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Completed

NCT Number: NCT03493269

A Multiple Dose Study of BAY1834845 in Healthy Male Subjects and in Patients With Psoriasis

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).

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Key information

Conditions

Healthy Volunteers Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Charité Research Organisation GmbH, Berlin, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

  • 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

Treatment and study plan

BAY1834845

Drug

Orally administered.

Matching Placebo

Other

Orally administered.

midazolam

Drug

Part 1: Orally administered 1mg as a single dose.

Primary outcomes

  1. Frequency of treatment-emergent adverse events (TEAEs)

    Time frame: Approximately 47 days

    Part 1 in healthy male subject

  2. Severity of treatment-emergent adverse events (TEAEs)

    Time frame: Approximately 47 days

    Part 1 in healthy male subject

  3. Frequency of treatment-emergent adverse events (TEAEs)

    Time frame: Approximately 84 days

    Part 2: Patients with psoriasis

  4. Severity of treatment-emergent adverse events (TEAEs)

    Time frame: Approximately 84 days

    Part 2: Patients with psoriasis

  5. AUC(0-24)md of BAY1834845

    Time frame: Part 1 - Period 1 (dose group 1-4): Day 1 to 2 Part 1 - Period 2 (dose group 5): Day 1 to 2

    Part 1 AUC(0-24)md: AUC from zero to 24 hours after multiple dosing

  6. AUC(0-12)md of BAY1834845

    Time frame: Part 1 - Period 1 (dose group 1-4): Day 1, Part 1 - Period 2 (dose group 5): Day 1

    Part 1 AUC(0-12)md:AUC from zero to 12 hours after multiple dosing

  7. Cmax,md of BAY1834845

    Time frame: Part 1 - Period 1 (dose group 1-4): Day 1, Part 1 - Period 2 (dose group 5): Day 1

    Part 1 Cmax,md:Cmax(Maximum observed drug concentration, directly taken from analytical data) after multiple dosing

  8. Cav,md of BAY1834845

    Time frame: Part 1 - Period 1 (dose group 1-4): Day 1 to 2 Part 1 - Period 2 (dose group 5): Day 1 to 2

    Part 1 Cav:Average concentration within a dosing interval after multiple dosing

  9. AUC(0-24)md of BAY1834845

    Time frame: Part 2: one day between day 35 and 42

    Part 2: AUC(0-24)md: AUC from zero to 24 hours after multiple dosing

  10. AUC(0-12)md of BAY1834845

    Time frame: Part 2: one day between day 35 and 42

    Part 2: AUC(0-12)md: AUC from zero to 12 hours after multiple dosing

  11. Cmax,md of BAY1834845

    Time frame: Part 2: one day between day 35 and 42

    Part 2: Cmax,md:Cmax (Maximum observed drug concentration, directly taken from analytical data) after multiple dosing

  12. Cav, md of BAY1834845

    Time frame: Part 2: one day between day 35 and 42

    Part 2: Cav: Average concentration within a dosing interval after multiple dosing

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Apr 10, 2018
Registry last updated
Feb 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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