Chronic Kidney DiseasePhase 1NCT05800444
A Study to Learn How Safe the Study Treatment BAY3283142 is, How it Affects the Body, How it Moves Into, Through and Out of the Body When Single and Multiple Amounts Are Taken as Tablets in Japanese Healthy Male Participants
A Phase 1 study testing BAY3283142 in people with Chronic Kidney Disease 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 chronic kidney disease (CKD). The kidneys filter extra water and waste out of the blood and make urine. CKD is a long-term, progressive decrease in the kidneys' ability to work properly. Read more about this study
- Who is it for?
- Ages 20 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease, 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 siteJapan
- Study dates
- 3 Apr 2023to 19 Jul 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant must be 20 to 50 years of age 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 tests, and 12 lead ECG.
- Race: Japanese.
- body mass index (BMI) within the range 18.0 and 29.9 kg/m^2 (inclusive).
- Body weight equal or above 55 kg (inclusive).
- Male: Contraceptive use by men and female partners of male participants should be consistent with local regulations regarding the methods of contraception for those participating 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 participate or complete this study in the opinion of the investigator.
- A history of clinically relevant diseases of any organs.
- Pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination, and effects of the study interventions will not be normal.
- Participants with thyroid disorders as evidenced by assessment of thyroid stimulating hormone levels outside the normal reference range.
- Known hypersensitivity to the study interventions (active substances or excipients of the preparations, e.g., lactose).
- Known severe allergies (e.g., allergies to more than 3 allergens, allergies affecting the lower respiratory tract - allergic asthma, allergies requiring therapy with corticosteroids), urticaria or significant non-allergic drug reactions.
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- Relevant diseases within the last 4 weeks prior to the first intake of study intervention.
- Febrile illness within 2 weeks before the first intake of study intervention.
- Known tendency for vasovagal reactions (e.g., after venipuncture) or history of syncope.
- History of gastrointestinal surgery, with the exception of appendectomy (surgery at least 12 months before screening) and inguinal hernia repair (the surgery at least 12 months before screening with the documentation of no intestine necrosis and no intestine segment resection, and participants must be fully recovered and have no signs or symptoms).
- Acute diarrhea or constipation within 14 days before the first intake of study intervention.
- Regular use of medicines.
- Use of any other systemic or topical medicines or substances which oppose the study objectives.
- Regular use of therapeutic or recreational drugs, e.g., carnitine products, anabolics, high dose vitamins.
- Excluded therapies (e.g., physiotherapy, acupuncture, etc.) within 1 week before the first intake of study intervention.
- Participation in another clinical study of an investigational drug (last dose) within 90 days or 5 half lives of the investigational drug, whichever is longer, before the first dose of this study.
- Exclusion periods from other studies or simultaneous participation in other clinical studies.
- Previous treatment during this study (allowing previously treated participants to be re included into the study may lead to bias).
- Clinically relevant findings in the 12-lead ECG such as a second- or third-degree atrioventricular block, prolongation of the QRS complex over or equal to 120 msec, or of the QTcF or QTcB intervals over 450 msec.
- Clinically relevant arrhythmic disturbances as found in the 12-lead ECGs (especially repeated supra- and ventricular ectopic beats - Lown classification grade 2 or more); known congenital QT prolongation.
- Systolic blood pressure (SBP) below 100 or above 140 mmHg (after 15 min of supine rest).
- Diastolic blood pressure (DBP) below 50 or above 90 mmHg (after 15 min of supine rest).
- Heart rate (HR) below 45 or above 90 bpm (after 15 min of supine rest).
- Clinically relevant findings in the physical examination.
- Positive results for HBsAg, anti-HCV, HIV antigen and antibody, and syphilis (cardiolipin-lecithin antigen, Treponema pallidum antibody).
- Creatine kinase (CK) above upper limit of normal (ULN), except marginal explainable changes which are expected to normalize before study intervention intake.
- Lipase and amylase above ULN (except isolated marginal increases of lipase or amylase to account for variability of the parameters, and the participant is asymptomatic and has no other laboratory changes assuming disease based on medical judgment).
- Glycosylated hemoglobin (HbA1c), serum creatinine, C-reactive protein (CRP), liver enzymes (e.g., alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, gamma-glutamyl transferase, total bilirubin) above ULN.
- Deviations from normal ranges of any other safety laboratory parameter indicating apparent disease (or for which disease cannot be excluded) or impacting the objectives of the study.
- Positive urine drug screening indicating drug abuse.
- Positive alcohol breath test.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single and Multiple Dose Escalation Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BAY 3283142 Given as Oral Tablets in Japanese Healthy Male 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).
The kidneys filter extra water and waste out of the blood and make urine. CKD is a long-term, progressive decrease in the kidneys' ability to work properly.
