Chronic Kidney DiseasePhase 1NCT06487845
A Study to Learn How Safe BAY3283142 is When Taken as a Single Dose or as Multiple Doses in Healthy Chinese Participants
A Phase 1 study testing BAY3283142 in people with Chronic Kidney Disease and Non-proliferative Diabetic Retinopathy, run by Bayer at 1 site in China.
Trial summary
Researchers are looking for a better way to treat people who have chronic kidney disease (CKD) or non-proliferative diabetes retinopathy (NPDR). CKD is a long-term condition in which the ability of the kidneys to work decreases over time. It is often caused by high blood glucose levels. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease, Non-proliferative Diabetic Retinopathy, Healthy Volunteers
- What is being tested?
- BAY3283142
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 4 Jul 2024to 19 Sep 2024
- 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants must be 18 to 45 years of age (both inclusive) at the time of signing the informed consent.
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory test and 12-lead ECG.
- Race: Chinese
- Body mass index (BMI) within the range 18.0 - 27.9 kg/m² (both inclusive) at screening.
- Body weight of at least 55 kg at screening.
- Male and female, female only allowed in the 5 mg dose group. Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Who cannot join
- Known tendency for vasovagal reactions (e.g., after venipuncture) or history of syncope.
- Systolic blood pressure below 100 mmHg or above 140 mmHg (after 15 minutes of supine rest) at screening.
- Diastolic blood pressure below 60 mmHg or above 90 mmHg (after 15 minutes of supine rest) at screening.
- Heart rate below 50 or above 90 beats per minute (after 15 minutes of supine rest) at screening.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Guangzhou University of TCM
Guangzhou, Guangdong, 510405
About this study
Official title: Single and Multiple Dose Escalation Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BAY 3283142 Given as Immediate Release (IR) Tablets in Chinese Healthy Participants in a Randomized, Placebo-controlled, Single-blind, Group-comparison Design
Researchers are looking for a better way to treat people who have chronic kidney disease (CKD) or non-proliferative diabetes retinopathy (NPDR). CKD is a long-term condition in which the ability of the kidneys to work decreases over time. It is often caused by high blood glucose levels. NPDR is another condition in which high blood glucose levels cause damage to the blood vessels of the retina, which is a tissue at the back of the eyes.
The study drug BAY3283142 works by activating a protein called soluble guanylate cyclase, which helps widen the blood vessels and regulate blood flow inside the body. This may help increase the blood flow in the kidneys and improve their function. It could also help to restore blood flow to the retina.
Read more
This study will include healthy participants who will not benefit from taking BAY3283142. However, the study will provide information on how to test BAY3283142 in future studies in participants with CKD or NPDR.
The main purpose of this study is to check how safe single and multiple doses of BAY3283142 are in healthy Chinese participants.
For this, researchers will collect the number and percentage of participants who have medical problems, which are also known as 'adverse events', after taking BAY3283142 or a placebo. A placebo looks like the study treatment but does not have any medicine in it.
The study doctor will keep track of all adverse events that happen in the study, even if they are not related to the study treatments.
The participants will be randomly divided into 2 treatment groups. They will take either BAY3283142 as an immediate-release tablet, or a placebo tablet, once, by mouth, based on the group assigned to them. An immediate-release tablet quickly dissolves and releases the drug inside the body.
Participants will have a one-day break after taking the single dose and then continue taking their assigned treatment once daily for a week. Researchers will check two different dose strengths of BAY3283142 in this study, starting with a low dose first.
Each participant will be in the study for around 7 weeks, which includes:
A visit within 21 days before the first dose to confirm if the participant can take part in the study
A hospital stay of 15 days during which the participant will take the assigned study treatment and the study doctor will monitor the participant's health
A visit after 7 to 10 days of taking the last dose during which the study doctor will perform a health check-up of the participant
During the study, the study doctor and his/her team will:
Test participants' blood and urine samples and check their overall health
Monitor participants' heart health by electrocardiogram (ECG) and measure their blood pressure and heart rate
As this study is conducted in healthy participants who will not gain any benefit from the treatment, access to the treatment after the study is not planned.
