BAY1817080
DrugBAY1817080 will be administered orally as tablet.
NCT Number: NCT04471337
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.
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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: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
-- Normal renal function, as assessed at screening and based on serum creatinine according to the CKD-EPI : eGFR ≥90 mL/min/1.73 m^2.
Exclusion criteria
BAY1817080 will be administered orally as tablet.
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
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: Maximum observed drug concentration at steady state for multiple dose (unbound)
Bayer
Industry
An Open-label Study to Evaluate the Pharmacokinetics and Safety of BAY 1817080 in Participants With Impaired Renal Function in Comparison to Matched Controls With Normal Renal 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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