BAY1817080 is currently under clinical development to treat pain related to unexplained chronic cough or chronic cough not affected by a treatment (refractory and/or unexplained chronic cough, RUCC), or a condition where the bladder is unable to hold urine normally (overactive bladder, OAB) or a condition in which tissue similar to the tissue that normally lines the inside of the womb grows outside the womb (endometriosis). Especially in elderly patients with OAB or RUCC, renal impairment is frequent. Renal impairment which co-occurs in especially in elderly patients with OAB or RUCC is a common condition in which the kidneys are not filtering the blood as well as they should. End stage renal disease (ESRD) requiring hemodialysis is a condition in which patients kidneys are no longer able to work as they should and require treatment to filter wastes from the blood. The goal of the study is to learn more about the safety of BAY1817080, how it is tolerated and the way the body absorbs, distributes and excretes the study drug given in men and women with moderate renal impairment and with those who have end stage renal disease (ESRD) requiring dialysis compared with matched participants with normal kidney function.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
32
BAY1817080 will be administered orally as tablet.
Clinical Pharmacology of Miami, LLC
Miami, Florida, United States
Orlando Clinical Research Center
Orlando, Florida, United States
AUCu after single dose of BAY1817080
AUCu: Area under the Curve unbound
Time frame: On Day 1
Cmax,u after single dose of BAY1817080
Cmax,u: maximum observed drug concentration in measured matrix after single dose administration (unbound)
Time frame: On Day 1
Number of subjects with treatment emergent adverse events (TEAEs)
Time frame: From dosing up to 14 days after end of treatment with study medication
AUC (0-12)md,u after multiple dose of BAY1817080
Area under the time curve from 0-12 hours at steady state for the multiple dose (unbound)
Time frame: From Day 6 to Day 13
Cmax,md,u after multiple dose of BAY1817080
Cmax,md,u: Maximum observed drug concentration at steady state for multiple dose (unbound)
Time frame: From Day 6 to Day 13
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