A Study to Learn How the Study Treatment BAY2395840 Moves Into, Through and Out of the Body, How Safe it is, and How it Affects the Body in Participants With Moderate Reduced Kidney Function and in Healthy Male and Female Participants With Normal Kidney Function

An Open-label, Single-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BAY 2395840 in Participants With Moderate Renal Impairment and in Healthy Male and Female Participants With Normal Renal Function

Researchers are looking for a better way to treat people who have inflammatory conditions.

Inflammatory conditions may result from an increased activation of the body's natural defenses (the immune system) and are characterized by swelling, redness, heat, and pain.

The study treatment BAY2395840 is under development for use in inflammatory conditions. It works by blocking a protein, the B1 receptor, whose activation is involved in inflammatory responses.

The main purpose of this study is to learn how a single dose of BAY2395840 moves into, through and out of the body in participants with a moderate reduction of kidney function compared to matched participants with normal kidney function.

To answer this, the researchers will compare:

• the (average) total level of BAY2395840 in the blood (also known as AUC), and
• the (average) highest level of BAY2395840 in the blood (also known as Cmax) between the two groups of participants. The participants do not benefit from this study. However, the study will provide information on how to use BAY2395840 in later studies in people with inflammatory conditions. As some people with these conditions may also have kidney problems, this study is done in participants with moderate reduction of kidney function to characterize the use of BAY2395840 in this patient group.

All participants will take a single dose of BAY2395840 as tablets. Each participant will be in the study for up to 5 weeks. They will stay in-house for 4 days, including one treatment day. In addition, one visit before and one visit after the in-house phase to the study site is planned.

Study Overview

• Status: Withdrawn
• Conditions: Renal Impairment; Healthy Volunteers; Diabetic Neuropathic Pain
• Intervention / Treatment: Drug: BAY2395840

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33014
      • Clinical Pharmacology of Miami, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Participants must be 18 years of age or older, at the time of signing the informed consent.
• Participants who are - apart from renal function - overtly healthy for their age as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
• Participants with moderate renal impairment with an eGFR of 30 to 59 mL/min/1.73 m^2 (inclusive) according to the Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI)
• Normal renal function, as assessed by estimated glomerular filtration rate (eGFR) based on serum creatinine at screening according to the modified Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI) formula: eGFR ≥90 mL/min/1.73 m^2. For participants with an age of 65 years and older, an eGFR of ≥ 60 mL/min/1.73 m^2 is acceptable.
• Body mass index (BMI) within the range 18 - 32 kg/m^2 (inclusive).
• Male and female participants had to use safe contraception, as defined by guidelines for contraception in clinical studies.
• Capable of giving signed informed consent.

Exclusion Criteria:

• Medical disorder, condition or history of such that would impair the participant's ability to take part in or complete this study.
• Acute renal failure or acute nephritis within the past 2 years.
• Existing chronic diseases requiring medication (applicable only for Group 2 and Group 3 for those younger than 65 years).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: moderately impaired renal function; Participants with moderately impaired renal function will receive a single dose of BAY2395840.	Drug: BAY2395840; Immediate release (IR) tablet, oral administration
Experimental: Group 2: normal renal function matched to Group 1; Participants with normal renal function matched to Group 1 will receive a single dose of BAY2395840.	Drug: BAY2395840; Immediate release (IR) tablet, oral administration
Experimental: Group 3: normal renal function aiming to balance out Group 2; Participants with normal renal function aiming to balance out Group 2 for the age and gender investigations will receive a single dose of BAY2395840.	Drug: BAY2395840; Immediate release (IR) tablet, oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the concentration vs. time curve from zero to infinity (AUC) after single dose of BAY 2395840	AUC(0-tlast) will be used as the main parameter if AUC cannot be reliably determined	From pre-dose up to 72 hours post administration
Maximum observed drug concentration in measured matrix (Cmax) after single dose of BAY 2395840		From pre-dose up to 72 hours post administration
Unbound area under the concentration vs. time curve from zero to infinity (AUCu) after single (first) dose of BAY 2395840	AUC(0-tlast)u will be used as the main parameter if AUC cannot be reliably determined	From pre-dose up to 72 hours post administration
Unbound maximum observed drug concentration in measured matrix (Cmax,u) after single dose of BAY 2395840		From pre-dose up to 72 hours post administration

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of participants with treatment-emergent adverse events (TEAEs)	From application of study intervention until follow-up Day 9

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): May 15, 2023
• Primary Completion (Anticipated): August 17, 2023
• Study Completion (Anticipated): October 12, 2023

Study Registration Dates

• First Submitted: June 1, 2022
• First Submitted That Met QC Criteria: June 1, 2022
• First Posted (Actual): June 6, 2022

Study Record Updates

• Last Update Posted (Actual): April 19, 2023
• Last Update Submitted That Met QC Criteria: April 17, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Kidney Diseases; Urologic Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia; Renal Insufficiency
• Other Study ID Numbers: 22044

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No