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:
EudraCT Number:
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Charité Research Organisation GmbH Berlin, Germany, 10117 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations PAREXEL GmbH Berlin, Germany, 14050 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
N/A
Assignment:
Parallel Assignment
Trial Arms:
4
Primary Outcome
- Frequency of treatment-emergent adverse events (TEAEs)Part 1 in healthy male subjectTimeframe: Approximately 47 days
- Severity of treatment-emergent adverse events (TEAEs)Part 1 in healthy male subjectTimeframe: Approximately 47 days
- Frequency of treatment-emergent adverse events (TEAEs)Part 2: Patients with psoriasisTimeframe: Approximately 84 days
- Severity of treatment-emergent adverse events (TEAEs)Part 2: Patients with psoriasisTimeframe: Approximately 84 days
- AUC(0-24)md of BAY1834845Part 1 AUC(0-24)md: AUC from zero to 24 hours after multiple dosingTimeframe: Part 1 - Period 1 (dose group 1-4): Day 1 to 2 Part 1 - Period 2 (dose group 5): Day 1 to 2
- AUC(0-12)md of BAY1834845Part 1 AUC(0-12)md:AUC from zero to 12 hours after multiple dosingTimeframe: Part 1 - Period 1 (dose group 1-4): Day 1, Part 1 - Period 2 (dose group 5): Day 1
- Cmax,md of BAY1834845Part 1 Cmax,md:Cmax(Maximum observed drug concentration, directly taken from analytical data) after multiple dosingTimeframe: Part 1 - Period 1 (dose group 1-4): Day 1, Part 1 - Period 2 (dose group 5): Day 1
- Cav,md of BAY1834845Part 1 Cav:Average concentration within a dosing interval after multiple dosingTimeframe: Part 1 - Period 1 (dose group 1-4): Day 1 to 2 Part 1 - Period 2 (dose group 5): Day 1 to 2
- AUC(0-24)md of BAY1834845Part 2: AUC(0-24)md: AUC from zero to 24 hours after multiple dosingTimeframe: Part 2: one day between day 35 and 42
- AUC(0-12)md of BAY1834845Part 2: AUC(0-12)md: AUC from zero to 12 hours after multiple dosingTimeframe: Part 2: one day between day 35 and 42
- Cmax,md of BAY1834845Part 2: Cmax,md:Cmax (Maximum observed drug concentration, directly taken from analytical data) after multiple dosingTimeframe: Part 2: one day between day 35 and 42
- Cav, md of BAY1834845Part 2: Cav: Average concentration within a dosing interval after multiple dosingTimeframe: Part 2: one day between day 35 and 42
Additional Information
Not Available
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