BAY1817080
DrugStudy intervention BAY1817080 will be administered orally with tablet(s).
NCT Number: NCT04454424
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.
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Notify Me18 year–79 year
All sexes
Interventional
Phase 1
Clinical Pharmacology of Miami, LLC, Miami, Florida, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Study intervention BAY1817080 will be administered orally with tablet(s).
Midazolam will be administered intravenously with dose of 0.1 mg on Day 1.
Time frame: On day 1
AUCu: Area under the Curve unbound
Time frame: On day 1
Cmax,u: maximum observed drug concentration in measured matrix after single dose administration (unbound)
Time frame: from dosing up to 14 days after end of treatment with study medication
Time frame: From day 6 to day 13
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: Maximum observed drug concentration at steady state for multiple dose (unbound)
Bayer
Industry
An Open-label Study to Evaluate the Pharmacokinetics, Safety and Tolerability of BAY 1817080 in Participants With Impaired Hepatic Function (Classified as Child-Pugh A, B or C) in Comparison to Matched Controls With Normal Hepatic Function
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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