Clinical trial NCT04471337: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Endometriosis Related Pain
Overactive Bladder
Diabetic Neuropathic Pain
Refractory or Unexplained Chronic Cough
Keywords: Normal renal function
Moderate renal impairment
End stage renal disease (ESRD)
Dialysis
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2020-07-15
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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 renal impaired participants) within 4 weeks prior to study drug administration including infections and acute gastro-intestinal diseases (vomiting, diarrhea, constipation) requiring medical treatment.
* Acute renal failure or acute nephritis within the past 2 years
* Use of strong CYP3A4 and P-glycoprotein inhibitors from 2 weeks before study treatment until last day of blood sampling for pharmacokinetics after study drug administration.
* Use of CYP3A4 and P-glycoprotein inducers from 2 weeks before study treatment until last day of blood sampling for pharmacokinetics after study drug administration.
* Use of drugs which may affect absorption (e.g. loperamide, metoclopramide), and systemic administration of any broad-spectrum antibiotic within 1 week before first study drug administration, unless the drug is part of the mandatory dosing regimen for treatment of renal impairment or related conditions.
* International Normalized Ratio (INR) \> 2.3.
* Indication or evidence for long QT syndrome; Participants in control group only: QT interval corrected using Fridericia's method (QTcF) \> 450 msec.
* Inability to provide informed consent: Participants with psychiatric disorders.

Primary outcomes:
measure: AUCu after single dose of BAY1817080
timeFrame: On Day 1
measure: Cmax,u after single dose of BAY1817080
timeFrame: On Day 1
Secondary outcomes:
measure: Number of subjects with treatment emergent adverse events (TEAEs)
timeFrame: From dosing up to 14 days after end of treatment with study medication
measure: AUC (0-12)md,u after multiple dose of BAY1817080
timeFrame: From Day 6 to Day 13
measure: Cmax,md,u after multiple dose of BAY1817080
timeFrame: From Day 6 to Day 13
Other outcomes:
Locations:
city: Miami
country: United States
facility: Clinical Pharmacology of Miami, LLC
state: Florida
city: Orlando
country: United States
facility: Orlando Clinical Research Center
state: Florida
Study officials:
References: