Clinical trial NCT03493269: A Multiple Dose Study of BAY1834845 in Healthy Male Subjects and in Patients With Psoriasis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Psoriasis
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2018-04-10
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blind
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Frequency of treatment-emergent adverse events (TEAEs)
timeFrame: Approximately 47 days
measure: Severity of treatment-emergent adverse events (TEAEs)
timeFrame: Approximately 47 days
measure: Frequency of treatment-emergent adverse events (TEAEs)
timeFrame: Approximately 84 days
measure: Severity of treatment-emergent adverse events (TEAEs)
timeFrame: Approximately 84 days
measure: AUC(0-24)md of BAY1834845
timeFrame: Part 1 - Period 1 (dose group 1-4): Day 1 to 2 Part 1 - Period 2 (dose group 5): Day 1 to 2
measure: AUC(0-12)md of BAY1834845
timeFrame: Part 1 - Period 1 (dose group 1-4): Day 1, Part 1 - Period 2 (dose group 5): Day 1
measure: Cmax,md of BAY1834845
timeFrame: Part 1 - Period 1 (dose group 1-4): Day 1, Part 1 - Period 2 (dose group 5): Day 1
measure: Cav,md of BAY1834845
timeFrame: Part 1 - Period 1 (dose group 1-4): Day 1 to 2 Part 1 - Period 2 (dose group 5): Day 1 to 2
measure: AUC(0-24)md of BAY1834845
timeFrame: Part 2: one day between day 35 and 42
measure: AUC(0-12)md of BAY1834845
timeFrame: Part 2: one day between day 35 and 42
measure: Cmax,md of BAY1834845
timeFrame: Part 2: one day between day 35 and 42
measure: Cav, md of BAY1834845
timeFrame: Part 2: one day between day 35 and 42
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Research Organisation GmbH
city: Berlin
country: Germany
facility: PAREXEL GmbH
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: