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

Bayer

Status and phase

Completed

Phase 1

Conditions

Psoriasis

Healthy Volunteers

Treatments

Drug: BAY1834845

Drug: Midazolam

Other: Matching Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT03493269

18385

2017-001817-10 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment

72 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

72 participants in 4 patient groups, including a placebo group

BAY1834845

Experimental group

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)

Treatment:

Drug: Midazolam

Drug: BAY1834845

Matching Placebo

Placebo Comparator group

Description:

Part 1: Matching placebo in healthy male subjects.

Treatment:

Drug: Midazolam

Other: Matching Placebo

Chosen dose of BAY1834845

Experimental group