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

Study Overview
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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).

Official Title
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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

Conditions
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Healthy Volunteers, Psoriasis

Intervention / Treatment
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* Drug: BAY1834845
* Other: Matching Placebo
* Drug: Midazolam


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double blind
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BAY1834845<br>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<br>* Orally administered.<br>Drug: Midazolam<br>* Part 1: Orally administered 1mg as a single dose.<br>|
| Placebo Comparator: Matching Placebo<br>Part 1: Matching placebo in healthy male subjects. | Other: Matching Placebo<br>* Orally administered.<br>Drug: Midazolam<br>* Part 1: Orally administered 1mg as a single dose.<br>|
| Experimental: Chosen dose of BAY1834845<br>Part 2: This dose level will be adminstered in female and male patients with psoriasis | Drug: BAY1834845<br>* Orally administered.<br>|
| Placebo Comparator: Placebo<br>Part 2: The placebo will be adminstered in female and male patients with psoriasis | Other: Matching Placebo<br>* Orally administered.<br>|

What is the study measuring?
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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 |