Diabetic Neuropathic PainPhase 1NCT05563454
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
A Phase 1 study testing BAY2395840 in people with Diabetic Neuropathic Pain and Healthy Volunteers, run by Bayer at 1 site in Japan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetic Neuropathic Pain, Healthy Volunteers
- What is being tested?
- BAY2395840
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteJapan
- Study dates
- 11 Oct 2022to 28 Feb 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, vital signs (BP and pulse rate), 12-lead ECG, and laboratory tests. Re-screening will be allowed.
- Ethnicity: Japanese
- Participant must be 20 to 45 years of age inclusive, at the time of signing the informed consent.
- BMI above or equal 18.0 kg/m^2 and below or equal 29.9 kg/m^2 at screening
- Male
- Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Study participants of reproductive potential must agree to use adequate contraception when sexually active. This applies for the time period between signing of the ICF and 90 days after administration of the study intervention. Acceptable methods of contraception include, but are not limited to: (i) condoms (male or female); (ii) intra-uterine device; (iii) hormone-based contraception. Study participants of reproductive potential must agree to utilize 2 reliable and acceptable methods of contraception simultaneously including condoms.
- A sexually active man who has not been surgically sterilized has to agree not to act as sperm donor for the time period between signing of the ICF and 90 days after the last administration of study intervention.
Who cannot join
- Any findings from the medical examination (including medical history, physical examination, vital signs, laboratory tests, and 12-lead ECG) deviating from normal and deemed to be of clinical relevance by the investigator.
- Relevant diseases within the last 4 weeks prior to first administration of study intervention.
- Known severe allergies.
- Regular use of therapeutic or recreational drugs.
- Suspicion of drug or alcohol abuse.
- Positive cotinine test.
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- Donation of more than 200 mL of blood within 4 weeks before first administration of study intervention, donation of more than 400 mL of blood within 3 months before first administration of study intervention, or plasmapheresis within 3 months prior to first administration of study intervention.
- Intake of foods or beverages containing grapefruit, pomelo, tangelo, or Seville oranges from 7 days before first administration of the study intervention up to the last time point of PK sampling after the last administration of the study intervention.
- Special diets preventing the participants from eating the standard meals during the study conduct.
- Participation in a clinical study of an investigational drug within 4 months or of an approved drug within 3 months before the first administration of study intervention.
- Criteria which in the opinion of the investigator preclude participation for scientific reasons, for reasons of compliance, or for reasons of the participant's safety.
- Participant is in custody by order of an authority or a court of law.
- Participant is an employee of the sponsor or of a CRO conducting the study, or has a close affiliation with the investigational site.
- Unable/unwilling to comply with study restrictions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Placebo-controlled, Single-blind, Dose Escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics of BAY 2395840 After Single and Multiple Dose in Japanese Healthy Male Participants
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.
Read more
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.
- Conditions
- Diabetic Neuropathic Pain, Healthy Volunteers
- Being tested
- BAY2395840
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY2395840Drug
Administration of dosage form 1 under diet 1 condition
| Study group | Role | What they receive |
|---|---|---|
| Dose step 1 | Experimental | Each participant will receive an single dose (SD) of dose 1 of BAY2395840 or matching placebo. Receives: Drug: BAY2395840 |
| Dose step 2 | Experimental | Each participant will receive an single dose (SD) of dose 2 of BAY2395840 or matching placebo. Receives: Drug: BAY2395840 |
| Dose step 3 | Experimental | Each participant will receive an single dose (SD) of dose 3 of BAY2395840 or matching placebo. Receives: Drug: BAY2395840 |
| Dose step 4 | Experimental | Each participant will receive multiple doses (MDs) of dose 3 of BAY2395840 or matching placebo. Receives: Drug: BAY2395840 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment emergent adverse events (TEAEs)
Measured: 10 to 14 days after last administration of study intervention
Secondary outcomes (5)
Cmax (maximum observed drug concentration in measured matrix after single dose administration) of BAY2395840
Measured: On day 1
AUC (area under the concentration vs. time curve from zero to infinity after single (first) dose) of BAY2395840
AUC(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).
Measured: On day 1
AUC(0-24) (AUC from time 0 to 24 h after single dosing) of BAY2395840
Measured: 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)
Measured: On day 7
AUC(0-24)md (AUC from time 0 to 24 h after multiple dosing) of BAY2395840 (only for Dose step 4)
Measured: On day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start11 Oct 2022
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Neuropathic PainStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05563454
- Sponsor's protocol ID
- 21822
- Status last verified
- Mar 2023
- First submitted
- 29 Sep 2022
- Last updated
- 15 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled, Single-blind, Dose Escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics of BAY 2395840 After Single and Multiple Dose in Japanese Healthy Male Participants
- ClinicalTrials.gov ID
- NCT05563454
- Acronym / sponsor ID
- 21822
- Conditions
- Diabetic Neuropathic Pain, Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 11 Oct 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 3 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dose step 1 | Experimental | Drug: BAY2395840Each participant will receive an single dose (SD) of dose 1 of BAY2395840 or matching placebo. |
| Dose step 2 | Experimental | Drug: BAY2395840Each participant will receive an single dose (SD) of dose 2 of BAY2395840 or matching placebo. |
| Dose step 3 | Experimental | Drug: BAY2395840Each participant will receive an single dose (SD) of dose 3 of BAY2395840 or matching placebo. |
| Dose step 4 | Experimental | Drug: BAY2395840Each participant will receive multiple doses (MDs) of dose 3 of BAY2395840 or matching placebo. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, vital signs (BP and pulse rate), 12-lead ECG, and laboratory tests. Re-screening will be allowed.
- Ethnicity: Japanese
- Participant must be 20 to 45 years of age inclusive, at the time of signing the informed consent.
- BMI above or equal 18.0 kg/m^2 and below or equal 29.9 kg/m^2 at screening
- Male
Key exclusion criteria (14 listed)
- Any findings from the medical examination (including medical history, physical examination, vital signs, laboratory tests, and 12-lead ECG) deviating from normal and deemed to be of clinical relevance by the investigator.
- Relevant diseases within the last 4 weeks prior to first administration of study intervention.
- Known severe allergies.
- Regular use of therapeutic or recreational drugs.
- Suspicion of drug or alcohol abuse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BAY2395840Administration of dosage form 1 under diet 1 condition | Drug | Dose step 1, Dose step 2, Dose step 3, Dose step 4 |
Primary outcome
Incidence of treatment emergent adverse events (TEAEs)
Time frame: 10 to 14 days after last administration of study intervention
5 secondary outcomes
Cmax (maximum observed drug concentration in measured matrix after single dose administration) of BAY2395840
Time frame: On day 1
AUC (area under the concentration vs. time curve from zero to infinity after single (first) dose) of BAY2395840
Time frame: On day 1
AUC(0-24) (AUC from time 0 to 24 h after single dosing) of BAY2395840
Time 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)
Time 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)
Time frame: On day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BAY2395840 in people with Diabetic Neuropathic Pain and Healthy Volunteers, run by Bayer at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment emergent adverse events (TEAEs) (time frame: 10 to 14 days after last administration of study intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2023.