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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05406219
• Other study ID #: 22044
• Status: Withdrawn
• Phase: Phase 1
• Start date: May 15, 2023
• Est. completion date: October 12, 2023

Study information

• Verified date: April 2023
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 12, 2023
• Est. primary completion date: August 17, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Diabetic Neuropathic Pain
• Healthy Volunteers
• Neuralgia
• Renal Impairment
• Renal Insufficiency

Intervention

Drug:
• BAY2395840
Immediate release (IR) tablet, oral administration

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Maximum observed drug concentration in measured matrix (Cmax) after single dose of BAY 2395840		From pre-dose up to 72 hours post administration
Primary	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
Primary	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	Number of participants with treatment-emergent adverse events (TEAEs)		From application of study intervention until follow-up Day 9

External Links

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