Study Completed

Endometriosis related pain, Overactive bladder, Diabetic neuropathic pain, Refractory or unexplained chronic cough,

Bayer Identifier:

20332

ClinicalTrials.gov Identifier:

NCT04471337

EudraCT Number:

Not Available

EU CT Number:

Not Available

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

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

18 - 79 Years

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.

Trial summary

Enrollment Goal

Trial Dates

August 2020 - May 2021

Phase

Phase 1

Could I Receive a placebo

Products

Eliapixant (BAY1817080)

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
Completed	Orlando Clinical Research Center	Orlando, 32809, United States
Completed	Clinical Pharmacology of Miami, LLC	Miami, 33014, United States

Primary Outcome

AUCu after single dose of BAY1817080
AUCu: Area under the Curve unbound
Time Frame:
On Day 1
Cmax,u after single dose of BAY1817080
Cmax,u: maximum observed drug concentration in measured matrix after single dose administration (unbound)
Time Frame:
On Day 1

Secondary Outcome

Number of subjects with treatment emergent adverse events (TEAEs)
Time Frame:
From dosing up to 14 days after end of treatment with study medication
AUC (0-12)md,u after multiple dose of BAY1817080
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 after multiple dose of BAY1817080
Cmax,md,u: Maximum observed drug concentration at steady state for multiple dose (unbound)
Time Frame:
From Day 6 to Day 13

Trial design

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

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Basic Science

Allocation

Non-randomized

Blinding

N/A

Assignment

Parallel Assignment

Trial Arms

Additional Information

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