose
    date_rangeTime Frame:
    Baseline and Day 3
  • Time-matched, placebo-corrected change from baseline of the QT interval corrected according to Fridericia (QTcF) and Bazett (QTcB) after a single oral dose of moxifloxacin
    date_rangeTime Frame:
    Baseline and Day 3
  • AUC(0-24)md after multiple oral doses of BAY1817080 therapeutic or supra-therapeutic dose
    Area under the concentration vs. time curve from zero to 24 hours after multiple doses
    date_rangeTime Frame:
    Predose and up to 24 hours after last dose of BAY1817080 at Day 3
  • AUC after a single oral dose of moxifloxacin
    Area under the concentration vs. time curve from zero to infinity after single dose
    date_rangeTime Frame:
    Predose and up to 24 hours after single dose of moxifloxacin at Day 3
  • Cmax,md after multiple oral doses of BAY1817080 therapeutic or supra-therapeutic dose
    Maximum observed drug concentration in measured matrix after multiple doses
    date_rangeTime Frame:
    Up to 24 hours after last dose of BAY1817080 at Day 3
  • Cmax after a single oral dose of moxifloxacin
    Maximum observed drug concentration in measured matrix after single dose
    date_rangeTime Frame:
    Up to 24 hours after single dose of moxifloxacin at Day 3
  • Incidences of treatment-emergent adverse events (TEAEs) after BAY1817080 therapeutic or supra-therapeutic dose
    date_rangeTime Frame:
    From the start of BAY1817080 administration until 7 days after last dose, assessed up to 10 days

Trial design

Randomized, single-blind, double-dummy, 4-fold cross-over, placebo- and active-controlled study to investigate the influence of BAY 1817080 on the QTc interval in healthy male and female participants (TQT study)
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
Randomized
Blinding
N/A
Assignment
Crossover Assignment
Trial Arms
4