- Being tested
- BAY3283142, Placebo
- Keywords
- CKD, NPDR
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY3283142Drug
IR tablets, oral
PlaceboDrug
Placebo matched to BAY3283142
| Study group | Role | What they receive |
|---|---|---|
| Dose step 1 | Experimental | Participants will receive a low dose of BAY3283142 on Day 1 followed by 1 day without dosing and a multiple dose phase for 7 days. Receives: Drug: BAY3283142 |
| Dose step 2 | Experimental | Participants will receive a high dose of BAY3283142 on Day 1 followed by 1 day without dosing and a multiple dose phase for 7 days. Receives: Drug: BAY3283142 |
| Placebo | Placebo comparator | Participants will receive placebo on Day 1 followed by 1 day without dosing and a multiple dose phase for 7 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment emergent adverse event (TEAEs)
Measured: From first study intervention administration until [including] 7 days after end of treatment with study intervention (approximately 25 days)
Percentage of participants with treatment emergent adverse event (TEAEs)
Measured: From first study intervention administration until [including] 7 days after end of treatment with study intervention (approximately 25 days)
Secondary outcomes (8)
AUC of BAY3283142
AUC: Area under the concentration vs. Time curve from zero to infinity after single (first) dose
Measured: 0 to 48 hours post-dose after the first dose on Day 1
Cmax of BAY3283142
Cmax: Maximum observed drug concentration in measured matrix after single dose administration, directly taken from analytical data
Measured: 0 to 48 hours post-dose after the first dose on Day 1
AUC/D of BAY3283142
AUC/D: AUC divided by dose
Measured: 0 to 48 hours post-dose after the first dose on Day 1
Cmax/D of BAY3283142
Cmax/D: Cmax devided by dose
Measured: 0 to 48 hours post-dose after the first dose on Day 1
AUCτ,md of BAY3283142
AUCτ,md: AUC during any dose interval after multiple dose
Measured: 0 to 24 hours post-dose after the last dose on Day 9
Cmax,md of BAY3283142
Cmax,md: Maximum observed drug concentration in measured matrix after multiple dose administration during a dosage interval, directly taken from analytical data
Measured: 0 to 24 hours post-dose after the last dose on Day 9
AUCτ,md/D of BAY3283142
AUCτ,md/D: AUC during any dose interval after multiple dose divided by dose
Measured: 0 to 24 hours post-dose after the last dose on Day 9
Cmax,md/D of BAY3283142
Cmax,md/D: Cmax,md divided by dose
Measured: 0 to 24 hours post-dose after the last dose on Day 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start4 Jul 2024
- Primary completion19 Sep 2024
- Study completion19 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies 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
- Parallel groups
- 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
- NCT06487845
- Sponsor's protocol ID
- 22420
- Status last verified
- Sep 2024
- First submitted
- 24 Jun 2024
- Last updated
- 24 Sep 2024
- 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 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single and Multiple Dose Escalation Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BAY 3283142 Given as Immediate Release (IR) Tablets in Chinese Healthy Participants in a Randomized, Placebo-controlled, Single-blind, Group-comparison Design
- ClinicalTrials.gov ID
- NCT06487845
- Acronym / sponsor ID
- 22420
- Keywords
- CKD, NPDR
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 4 Jul 2024 (actual)
- Primary completion
- 19 Sep 2024 (actual)
- Study completion
- 19 Sep 2024 (actual)
- First posted
- 5 Jul 2024 (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 chronic kidney disease (CKD) or non-proliferative diabetes retinopathy (NPDR). CKD is a long-term condition in which the ability of the kidneys to work decreases over time. It is often caused by high blood glucose levels. NPDR is another condition in which high blood glucose levels cause damage to the blood vessels of the retina, which is a tissue at the back of the eyes.
The study drug BAY3283142 works by activating a protein called soluble guanylate cyclase, which helps widen the blood vessels and regulate blood flow inside the body. This may help increase the blood flow in the kidneys and improve their function. It could also help to restore blood flow to the retina.
This study will include healthy participants who will not benefit from taking BAY3283142. However, the study will provide information on how to test BAY3283142 in future studies in participants with CKD or NPDR.
The main purpose of this study is to check how safe single and multiple doses of BAY3283142 are in healthy Chinese participants.
For this, researchers will collect the number and percentage of participants who have medical problems, which are also known as 'adverse events', after taking BAY3283142 or a placebo. A placebo looks like the study treatment but does not have any medicine in it.
The study doctor will keep track of all adverse events that happen in the study, even if they are not related to the study treatments.
