Healthy Volunteers, Psoriasis
Conditions
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).
Interventions
DRUGBAY1834845
Orally administered.
OTHERMatching Placebo
Orally administered.
DRUGMidazolam
Part 1: Orally administered 1mg as a single dose.
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Double blind
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of treatment-emergent adverse events (TEAEs) | Approximately 47 days | Part 1 in healthy male subject |
| Severity of treatment-emergent adverse events (TEAEs) | Approximately 47 days | Part 1 in healthy male subject |
| AUC(0-24)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 AUC(0-24)md: AUC from zero to 24 hours after multiple dosing |
| AUC(0-12)md of BAY1834845 | Part 1 - Period 1 (dose group 1-4): Day 1, Part 1 - Period 2 (dose group 5): Day 1 | Part 1 AUC(0-12)md:AUC from zero to 12 hours after multiple dosing |
| Cmax,md of BAY1834845 | Part 1 - Period 1 (dose group 1-4): Day 1, Part 1 - Period 2 (dose group 5): Day 1 | Part 1 Cmax,md:Cmax(Maximum observed drug concentration, directly taken from analytical data) 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 |
| 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 |
Countries
Germany
Outcome results
None listed