check_circleStudy Completed

Healthy volunteers, Psoriasis

Bayer Identifier:

18385

ClinicalTrials.gov Identifier:

NCT03493269

EudraCT Number:

2017-001817-10

EU CT Number:

Not Available
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
  • Part 1 (healthy male subjects)
    - Healthy male subjects, 18 to 50 years of age (inclusive), and in good health as determined by medical history, physical examination, vital signs, electrocardiogram (ECG), and laboratory tests at screening
    - Body mass index (BMI) above or equal to 18.5 and lower or equal to 30 kg/m2 (BMI = body weight (kg) / [height (m)]2 and a body weight above or equal 50 kg
    Part 2 (patients with psoriasis)
    - Male patients, 18 to 70 years of age (inclusive) or female patients of non-child bearing potential, 30 to 70 years of age (inclusive)
    - Body mass index above or equal to 18.5 and lower or equal to 35 kg/m*2 and a body weight above 50 kg
    - A documented diagnosis of psoriasis, with a history of at least 6 months prior to study drug administration. Moderate to severe plaque psoriasis at screening, defined by: a) an involved body surface area (BSA) above or equal to 10% of BSA, b) a Psoriasis Area and Severity Index (PASI) score of above or equal, 12 c) a Physician’s Global Assessment (PGA) score of above or equal 2.
  • - History of hypersensitivity to any of the components of the study drug
    - Any clinically relevant abnormal findings in safety laboratory parameters and ECG
    - History of tuberculosis (TB) or active or latent tuberculosis
    - Receipt of live or attenuated vaccine 90 days prior to the first dosing

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