stop_circleTerminated/Withdrawn
Diabetic neuropathic pain, Renal impairment, Healthy volunteers
Bayer Identifier:
22044
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
Trial purpose
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.
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.
Key Participants Requirements
Sex
AllAge
18 YearsTrial summary
Enrollment Goal
0Trial Dates
May 2023 - October 2023Phase
Phase 1Could I Receive a placebo
NoProducts
BAY2395840Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Withdrawn | Clinical Pharmacology of Miami, LLC | Miami, 33014, United States |
Primary Outcome
- Area under the concentration vs. time curve from zero to infinity (AUC) after single dose of BAY 2395840AUC(0-tlast) will be used as the main parameter if AUC cannot be reliably determineddate_rangeTime Frame:From pre-dose up to 72 hours post administration
- Maximum observed drug concentration in measured matrix (Cmax) after single dose of BAY 2395840date_rangeTime Frame: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 2395840AUC(0-tlast)u will be used as the main parameter if AUC cannot be reliably determineddate_rangeTime Frame:From pre-dose up to 72 hours post administration
- Unbound maximum observed drug concentration in measured matrix (Cmax,u) after single dose of BAY 2395840date_rangeTime Frame:From pre-dose up to 72 hours post administration
Secondary Outcome
- Number of participants with treatment-emergent adverse events (TEAEs)date_rangeTime Frame:From application of study intervention until follow-up Day 9
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
Basic ScienceAllocation
Non-randomizedBlinding
N/AAssignment
Sequential AssignmentTrial Arms
3