Status:
COMPLETED
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
Lead Sponsor:
Bayer
Conditions:
Endometriosis Related Pain
Overactive Bladder
Eligibility:
All Genders
18-79 years
Phase:
PHASE1
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), ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 6 2021
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT04471337
Start Date
August 12 2020
End Date
May 6 2021
Last Update
March 26 2024
Active Locations (2)
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1
Clinical Pharmacology of Miami, LLC
Miami, Florida, United States, 33014
2
Orlando Clinical Research Center
Orlando, Florida, United States, 32809