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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
72
Orally administered.
Orally administered.
Part 1: Orally administered 1mg as a single dose.
Charité Research Organisation GmbH
Berlin, Germany
PAREXEL GmbH
Berlin, Germany
Frequency of treatment-emergent adverse events (TEAEs)
Part 1 in healthy male subject
Time frame: Approximately 47 days
Severity of treatment-emergent adverse events (TEAEs)
Part 1 in healthy male subject
Time frame: Approximately 47 days
Frequency of treatment-emergent adverse events (TEAEs)
Part 2: Patients with psoriasis
Time frame: Approximately 84 days
Severity of treatment-emergent adverse events (TEAEs)
Part 2: Patients with psoriasis
Time frame: Approximately 84 days
AUC(0-24)md of BAY1834845
Part 1 AUC(0-24)md: AUC from zero to 24 hours after multiple dosing
Time frame: 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 BAY1834845
Part 1 AUC(0-12)md:AUC from zero to 12 hours after multiple dosing
Time frame: Part 1 - Period 1 (dose group 1-4): Day 1, Part 1 - Period 2 (dose group 5): Day 1
Cmax,md of BAY1834845
Part 1 Cmax,md:Cmax(Maximum observed drug concentration, directly taken from analytical data) after multiple dosing
Time frame: Part 1 - Period 1 (dose group 1-4): Day 1, Part 1 - Period 2 (dose group 5): Day 1
Cav,md of BAY1834845
Part 1 Cav:Average concentration within a dosing interval after multiple dosing
Time frame: Part 1 - Period 1 (dose group 1-4): Day 1 to 2 Part 1 - Period 2 (dose group 5): Day 1 to 2
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AUC(0-24)md of BAY1834845
Part 2: AUC(0-24)md: AUC from zero to 24 hours after multiple dosing
Time frame: Part 2: one day between day 35 and 42
AUC(0-12)md of BAY1834845
Part 2: AUC(0-12)md: AUC from zero to 12 hours after multiple dosing
Time frame: Part 2: one day between day 35 and 42
Cmax,md of BAY1834845
Part 2: Cmax,md:Cmax (Maximum observed drug concentration, directly taken from analytical data) after multiple dosing
Time frame: Part 2: one day between day 35 and 42
Cav, md of BAY1834845
Part 2: Cav: Average concentration within a dosing interval after multiple dosing
Time frame: Part 2: one day between day 35 and 42