check_circleStudy Completed
Diabetic neuropathic pain, Healthy volunteers
Bayer Identifier:
21822
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
A study to learn how safe the study treatment BAY2395840 is, how it affects the body and how it moves into, through, and out of the body if given in single and in repetitive doses to Japanese healthy male participants
Trial purpose
Researchers are looking for a better way to treat people who have diabetic neuropathic pain (DNP).
DNP is pain due to damage to the nerves in the extremities that can occur in patients with diabetes as a result of blood sugar levels being too high for too long.
BAY2395840 works by blocking specific receptors. A receptor is a protein inside or on the surface of a cell that binds to a specific substance and causes a specific effect in the cell. BAY2395840 specifically blocks so-called bradykinin B1 receptor, whose activation is involved in inflammatory responses. This blockage may help to relieve pain and inflammation.
BAY2395840 has already been studied in clinical studies with European people. However, data for Japanese people are still missing. The participants of this study do not benefit from this study. However, the study will provide information on how to use BAY2395840 in later studies with Japanese people.
The main purpose of this study is to learn how safe the study drug BAY2395840 is and how it affects the body if given in single and in repetitive doses to Japanese healthy male participants.
To answer this question, the researchers will collect and analyze the medical problems the participants have after taking BAY2395840 and that may or may not be related to the study treatments. These medical problems are also known as “adverse events”.
In addition, the study team will learn how BAY2395840 moves into, through and out of the body if given in single and in repetitive doses to Japanese healthy male participants. For this, the researchers will collect data on:
• the (average) highest level of BAY2395840 in the blood (also referred to as Cmax)
• the (average) total level of BAY2395840 in the blood (also referred to as AUC)
during the treatment period with the study drug on day 1 and for the repetitive dose group only (see below), on day 7.
Subsequently, the study team will compare the data between those participants who received the study drug BAY2395840 (from different dosing groups) and those participants who received placebo. A placebo is a treatment that looks like a medicine but does not have any medicine in it.
All study participants will be randomly (by chance) assigned to 1 of 5 treatment groups. Dependent on the treatment group, the participants will either take:
• a single dose of the lowest, middle and highest BAY2395840 dose (treatment groups 1 to 3)
• repetitive doses of the highest BAY2395840 dose (treatment group 4) or
• placebo (treatment group 5).
The participants will take their treatments as dosage form 1 after diet 1. The treatment period with repetitive doses of BAY2395840 will be 7 subsequent days.
The participants from treatment groups 1 to 3 will have an in house-period of 8 days including 7 overnight stays. The participants from treatment group 4 will have an in house-period of 12 days including 11 overnight stays. The study duration will be approximately 6 weeks per participant for dose groups 1 to 3 and approximately 7 weeks per participant for dose group 4.
During the study, the study team will:
• take blood and urine samples
• do physical examinations
• check the vital signs such as blood pressure, heart rate, body temperature
• examine heart health using electrocardiogram (ECG).
About 10 to 14 days after the participants take their last treatment, the study doctors and their team will check the participants’ health.
DNP is pain due to damage to the nerves in the extremities that can occur in patients with diabetes as a result of blood sugar levels being too high for too long.
BAY2395840 works by blocking specific receptors. A receptor is a protein inside or on the surface of a cell that binds to a specific substance and causes a specific effect in the cell. BAY2395840 specifically blocks so-called bradykinin B1 receptor, whose activation is involved in inflammatory responses. This blockage may help to relieve pain and inflammation.
BAY2395840 has already been studied in clinical studies with European people. However, data for Japanese people are still missing. The participants of this study do not benefit from this study. However, the study will provide information on how to use BAY2395840 in later studies with Japanese people.
The main purpose of this study is to learn how safe the study drug BAY2395840 is and how it affects the body if given in single and in repetitive doses to Japanese healthy male participants.
To answer this question, the researchers will collect and analyze the medical problems the participants have after taking BAY2395840 and that may or may not be related to the study treatments. These medical problems are also known as “adverse events”.
In addition, the study team will learn how BAY2395840 moves into, through and out of the body if given in single and in repetitive doses to Japanese healthy male participants. For this, the researchers will collect data on:
• the (average) highest level of BAY2395840 in the blood (also referred to as Cmax)
• the (average) total level of BAY2395840 in the blood (also referred to as AUC)
during the treatment period with the study drug on day 1 and for the repetitive dose group only (see below), on day 7.
Subsequently, the study team will compare the data between those participants who received the study drug BAY2395840 (from different dosing groups) and those participants who received placebo. A placebo is a treatment that looks like a medicine but does not have any medicine in it.
All study participants will be randomly (by chance) assigned to 1 of 5 treatment groups. Dependent on the treatment group, the participants will either take:
• a single dose of the lowest, middle and highest BAY2395840 dose (treatment groups 1 to 3)
• repetitive doses of the highest BAY2395840 dose (treatment group 4) or
• placebo (treatment group 5).
The participants will take their treatments as dosage form 1 after diet 1. The treatment period with repetitive doses of BAY2395840 will be 7 subsequent days.
The participants from treatment groups 1 to 3 will have an in house-period of 8 days including 7 overnight stays. The participants from treatment group 4 will have an in house-period of 12 days including 11 overnight stays. The study duration will be approximately 6 weeks per participant for dose groups 1 to 3 and approximately 7 weeks per participant for dose group 4.
During the study, the study team will:
• take blood and urine samples
• do physical examinations
• check the vital signs such as blood pressure, heart rate, body temperature
• examine heart health using electrocardiogram (ECG).
About 10 to 14 days after the participants take their last treatment, the study doctors and their team will check the participants’ health.
Key Participants Requirements
Sex
MaleAge
20 - 45 YearsTrial summary
Enrollment Goal
24Trial Dates
October 2022 - February 2023Phase
Phase 1Could I Receive a placebo
NoProducts
BAY2395840Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | SOUSEIKAI Fukuoka Mirai Hospital | Fukuoka, 813-0017, Japan |
Primary Outcome
- Incidence of treatment emergent adverse events (TEAEs)date_rangeTime Frame:10 to 14 days after last administration of study intervention
Secondary Outcome
- Cmax (maximum observed drug concentration in measured matrix after single dose administration) of BAY2395840date_rangeTime Frame:On day 1
- AUC (area under the concentration vs. time curve from zero to infinity after single (first) dose) of BAY2395840AUC(0-tlast) will be used if AUC cannot be determined reliably in all participants. AUC(0-tlast): AUC from time 0 to the last data point >LLOQ (lower limit of quantification).date_rangeTime Frame:On day 1
- AUC(0-24) (AUC from time 0 to 24 h after single dosing) of BAY2395840date_rangeTime Frame:On day 1
- Cmax,md (Cmax after MD administration during a dosage interval, directly taken from analytical data) of BAY2395840 (only for Dose step 4)date_rangeTime Frame:On day 7
- AUC(0-24)md (AUC from time 0 to 24 h after multiple dosing) of BAY2395840 (only for Dose step 4)date_rangeTime Frame:On day 7
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
OtherAllocation
RandomizedBlinding
N/AAssignment
Sequential AssignmentTrial Arms
4