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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

Primary Purpose

Endometriosis Related Pain, Overactive Bladder, Diabetic Neuropathic Pain

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BAY1817080
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Endometriosis Related Pain focused on measuring Normal renal function, Moderate renal impairment, End stage renal disease (ESRD), Dialysis

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Clinical Pharmacology of Miami, LLC
  • Orlando Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Arm A: Moderately impaired renal function

Arm B: Normal renal function matched to Arm A

Arm C: End stage renal disease on dialysis

Arm D: Normal renal function matched to Arm C

Arm Description

Participants with moderately impaired renal function will receive multiple doses of BAY1817080.

Participants with normal renal function matched to Arm A will receive multiple doses of BAY1817080.

Participants with ESRD requiring dialysis will receive single dose of BAY1817080.

Participants with normal renal function matched to Arm C will receive single dose of BAY1817080.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of subjects with treatment emergent adverse events (TEAEs)
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)
Cmax,md,u after multiple dose of BAY1817080
Cmax,md,u: Maximum observed drug concentration at steady state for multiple dose (unbound)

Full Information

First Posted
July 10, 2020
Last Updated
January 24, 2023
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT04471337
Brief Title
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
August 12, 2020 (Actual)
Primary Completion Date
February 15, 2021 (Actual)
Study Completion Date
May 6, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A: Moderately impaired renal function
Arm Type
Experimental
Arm Description
Participants with moderately impaired renal function will receive multiple doses of BAY1817080.
Arm Title
Arm B: Normal renal function matched to Arm A
Arm Type
Experimental
Arm Description
Participants with normal renal function matched to Arm A will receive multiple doses of BAY1817080.
Arm Title
Arm C: End stage renal disease on dialysis
Arm Type
Experimental
Arm Description
Participants with ESRD requiring dialysis will receive single dose of BAY1817080.
Arm Title
Arm D: Normal renal function matched to Arm C
Arm Type
Experimental
Arm Description
Participants with normal renal function matched to Arm C will receive single dose of BAY1817080.
Intervention Type
Drug
Intervention Name(s)
BAY1817080
Intervention Description
BAY1817080 will be administered orally as tablet.
Primary Outcome Measure Information:
Title
AUCu after single dose of BAY1817080
Description
AUCu: Area under the Curve unbound
Time Frame
On Day 1
Title
Cmax,u after single dose of BAY1817080
Description
Cmax,u: maximum observed drug concentration in measured matrix after single dose administration (unbound)
Time Frame
On Day 1
Secondary Outcome Measure Information:
Title
Number of subjects with treatment emergent adverse events (TEAEs)
Time Frame
From dosing up to 14 days after end of treatment with study medication
Title
AUC (0-12)md,u after multiple dose of BAY1817080
Description
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
Title
Cmax,md,u after multiple dose of BAY1817080
Description
Cmax,md,u: Maximum observed drug concentration at steady state for multiple dose (unbound)
Time Frame
From Day 6 to Day 13

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Clinical Pharmacology of Miami, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Orlando Clinical Research Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There are no current plans to share data. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Links:
URL
http://clinicaltrials.bayer.com/
Description
Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.

Learn more about this trial

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

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