CompletedPhase 1

Study on the Safety of BAY1817080 How it is Tolerated and the Way the Body Absorbs, Distributes and Gets Rid of the Study Drug Given to Participants With Moderate Renal Impairment and End Stage Renal Disease Requiring Dialysis Compared With Matched Participants With Normal Renal Function

United States32 participantsStarted 2020-08-12

Plain-language summary

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.

Who can participate

Age range18 Years – 79 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Participant must be 18 to 79 years of age inclusive, at the time of signing the informed consent. * For renally impaired participants: * Decreased renal function, as assessed based on serum creatinine collected 2 to 10 days prior to dosing and calculated according to the Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI) either: Moderately impaired renal function: eGFR: 30 to 59 mL/min/1.73 m\^2; or ESRD on dialysis. * Stable renal disease, i.e. a serum creatinine value determined 3 or more months before screening (e.g. during routine diagnostics) should not differ by more than 25% from the serum creatinine value determined at screening. * For participants with normal renal function: \-- 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. * Body mass index (BMI) within the range 18 to 38 kg/m\^2 (both inclusive) * Women of childbearing potential (WOCBP) must agree to use contraception for the duration of the study. This applies for the time period between signing of the Informed Consent Form until at least 30 days after the last dose of the study drug. * Capable of giving signed informed consent as described in study protocol which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Exclusion Criteria: * Any relevant disease (other than those related to renal impairment for the …

What they're measuring

AUCu after single dose of BAY1817080

Timeframe: On Day 1

Cmax,u after single dose of BAY1817080

Timeframe: On Day 1

Trial details

NCT IDNCT04471337

SponsorBayer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-02-15