BAY2327949 is currently under clinical development for chronic kidney disease. The goal of this study is to learn more about how the body absorbs, distributes and excretes the study drug when taken once per mouth as 30mg tablet. An additional important goal of this study is to gain more information on how well the study drug is tolerated and its effect on the human body functions. The study will enroll healthy participants or patients with mild, moderate or severe reduced kidney functions matched for age, weight and gender. The results of this study will help researchers to select the best dosing of the study drug for future studies in patients.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
32
A single oral dose of 30 mg BAY2327949 given as one 30 mg IR tablet (dose might be reduced to 15 mg for group 4 according to safety assessment team decision)
APEX GmbH
München, Bavaria, Germany
CRS Clinical-Research-Services Kiel GmbH
Kiel, Schleswig-Holstein, Germany
Cmax of BAY2327949
Cmax: Maximum observed drug concentration in measured matrix after single dose administration
Time frame: From pre-dose until follow-up (10-12 days after dosing).
AUC of BAY2327949
AUC:Area under the concentration vs. time curve from zero to infinity after single (first) dose. AUC(0-tlast) will be used as primary variables if mean AUC(tlast-∞) \>20% of AUC
Time frame: From pre-dose until follow-up (10-12 days after dosing).
Cmax,u of BAY2327949
Cmax,u: Cmax based on the unbound plasma concentrations of the study drug
Time frame: From pre-dose until follow-up (10-12 days after dosing).
AUCu of BAY2327949
AUC(0-tlast)u will be used as primary variables if mean AUC(tlast-∞) \>20% of AUC
Time frame: From pre-dose until follow-up (10-12 days after dosing).
Frequency and nature of treatment-emergent adverse events
Time frame: Approximate 14 days (from starting treatment to end of follow-up)
Urinary volume
Time frame: From Day -1 until Day 4 (72h after dosing)
Fluid balance
Time frame: From Day -1 until Day 4 (72h after dosing)
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