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

NCT04471337 | Completed Phase 1 FDA Drug

• 1 other identifier: 20332
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (2)

• AUCu after single dose of BAY1817080

  AUCu: Area under the Curve unbound

  On Day 1

• Cmax,u after single dose of BAY1817080

  Cmax,u: maximum observed drug concentration in measured matrix after single dose administration (unbound)

  On Day 1

Secondary Outcomes (3)

• Number of subjects with treatment emergent adverse events (TEAEs)

  From dosing up to 14 days after end of treatment with study medication

• AUC (0-12)md,u after multiple dose of BAY1817080

  From Day 6 to Day 13

• Cmax,md,u after multiple dose of BAY1817080

  From Day 6 to Day 13

Study Arms (4)

Arm A: Moderately impaired renal function

EXPERIMENTAL

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

Drug: BAY1817080

Arm B: Normal renal function matched to Arm A

EXPERIMENTAL

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

Drug: BAY1817080

Arm C: End stage renal disease on dialysis

EXPERIMENTAL

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

Drug: BAY1817080

Arm D: Normal renal function matched to Arm C

EXPERIMENTAL

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

Drug: BAY1817080

Interventions

BAY1817080 DRUG

BAY1817080 will be administered orally as tablet.

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

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (2)

Clinical Pharmacology of Miami, LLC

Miami, Florida, 33014, United States

Location

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

Related Links

• 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.

MeSH Terms

Conditions

Urinary Bladder, Overactive; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Chronic Disease; Disease Attributes; Pathologic Processes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2020
• First Posted: July 15, 2020
• Study Start: August 12, 2020
• Primary Completion: February 15, 2021
• Study Completion: May 6, 2021
• Last Updated: March 26, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)