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

Phase 1

Completed

• Conditions: Psoriasis; Healthy Volunteers
• Interventions: Other: Matching Placebo; Drug: BAY1834845; Drug: Midazolam

• Registration Number: NCT03493269
• Lead Sponsor: Bayer

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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-04-04
• Study First Submitted QC: 2018-04-04
• Study First Posted: 2018-04-10
• Study Start: 2018-04-16
• Primary Completion: 2020-09-16
• Status Verified: 2021-02
• Study Completion: 2021-02-05
• Last Update Submitted: 2021-02-25
• Last Update Posted: 2021-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Matching Placebo	Part 2: The placebo will be adminstered in female and male patients with psoriasis
Matching Placebo	Matching Placebo	Part 1: Matching placebo in healthy male subjects.
Chosen dose of BAY1834845	BAY1834845	Part 2: This dose level will be adminstered in female and male patients with psoriasis
BAY1834845	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)
BAY1834845	Midazolam	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)
Matching Placebo	Midazolam	Part 1: Matching placebo in healthy male subjects.

Primary Outcome Measures

Name	Time	Method
Frequency of treatment-emergent adverse events (TEAEs)	Approximately 84 days	Part 2: Patients with psoriasis
Severity of treatment-emergent adverse events (TEAEs)	Approximately 84 days	Part 2: Patients with psoriasis
AUC(0-24)md of BAY1834845	Part 2: one day between day 35 and 42	Part 2: AUC(0-24)md: AUC from zero to 24 hours after multiple dosing
AUC(0-12)md of BAY1834845	Part 2: one day between day 35 and 42	Part 2: AUC(0-12)md: AUC from zero to 12 hours after multiple dosing
Cmax,md of BAY1834845	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
Cav, md of BAY1834845	Part 2: one day between day 35 and 42	Part 2: Cav: Average concentration within a dosing interval after multiple dosing
Cav,md of BAY1834845	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

Trial Locations

Locations (2)

PAREXEL GmbH; 🇩🇪 Berlin, Germany

Charité Research Organisation GmbH; 🇩🇪 Berlin, Germany