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

NCT05406219 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: 22044
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Diabetic Neuropathic Pain; Renal Impairment; Healthy Volunteers

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Number of participants with treatment-emergent adverse events (TEAEs)

  From application of study intervention until follow-up Day 9

Study Arms (3)

Group 1: moderately impaired renal function

EXPERIMENTAL

Participants with moderately impaired renal function will receive a single dose of BAY2395840.

Drug: BAY2395840

Group 2: normal renal function matched to Group 1

EXPERIMENTAL

Participants with normal renal function matched to Group 1 will receive a single dose of BAY2395840.

Drug: BAY2395840

Group 3: normal renal function aiming to balance out Group 2

EXPERIMENTAL

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

Interventions

BAY2395840 DRUG

Immediate release (IR) tablet, oral administration

Group 1: moderately impaired renal function; Group 2: normal renal function matched to Group 1; Group 3: normal renal function aiming to balance out Group 2

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Bayer: lead

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

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

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

Study Record Dates

• First Submitted: June 1, 2022
• First Posted: June 6, 2022
• Study Start: May 15, 2023
• Primary Completion: August 17, 2023
• Study Completion: October 12, 2023
• Last Updated: April 19, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share