check_circleStudy Completed

Healthy volunteers, Psoriasis

A multiple dose study of BAY1834845 in healthy male subjects and in patients with psoriasis

Trial purpose

To assess safety and tolerability of multiple oral doses of BAY1834845 in healthy male subjects (Part 1) and in patients with psoriasis (Part 2).
To assess the pharmacokinetic (PK) properties of total BAY1834845 in plasma after oral multiple doses of BAY1834845 in healthy male subjects (Part 1) and patients with psoriasis (Part 2).

Key Participants Requirements

Sex

All

Age

18 - 70 Years

Trial summary

Enrollment Goal
72
Trial Dates
April 2018 - February 2021
Phase
Phase 1
Could I Receive a placebo
Yes
Products
BAY1834845
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Charité Research Organisation GmbHBerlin, 10117, Germany
Completed
PAREXEL GmbHBerlin, 14050, Germany

Primary Outcome

  • Frequency of treatment-emergent adverse events (TEAEs)
    Part 1 in healthy male subject
    date_rangeTime Frame:
    Approximately 47 days
  • Severity of treatment-emergent adverse events (TEAEs)
    Part 1 in healthy male subject
    date_rangeTime Frame:
    Approximately 47 days
  • Frequency of treatment-emergent adverse events (TEAEs)
    Part 2: Patients with psoriasis
    date_rangeTime Frame:
    Approximately 84 days
  • Severity of treatment-emergent adverse events (TEAEs)
    Part 2: Patients with psoriasis
    date_rangeTime Frame:
    Approximately 84 days
  • AUC(0-24)md of BAY1834845
    Part 1 AUC(0-24)md: AUC from zero to 24 hours after multiple dosing
    date_rangeTime Frame:
    Part 1 - Period 1 (dose group 1-4): Day 1 to 2 Part 1 - Period 2 (dose group 5): Day 1 to 2
  • AUC(0-12)md of BAY1834845
    Part 1 AUC(0-12)md:AUC from zero to 12 hours after multiple dosing
    date_rangeTime Frame:
    Part 1 - Period 1 (dose group 1-4): Day 1, Part 1 - Period 2 (dose group 5): Day 1
  • Cmax,md of BAY1834845
    Part 1 Cmax,md:Cmax(Maximum observed drug concentration, directly taken from analytical data) after multiple dosing
    date_rangeTime Frame:
    Part 1 - Period 1 (dose group 1-4): Day 1, Part 1 - Period 2 (dose group 5): Day 1
  • Cav,md of BAY1834845
    Part 1 Cav:Average concentration within a dosing interval after multiple dosing
    date_rangeTime Frame:
    Part 1 - Period 1 (dose group 1-4): Day 1 to 2 Part 1 - Period 2 (dose group 5): Day 1 to 2
  • AUC(0-24)md of BAY1834845
    Part 2: AUC(0-24)md: AUC from zero to 24 hours after multiple dosing
    date_rangeTime Frame:
    Part 2: one day between day 35 and 42
  • AUC(0-12)md of BAY1834845
    Part 2: AUC(0-12)md: AUC from zero to 12 hours after multiple dosing
    date_rangeTime Frame:
    Part 2: one day between day 35 and 42
  • Cmax,md of BAY1834845
    Part 2: Cmax,md:Cmax (Maximum observed drug concentration, directly taken from analytical data) after multiple dosing
    date_rangeTime Frame:
    Part 2: one day between day 35 and 42
  • Cav, md of BAY1834845
    Part 2: Cav: Average concentration within a dosing interval after multiple dosing
    date_rangeTime Frame:
    Part 2: one day between day 35 and 42

Trial design

A randomized, double-blind, placebo-controlled study to assess safety, tolerability, pharmacokinetics and exploratory pharmacodynamics of multiple oral doses of BAY1834845 in healthy male subjects and in female and male patients with psoriasis over an extended treatment duration
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
N/A
Assignment
Parallel Assignment
Trial Arms
4