Clinical Trial: First in Human Study to Investigate the Safety, Tolerability, Pharmacokinetics and to Explore Pharmacodynamics of BAY1834845

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Randomized, Placebo-controlled, Double-blind Study to Investigate the Safety, Tolerability, Pharmacokinetics and to Explore Pharmacodynamics of Increasing Single Oral Doses of BAY1834845 Including Rel

Brief Summary: This study is a first in human study that will investigate the safety, tolerability and pharmacokinetics and explore the pharmacodynamics of ascending single doses of BAY1834845 using a placebo controlled, randomized, single center design.

Detailed Summary:
Sponsor: Bayer

Current Primary Outcome:

  • Frequency of treatment-emergent adverse events (TEAEs) [ Time Frame: Up to 25 days after last drug administration ]
    AEs are considered to be treatment-emergent if they have started or worsened after first application of study medication up to 30 days after end of treatment with study medication.
  • Severity of treatment-emergent adverse events [ Time Frame: Up to 25 days after last drug administration ]

    The intensity of an AE is classified according to the following categories:

    • Mild
    • Moderate
    • Severe
  • Area under the plasma concentration vs. time curve (AUC) [ Time Frame: Baseline to up to 14 days post drug administration ]
    AUC from zero to infinity after single dose if possible or from time 0 to the last data point above lower limit of quantification (AUC (0-tlast)
  • Maximum drug concentration in plasma after single dose administration (Cmax) [ Time Frame: Baseline to up to 14 days post drug administration ]
    Maximum drug concentration in plasma in mg/L after single dose administration of BAY1834845


Original Primary Outcome:

  • Frequency of treatment-emergent adverse events (TEAEs) [ Time Frame: Up to 25 days after last drug administration ]
  • Severity of treatment-emergent adverse events [ Time Frame: Up to 25 days after last drug administration ]
  • Area under the plasma concentration vs. time curve (AUC) [ Time Frame: Baseline to up to 14 days post drug administration ]
    AUC from zero to infinity after single dose if possible or from time 0 to the last data point above lower limit of quantification (AUC (0-tlast)
  • Maximum drug concentration in plasma after single dose administration (Cmax) [ Time Frame: Baseline to up to 14 days post drug administration ]


Current Secondary Outcome:

Original Secondary Outcome:

Information By: Bayer

Dates:
Date Received: February 13, 2017
Date Started: February 13, 2017
Date Completion: October 30, 2017
Last Updated: May 19, 2017
Last Verified: May 2017