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

Primary Purpose

Healthy Volunteers, Psoriasis

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

BAY1834845

Matching Placebo

Midazolam

About this trial

This is an interventional treatment trial for Healthy Volunteers

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Charité Research Organisation GmbH
PAREXEL GmbH

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

BAY1834845

Matching Placebo

Chosen dose of BAY1834845

Placebo

Arm Description

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)

Part 1: Matching placebo in healthy male subjects.

Part 2: This dose level will be adminstered in female and male patients with psoriasis

Part 2: The placebo will be adminstered in female and male patients with psoriasis

Outcomes

Primary Outcome Measures

Frequency of treatment-emergent adverse events (TEAEs)

Part 1 in healthy male subject

Severity of treatment-emergent adverse events (TEAEs)

Part 1 in healthy male subject

Frequency of treatment-emergent adverse events (TEAEs)

Part 2: Patients with psoriasis

Severity of treatment-emergent adverse events (TEAEs)

Part 2: Patients with psoriasis

AUC(0-24)md of BAY1834845

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

AUC(0-12)md of BAY1834845

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

Cmax,md of BAY1834845

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

Cav,md of BAY1834845

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

AUC(0-24)md of BAY1834845

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

AUC(0-12)md of BAY1834845

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

Cmax,md of BAY1834845

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

Cav, md of BAY1834845

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03493269

First Posted

April 4, 2018

Last Updated

February 25, 2021

Sponsor

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT03493269

Brief Title

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

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Completed

Study Start Date

April 16, 2018 (Actual)

Primary Completion Date

September 16, 2020 (Actual)

Study Completion Date

February 5, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bayer

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy Volunteers, Psoriasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Model Description

Double blind

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

72 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BAY1834845

Arm Type

Experimental

Arm Description

Arm Title

Matching Placebo

Arm Type

Placebo Comparator

Arm Description

Part 1: Matching placebo in healthy male subjects.

Arm Title

Chosen dose of BAY1834845

Arm Type

Experimental

Arm Description

Part 2: This dose level will be adminstered in female and male patients with psoriasis

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Part 2: The placebo will be adminstered in female and male patients with psoriasis

Intervention Type

Drug

Intervention Name(s)

BAY1834845

Intervention Description

Orally administered.

Intervention Type

Other

Intervention Name(s)

Matching Placebo

Intervention Description

Orally administered.

Intervention Type

Drug

Intervention Name(s)

Midazolam

Intervention Description

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

Primary Outcome Measure Information:

Title

Frequency of treatment-emergent adverse events (TEAEs)

Description

Part 1 in healthy male subject

Time Frame

Approximately 47 days

Title

Severity of treatment-emergent adverse events (TEAEs)

Description

Part 1 in healthy male subject

Time Frame

Approximately 47 days

Title

Frequency of treatment-emergent adverse events (TEAEs)

Description

Part 2: Patients with psoriasis

Time Frame

Approximately 84 days

Title

Severity of treatment-emergent adverse events (TEAEs)

Description

Part 2: Patients with psoriasis

Time Frame

Approximately 84 days

Title

AUC(0-24)md of BAY1834845

Description

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

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

Title

AUC(0-12)md of BAY1834845

Description

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

Time Frame

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

Title

Cmax,md of BAY1834845

Description

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

Time Frame

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

Title

Cav,md of BAY1834845

Description

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

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

Title

AUC(0-24)md of BAY1834845

Description

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

Time Frame

Part 2: one day between day 35 and 42

Title

AUC(0-12)md of BAY1834845

Description

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

Time Frame

Part 2: one day between day 35 and 42

Title

Cmax,md of BAY1834845

Description

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

Time Frame

Part 2: one day between day 35 and 42

Title

Cav, md of BAY1834845

Description

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

Time Frame

Part 2: one day between day 35 and 42

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bayer Study Director

Organizational Affiliation

Bayer

Official's Role

Study Director

Facility Information:

Facility Name

Charité Research Organisation GmbH

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

PAREXEL GmbH

City

Berlin

ZIP/Postal Code

14050

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

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

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