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). In this study researchers want to learn more about the safety of BAY1817080, how it is tolerated and the way the body absorbs, distributes and gets rid of the study dug given as tablet in participants with mild, moderate or severe hepatic impairment and participants with normal liver function matched for age-, gender-, weight and race. The study will enroll 36 male and female participants in the age between 18 and 79 years. Participants with mild or moderate hepatic impairment and the matching participants will take multiple oral doses of study drug depending on the study plan. Participants with severe hepatic impairment and the matching participants will take a single oral dose of study drug during the study. Data from this study will provide researcher important information for further development of the study drug in particular on dose recommendation for patients with hepatic impairment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
37
Study intervention BAY1817080 will be administered orally with tablet(s).
Midazolam will be administered intravenously with dose of 0.1 mg on Day 1.
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
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
AUC (0-12)md,u: Area Under the 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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