Read more
The study treatment BAY3283142 is under development for treating CKD. It works by activating a protein called soluble guanylate cyclase (sGC) that generates cGMP - a molecule that relaxes blood vessels and is thought to have beneficial effects in CKD.
The participants of this study will be healthy and will have no benefit from the intake of the study treatment. However, the study will provide information on how to use BAY3283142 in subsequent studies in people with CKD.
The main purpose of this study is to learn how safe the study treatment BAY3283142 is and how it affects the body in comparison to placebo when given as single and multiple amounts in healthy male participants in Japan. A placebo is a treatment that looks like a medicine but does not have any medicine in it.
To do this, the study team will compare the number of participants who have medical problems after taking BAY3283142 with those participants who take placebo. These medical problems are called adverse events. The study doctors and their team keep track of all medical problems that happen in studies, even if they do not think they might be related to the study treatments.
Another purpose of this study is to learn how the study treatment BAY3283142 moves into, through, and out of the body. To answer this, the study doctors and their team will take blood samples from the participants and measure:
- The average highest level of BAY3283142 in the blood (also called Cmax)
- The average total level of BAY3283142 in the blood (also called AUC).
Dependent on the treatment group, the participants will either take BAY3283142 or placebo as tablet once a day. A group of participants will start out by receiving a low amount of the study treatment. The study doctors will look at the results from these participants and then decide whether to increase the amount of the study treatment in the next group of participants. Researchers use dose escalation studies to learn about the safety of a specific amount before participants are given a higher amount.
Participants will be in the study for up to 7 weeks, including an in-house stay of up to 15 days. One test (screening) visit to the study center is planned before the start of treatment and one follow-up visit is planned after the end of treatment.
During the study, the study team will:
- check vital signs
- do physical examinations
- take blood and urine samples
- examine the participants' heart health using electrocardiogram (ECG)
- Conditions
- Chronic Kidney Disease, Healthy Volunteers
- Being tested
- BAY3283142, Placebo
- 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
Oral administration as tablet.
PlaceboOther
Oral administration as tablet.
| Study group | Role | What they receive |
|---|---|---|
| BAY3283142 (low dose) | Experimental | Participants will receive BAY3283142 as single low dose on Day 1 followed by multiple doses for 7 days from Day 3 to Day 9. Receives: Drug: BAY3283142 |
| BAY3283142 (medium dose) | Experimental | Participants will receive BAY3283142 as single medium dose on Day 1 followed by multiple doses for 7 days from Day 3 to Day 9 (optional arm). Receives: Drug: BAY3283142 |
| BAY3283142 (high dose) | Experimental | Participants will receive BAY3283142 as single high dose on Day 1 followed by multiple doses for 7 days from Day 3 to Day 9. Receives: Drug: BAY3283142 |
| Matching placebo | Placebo comparator | Participants will receive a BAY3283142 matching placebo as single dose on Day 1 followed by multiple doses for 7 days from Day 3 to Day 9. Receives: Other: 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 events (TEAEs)
Measured: Up to 7 days after end of treatment with study intervention, an average of 18 days
Secondary outcomes (4)
Area under the concentration versus time curve from zero to infinity (AUC) after single (first) dose of BAY3283142 on Day 1
Measured: 0 to 48 hours post-dose
Maximum observed drug concentration (Cmax) after single (first) dose administration of BAY3283142 on Day 1
Measured: 0 to 48 hours post-dose
AUC during any dose interval after (last) multiple doses of BAY3283142 on Day 9 (AUCτ,md)
An interval of 24 h will be used for τ (Tau).
Measured: 0 to 24 hours post-dose
Maximum observed drug concentration in measured matrix after (last) multiple doses of BAY3283142 on Day 9 (Cmax,md)
Measured: 0 to 24 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start3 Apr 2023
- Primary completion19 Jul 2023
- Study completion19 Jul 2023
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
- Basic science
- 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
- NCT05800444
- Sponsor's protocol ID
- 21938
- Status last verified
- Aug 2023
- First submitted
- 24 Mar 2023
- Last updated
- 21 Aug 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 21 Aug 2023. 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 Oral Tablets in Japanese Healthy Male Participants in a Randomized, Placebo-controlled, Single-blind, Group Comparison Design
- ClinicalTrials.gov ID
- NCT05800444
- Acronym / sponsor ID
- 21938
- Conditions
- Chronic Kidney Disease, Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 3 Apr 2023 (actual)
- Primary completion
- 19 Jul 2023 (actual)
- Study completion
- 19 Jul 2023 (actual)
- First posted
- 5 Apr 2023 (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).
The kidneys filter extra water and waste out of the blood and make urine. CKD is a long-term, progressive decrease in the kidneys' ability to work properly.
