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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-16

Study Completion Date

2021-02-05

Brief Summary

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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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Detailed Description

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Conditions

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Healthy Volunteers Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double blind

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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)

Group Type EXPERIMENTAL

BAY1834845

Intervention Type DRUG

Orally administered.

Midazolam

Intervention Type DRUG

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

Matching Placebo

Part 1: Matching placebo in healthy male subjects.

Group Type PLACEBO_COMPARATOR

Matching Placebo

Intervention Type OTHER

Orally administered.

Midazolam

Intervention Type DRUG

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

Chosen dose of BAY1834845

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

Group Type EXPERIMENTAL

BAY1834845

Intervention Type DRUG

Orally administered.

Placebo

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

Group Type PLACEBO_COMPARATOR

Matching Placebo

Intervention Type OTHER

Orally administered.

Interventions

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BAY1834845

Orally administered.

Intervention Type DRUG

Matching Placebo

Orally administered.

Intervention Type OTHER

Midazolam

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes