Diabetic Neuropathic PainPhase 1NCT05406219
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
A Phase 1 study testing BAY2395840 in people with Diabetic Neuropathic Pain and Renal Impairment, run by Bayer.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetic Neuropathic Pain, Renal Impairment, Healthy Volunteers
- What is being tested?
- BAY2395840
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2023to 12 Oct 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
About this study
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
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.
Read more
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.
- Being tested
- BAY2395840
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY2395840Drug
Immediate release (IR) tablet, oral administration
| Study group | Role | What they receive |
|---|---|---|
| Group 1: moderately impaired renal function | Experimental | Participants with moderately impaired renal function will receive a single dose of BAY2395840. Receives: Drug: BAY2395840 |
| Group 2: normal renal function matched to Group 1 | Experimental | Participants with normal renal function matched to Group 1 will receive a single dose of BAY2395840. Receives: Drug: BAY2395840 |
| Group 3: normal renal function aiming to balance out Group 2 | Experimental | Participants with normal renal function aiming to balance out Group 2 for the age and gender investigations will receive a single dose of BAY2395840. Receives: Drug: BAY2395840 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From pre-dose up to 72 hours post administration
Maximum observed drug concentration in measured matrix (Cmax) after single dose of BAY 2395840
Measured: 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 2395840
AUC(0-tlast)u will be used as the main parameter if AUC cannot be reliably determined
Measured: From pre-dose up to 72 hours post administration
Unbound maximum observed drug concentration in measured matrix (Cmax,u) after single dose of BAY 2395840
Measured: From pre-dose up to 72 hours post administration
Secondary outcomes (1)
Number of participants with treatment-emergent adverse events (TEAEs)
Measured: From application of study intervention until follow-up Day 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2022
- Study start15 May 2023 (estimated)
- Primary completion17 Aug 2023 (estimated)
- Study completion12 Oct 2023 (estimated)
Why it stopped: Discontinuation of program.
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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05406219
- Sponsor's protocol ID
- 22044
- Status last verified
- Apr 2023
- First submitted
- 1 Jun 2022
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- 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 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05406219
- Acronym / sponsor ID
- 22044
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Discontinuation of program.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 15 May 2023 (estimated)
- Primary completion
- 17 Aug 2023 (estimated)
- Study completion
- 12 Oct 2023 (estimated)
- First posted
- 6 Jun 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 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: moderately impaired renal function | Experimental | Drug: BAY2395840Participants with moderately impaired renal function will receive a single dose of BAY2395840. |
| Group 2: normal renal function matched to Group 1 | Experimental | Drug: BAY2395840Participants with normal renal function matched to Group 1 will receive a single dose of BAY2395840. |
| Group 3: normal renal function aiming to balance out Group 2 | Experimental | Drug: BAY2395840Participants with normal renal function aiming to balance out Group 2 for the age and gender investigations will receive a single dose of BAY2395840. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (3 listed)
- 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).
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 |
|---|---|---|
| BAY2395840Immediate release (IR) tablet, oral administration | Drug | Group 1: moderately impaired renal function, Group 2: normal renal function matched to Group 1, Group 3: normal renal function aiming to balance out Group 2 |
Primary outcome
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
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
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
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
1 secondary outcome
Number of participants with treatment-emergent adverse events (TEAEs)
Time frame: From application of study intervention until follow-up Day 9
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BAY2395840 in people with Diabetic Neuropathic Pain and Renal Impairment, run by Bayer.
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 7 inclusion and 3 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: withdrawn, as of the sponsor's last update on 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
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). The study lists 4 primary outcomes in all. 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 19 Apr 2023.