The participants will be randomly divided into 2 treatment groups. They will take either BAY3283142 as an immediate-release tablet, or a placebo tablet, once, by mouth, based on the group assigned to them. An immediate-release tablet quickly dissolves and releases the drug inside the body.
Participants will have a one-day break after taking the single dose and then continue taking their assigned treatment once daily for a week. Researchers will check two different dose strengths of BAY3283142 in this study, starting with a low dose first.
Each participant will be in the study for around 7 weeks, which includes:
A visit within 21 days before the first dose to confirm if the participant can take part in the study
A hospital stay of 15 days during which the participant will take the assigned study treatment and the study doctor will monitor the participant's health
A visit after 7 to 10 days of taking the last dose during which the study doctor will perform a health check-up of the participant
During the study, the study doctor and his/her team will:
Test participants' blood and urine samples and check their overall health
Monitor participants' heart health by electrocardiogram (ECG) and measure their blood pressure and heart rate
As this study is conducted in healthy participants who will not gain any benefit from the treatment, access to the treatment after the study is not planned.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose step 1 | Experimental | Drug: BAY3283142Participants will receive a low dose of BAY3283142 on Day 1 followed by 1 day without dosing and a multiple dose phase for 7 days. |
| Dose step 2 | Experimental | Drug: BAY3283142Participants will receive a high dose of BAY3283142 on Day 1 followed by 1 day without dosing and a multiple dose phase for 7 days. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo on Day 1 followed by 1 day without dosing and a multiple dose phase for 7 days. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Participants must be 18 to 45 years of age (both inclusive) at the time of signing the informed consent.
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory test and 12-lead ECG.
- Race: Chinese
- Body mass index (BMI) within the range 18.0 - 27.9 kg/m² (both inclusive) at screening.
- Body weight of at least 55 kg at screening.
Key exclusion criteria (4 listed)
- Known tendency for vasovagal reactions (e.g., after venipuncture) or history of syncope.
- Systolic blood pressure below 100 mmHg or above 140 mmHg (after 15 minutes of supine rest) at screening.
- Diastolic blood pressure below 60 mmHg or above 90 mmHg (after 15 minutes of supine rest) at screening.
- Heart rate below 50 or above 90 beats per minute (after 15 minutes of supine rest) at screening.
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 |
|---|---|---|
| BAY3283142IR tablets, oral | Drug | Dose step 1, Dose step 2 |
| PlaceboPlacebo matched to BAY3283142 | Drug | Placebo |
Primary outcome
Number of participants with treatment emergent adverse event (TEAEs)
Time frame: From first study intervention administration until [including] 7 days after end of treatment with study intervention (approximately 25 days)
Percentage of participants with treatment emergent adverse event (TEAEs)
Time frame: From first study intervention administration until [including] 7 days after end of treatment with study intervention (approximately 25 days)
8 secondary outcomes
AUC of BAY3283142
Time frame: 0 to 48 hours post-dose after the first dose on Day 1
Cmax of BAY3283142
Time frame: 0 to 48 hours post-dose after the first dose on Day 1
AUC/D of BAY3283142
Time frame: 0 to 48 hours post-dose after the first dose on Day 1
Cmax/D of BAY3283142
Time frame: 0 to 48 hours post-dose after the first dose on Day 1
AUCτ,md of BAY3283142
Time frame: 0 to 24 hours post-dose after the last dose on Day 9
Cmax,md of BAY3283142
Time frame: 0 to 24 hours post-dose after the last dose on Day 9
AUCτ,md/D of BAY3283142
Time frame: 0 to 24 hours post-dose after the last dose on Day 9
Cmax,md/D of BAY3283142
Time frame: 0 to 24 hours post-dose after the last dose on Day 9
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 24 Sep 2024.
- 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 BAY3283142 in people with Chronic Kidney Disease and Non-proliferative Diabetic Retinopathy, run by Bayer at 1 site in China.
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 6 inclusion and 4 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 24 Sep 2024. 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 China. 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. Some participants in this study may receive a placebo. 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?
Number of participants with treatment emergent adverse event (TEAEs) (time frame: From first study intervention administration until [including] 7 days after end of treatment with study intervention (approximately 25 days)). The study lists 2 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 24 Sep 2024; AzTrials last refreshed its copy on 31 Oct 2026.