The study treatment BAY3283142 is under development for treating CKD. It works by activating a protein called soluble guanylate cyclase (sGC) that generates cGMP - a molecule that relaxes blood vessels and is thought to have beneficial effects in CKD.
The participants of this study will be healthy and will have no benefit from the intake of the study treatment. However, the study will provide information on how to use BAY3283142 in subsequent studies in people with CKD.
The main purpose of this study is to learn how safe the study treatment BAY3283142 is and how it affects the body in comparison to placebo when given as single and multiple amounts in healthy male participants in Japan. A placebo is a treatment that looks like a medicine but does not have any medicine in it.
To do this, the study team will compare the number of participants who have medical problems after taking BAY3283142 with those participants who take placebo. These medical problems are called adverse events. The study doctors and their team keep track of all medical problems that happen in studies, even if they do not think they might be related to the study treatments.
Another purpose of this study is to learn how the study treatment BAY3283142 moves into, through, and out of the body. To answer this, the study doctors and their team will take blood samples from the participants and measure:
- The average highest level of BAY3283142 in the blood (also called Cmax)
- The average total level of BAY3283142 in the blood (also called AUC).
Dependent on the treatment group, the participants will either take BAY3283142 or placebo as tablet once a day. A group of participants will start out by receiving a low amount of the study treatment. The study doctors will look at the results from these participants and then decide whether to increase the amount of the study treatment in the next group of participants. Researchers use dose escalation studies to learn about the safety of a specific amount before participants are given a higher amount.
Participants will be in the study for up to 7 weeks, including an in-house stay of up to 15 days. One test (screening) visit to the study center is planned before the start of treatment and one follow-up visit is planned after the end of treatment.
During the study, the study team will:
- check vital signs
- do physical examinations
- take blood and urine samples
- examine the participants' heart health using electrocardiogram (ECG)
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BAY3283142 (low dose) | Experimental | Drug: BAY3283142Participants will receive BAY3283142 as single low dose on Day 1 followed by multiple doses for 7 days from Day 3 to Day 9. |
| BAY3283142 (medium dose) | Experimental | Drug: BAY3283142Participants will receive BAY3283142 as single medium dose on Day 1 followed by multiple doses for 7 days from Day 3 to Day 9 (optional arm). |
| BAY3283142 (high dose) | Experimental | Drug: BAY3283142Participants will receive BAY3283142 as single high dose on Day 1 followed by multiple doses for 7 days from Day 3 to Day 9. |
| Matching placebo | Placebo comparator | Other: PlaceboParticipants will receive a BAY3283142 matching placebo as single dose on Day 1 followed by multiple doses for 7 days from Day 3 to Day 9. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Participant must be 20 to 50 years of age 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 tests, and 12 lead ECG.
- Race: Japanese.
- body mass index (BMI) within the range 18.0 and 29.9 kg/m^2 (inclusive).
- Body weight equal or above 55 kg (inclusive).
Key exclusion criteria (31 listed)
- Medical disorder, condition, or history of such that would impair the participant's ability to participate or complete this study in the opinion of the investigator.
- A history of clinically relevant diseases of any organs.
- Pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination, and effects of the study interventions will not be normal.
- Participants with thyroid disorders as evidenced by assessment of thyroid stimulating hormone levels outside the normal reference range.
- Known hypersensitivity to the study interventions (active substances or excipients of the preparations, e.g., lactose).
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 |
|---|---|---|
| BAY3283142Oral administration as tablet. | Drug | BAY3283142 (high dose), BAY3283142 (low dose), BAY3283142 (medium dose) |
| PlaceboOral administration as tablet. | Other | Matching placebo |
Primary outcome
Number of participants with treatment-emergent adverse events (TEAEs)
Time frame: Up to 7 days after end of treatment with study intervention, an average of 18 days
4 secondary outcomes
Area under the concentration versus time curve from zero to infinity (AUC) after single (first) dose of BAY3283142 on Day 1
Time frame: 0 to 48 hours post-dose
Maximum observed drug concentration (Cmax) after single (first) dose administration of BAY3283142 on Day 1
Time frame: 0 to 48 hours post-dose
AUC during any dose interval after (last) multiple doses of BAY3283142 on Day 9 (AUCτ,md)
Time frame: 0 to 24 hours post-dose
Maximum observed drug concentration in measured matrix after (last) multiple doses of BAY3283142 on Day 9 (Cmax,md)
Time frame: 0 to 24 hours post-dose
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 21 Aug 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 BAY3283142 in people with Chronic Kidney Disease 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 7 inclusion and 31 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 21 Aug 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. 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 events (TEAEs) (time frame: Up to 7 days after end of treatment with study intervention, an average of 18 days). 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 21 Aug 2023.