Trial Condition(s):

Healthy Volunteers, Psoriasis

A multiple dose study of BAY1834845 in healthy male subjects and in patients with psoriasis

Bayer Identifier:

18385

ClinicalTrials.gov Identifier:

NCT03493269

EudraCT Number:

2017-001817-10

Study Completed

Trial Purpose

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).

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

Trial Summary

Enrollment Goal
72
Trial Dates
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Phase
1
Could I receive a placebo?
Yes
Products
BAY1834845
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Charité Research Organisation GmbH

Berlin, Germany, 10117

Status
Completed
 
Locations

PAREXEL GmbH

Berlin, Germany, 14050

Status
Completed
 

Trial Design