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

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

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).

Study Overview

• Status: Completed
• Conditions: Psoriasis; Healthy Volunteers
• Intervention / Treatment: Drug: BAY1834845; Drug: Midazolam; Other: Matching Placebo

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Charité Research Organisation GmbH
  • Berlin, Germany, 14050
    • PAREXEL GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: BAY1834845; Part 1 in healthy male subjects: Dose Groups 1-4 : orally administered multiple ascending doses. The treatment will last 10 consecutive days (treatment period1) and 1 day (treatment period 2) Dose Group 5: The treatment will last 1 day (treatment period 1) and 10 consecutive days (treatment period 2)	Drug: BAY1834845; Orally administered.; Drug: Midazolam; Part 1: Orally administered 1mg as a single dose.
PLACEBO_COMPARATOR: Matching Placebo; Part 1: Matching placebo in healthy male subjects.	Drug: Midazolam; Part 1: Orally administered 1mg as a single dose.; Other: Matching Placebo; Orally administered.
EXPERIMENTAL: Chosen dose of BAY1834845; Part 2: This dose level will be adminstered in female and male patients with psoriasis	Drug: BAY1834845; Orally administered.
PLACEBO_COMPARATOR: Placebo; Part 2: The placebo will be adminstered in female and male patients with psoriasis	Other: Matching Placebo; Orally administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of treatment-emergent adverse events (TEAEs)	Part 1 in healthy male subject	Approximately 47 days
Severity of treatment-emergent adverse events (TEAEs)	Part 1 in healthy male subject	Approximately 47 days
Frequency of treatment-emergent adverse events (TEAEs)	Part 2: Patients with psoriasis	Approximately 84 days
Severity of treatment-emergent adverse events (TEAEs)	Part 2: Patients with psoriasis	Approximately 84 days
AUC(0-24)md of BAY1834845	Part 1 AUC(0-24)md: AUC from zero to 24 hours after multiple dosing	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	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	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	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	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	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	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	Part 2: one day between day 35 and 42

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 16, 2018
• Primary Completion (ACTUAL): September 16, 2020
• Study Completion (ACTUAL): February 5, 2021

Study Registration Dates

• First Submitted: April 4, 2018
• First Submitted That Met QC Criteria: April 4, 2018
• First Posted (ACTUAL): April 10, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 26, 2021
• Last Update Submitted That Met QC Criteria: February 25, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam
• Other Study ID Numbers: 18385; 2017-001817-10 (EUDRACT_NUMBER)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No