The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05406219
Recruitment Status : Withdrawn (Discontinuation of program.)
First Posted : June 6, 2022
Last Update Posted : April 19, 2023
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Diabetic Neuropathic Pain Renal Impairment Healthy Volunteers Drug: BAY2395840 Phase 1

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Estimated Study Start Date : May 15, 2023
Estimated Primary Completion Date : August 17, 2023
Estimated Study Completion Date : October 12, 2023
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Area under the concentration vs. time curve from zero to infinity (AUC) after single dose of BAY 2395840 [ Time Frame: From pre-dose up to 72 hours post administration ]
    AUC(0-tlast) will be used as the main parameter if AUC cannot be reliably determined

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

  4. Unbound maximum observed drug concentration in measured matrix (Cmax,u) after single dose of BAY 2395840 [ Time Frame: From pre-dose up to 72 hours post administration ]

Secondary Outcome Measures :
  1. Number of participants with treatment-emergent adverse events (TEAEs) [ Time Frame: From application of study intervention until follow-up Day 9 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

No Contacts or Locations Provided
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT05406219    
Other Study ID Numbers: 22044
First Posted: June 6, 2022    Key Record Dates
Last Update Posted: April 19, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Neuralgia
Renal Insufficiency
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
 Kidney Diseases
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases