Chronic Kidney DiseasePhase 1NCT07722585
A Study to Learn About How a New Nurandociguat Tablet is Absorbed and Processed in the Body Compared to an Old Tablet and How Food Affects the Way the New Tablet is Absorbed and Processed in the Body
A Phase 1 study testing Nurandociguat (BAY3283142) old tablet - SD, Nurandociguat (BAY3283142) new tablet - SD and Nurandociguat (BAY3283142) old tablet in people with Chronic Kidney Disease, run by Bayer at 1 site in Germany.
Trial summary
Researchers conduct this clinical study to learn more about a new tablet of a medicine called nurandociguat. Nurandociguat is being developed as a possible treatment for people with chronic kidney disease (CKD) which is a long-term condition in which the ability of the kidneys to properly function decreases over time. Read more about this study
- Who is it for?
- Ages 18 to 58 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Nurandociguat (BAY3283142) old tablet - SD, Nurandociguat (BAY3283142) new tablet - SD and Nurandociguat (BAY3283142) old tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteGermany
- Study dates
- 28 Jul 2026to 12 Oct 2026
- 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 58 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant must be 18 to 58 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, vital signs (blood pressure and heart rate), electrocardiogram (ECG), body temperature, and laboratory tests.
- Body Mass Index (BMI) within the range 18.0 and 29.9 kg/m^2 (inclusive).
- Body weight above or equal 60 kg.
- Male and female.
Who cannot join
- 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.
- Acute diarrhea or constipation within 14 days before the first intake of study intervention.
- Regular use of medicines within the last 14 days before the first study intervention administration.
- Special diets preventing the participants from eating the standard meals during the study.
- Participant is unable or unwilling to comply with study restrictions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Center, Open-label Study Assessing the Relative Bioavailability of a New Nurandociguat Tablet Formulation Versus an Existing Formulation and Investigating the Food Effect of the New Tablet Formulation
Researchers conduct this clinical study to learn more about a new tablet of a medicine called nurandociguat. Nurandociguat is being developed as a possible treatment for people with chronic kidney disease (CKD) which is a long-term condition in which the ability of the kidneys to properly function decreases over time. It is often caused by high blood glucose levels.
The main purposes of the study are
Read more
- To learn how the new nurandociguat tablet is absorbed and processed in the body (which is also known as "pharmacokinetics [PK]" measurement) compared to an old tablet when taken without food.
- To learn how food affects the way the new tablet is absorbed and processed in the body when taken with a high-fat, high-calorie meal (like a big breakfast).
To do this, researchers will take blood samples from the participants and measure:
- Maximum observed concentration (Cmax): the highest concentration of nurandociguat in participants' plasma
- Area under the concentration time curve (AUC): the total amount of nurandociguat in participants' plasma over time Another purpose of this study is to learn how safe the new nurandociguat tablet is. Therefore researchers will monitor the number of participants who experience medical problems during this study. These medical problems are called adverse events.
Only healthy participants are taking part in this study. During the study, participants will receive 2 different types of nurandociguat tablets. These include the newly developed tablet and an existing tablet that has already been used in previous clinical studies. Each participant will receive 3 different treatments:
- Treatment A: Nurandociguat old tablet, taken without food
- Treatment B: Nurandociguat new tablet, taken without food
- Treatment C: Nurandociguat new tablet, taken with food Researchers have proposed 5 optional dosing schemes for this clinical study, however only one scheme will be selected based on the findings from an ongoing clinical study. Afterwards, the study will start.
- For Optional Scheme 1-3, each participant will receive the three treatments A, B, and C, one at a time, in a different order for each participant with a break of at least 7 days between treatments.
- The Optional Schemes 4-5 follow a fixed sequence design. Each participant will first receive the nurandociguat new tablet formulation at a lower dose for 7 days, then receive the higher dose for in total 11 days. The higher dose will be administered for 5 days using the old tablet formulation followed by 6 days using the new tablet formulation. PK measurement will be assessed after 5 days of treatment with the old tablet formulation (without food), after 5 days of treatment with the new tablet formulation (without food) and after 6 days of treatment with the new tablet formulation (with food).
The researchers will closely monitor and manage any medical problems that the participants may have during the study.
- Conditions
- Chronic Kidney Disease
- Being tested
- Nurandociguat (BAY3283142) old tablet - SD, Nurandociguat (BAY3283142) new tablet - SD, Nurandociguat (BAY3283142) old tablet, Nurandociguat (BAY3283142) new tablet
- 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.
Nurandociguat (BAY3283142) old tablet - SDDrug
Single dose (SD) in treatment A.
Nurandociguat (BAY3283142) new tablet - SDDrug
Single dose (SD) in treatment B and C.
Nurandociguat (BAY3283142) old tabletDrug
High dose once daily for 5 days.
Nurandociguat (BAY3283142) new tabletDrug
Low dose once daily for 7 days, high dose once daily for 6 days.
| Study group | Role | What they receive |
|---|---|---|
| Optional Scheme 1-3: Treatment A-B-C | Experimental | Treatment A: Single dose of nurandociguat old tablet taken without food. Treatment B: Single dose of nurandociguat new tablet taken without food. Treatment C: Single dose of nurandociguat new tablet taken with food. Wash-out between treatments will be at least 7 days after last study drug administration. Receives: Drug: Nurandociguat (BAY3283142) old tablet - SD; Drug: Nurandociguat (BAY3283142) new tablet - SD |
| Optional Scheme 1-3: Treatment A-C-B | Experimental | Treatment A: Single dose of nurandociguat old tablet taken without food. Treatment C: Single dose of nurandociguat new tablet taken with food. Treatment B: Single dose of nurandociguat new tablet taken without food. Wash-out between treatments will be at least 7 days after last study drug administration. Receives: Drug: Nurandociguat (BAY3283142) old tablet - SD; Drug: Nurandociguat (BAY3283142) new tablet - SD |
| Optional Scheme 1-3: Treatment B-A-C | Experimental | Treatment B: Single dose of nurandociguat new tablet taken without food. Treatment A: Single dose of nurandociguat old tablet taken without food. Treatment C: Single dose of nurandociguat new tablet taken with food. Wash-out between treatments will be at least 7 days after last study drug administration. Receives: Drug: Nurandociguat (BAY3283142) old tablet - SD; Drug: Nurandociguat (BAY3283142) new tablet - SD |
| Optional Scheme 1-3: Treatment B-C-A | Experimental | Treatment B: Single dose of nurandociguat new tablet taken without food. Treatment C: Single dose of nurandociguat new tablet taken with food. Treatment A: Single dose of nurandociguat old tablet taken without food. Wash-out between treatments will be at least 7 days after last study drug administration. Receives: Drug: Nurandociguat (BAY3283142) old tablet - SD; Drug: Nurandociguat (BAY3283142) new tablet - SD |
| Optional Scheme 1-3: Treatment C-A-B | Experimental | Treatment C: Single dose of nurandociguat new tablet taken with food. Treatment A: Single dose of nurandociguat old tablet taken without food. Treatment B: Single dose of nurandociguat new tablet taken without food. Wash-out between treatments will be at least 7 days after last study drug administration. Receives: Drug: Nurandociguat (BAY3283142) old tablet - SD; Drug: Nurandociguat (BAY3283142) new tablet - SD |
| Optional Scheme 1-3: Treatment C-B-A | Experimental | Treatment C: Single dose of nurandociguat new tablet taken with food. Treatment B: Single dose of nurandociguat new tablet taken without food. Treatment A: Single dose of nurandociguat old tablet taken without food. Wash-out between treatments will be at least 7 days after last study drug administration. Receives: Drug: Nurandociguat (BAY3283142) old tablet - SD; Drug: Nurandociguat (BAY3283142) new tablet - SD |
| Optional Scheme 4-5 | Experimental | Participants will receive nurandociguat new tablet for 7 days at a lower starting dose. Afterwards, there will be up titration to a higher dose for 11 days (nurandociguat old tablet for 5 days followed by PK analysis of old tablet formulation without food at steady state after 5 days; nurandociguat new tablet for 6 days followed by PK analysis of new tablet formulation without food at steady state after 5 days and with food after 6 days). Receives: Drug: Nurandociguat (BAY3283142) old tablet; Drug: Nurandociguat (BAY3283142) new tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optional scheme 1-3 - Cmax for nurandociguat
Cmax=Maximum observed concentration
Measured: 0-72 hours post dose
Optional scheme 1-3 - AUC for nurandociguat
AUC=Area under the concentration time curve
Measured: 0-72 hours post dose
Optional scheme 4 and 5 - Cmax,md for nurandociguat
Cmax,md=Cmax after multiple dosing
Measured: 0-24 hours post dose
Optional scheme 4 and 5 - AUCt,md for nurandociguat
AUCt,md=AUC after multiple dosing. t (Tau)=24 hours.
Measured: 0-24 hours post dose
Secondary outcomes (1)
Number of participants with treatment-emergent adverse events (TEAEs)
Measured: From the first dose of study intervention up to 7 days after end of treatment with study intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start28 Jul 2026
- Primary completion12 Oct 2026
- Study completion12 Oct 2026
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
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07722585
- Sponsor's protocol ID
- 22700
- Other IDs
- 2025-524176-36-00, 2025
- Status last verified
- 16 Oct 2026
- First submitted
- 17 Jul 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Currently, there is no established plan for the sharing of Individual Patient Data (IPD) from this study. The 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 the scope, timepoint, and process of data access. As such, Bayer commits to considering requests from qualified researchers for patient- / study-level clinical trial data, and documents from clinical trials involving medicines and indications approved in the US and EU. However, this commitment does not reflect an active IPD sharing plan. 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. Researchers can use www.vivli.org to request access to IPD and documents from clinical studies to conduct research. Information on Bayer's criteria for listing studies is provided in the member section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Open-label Study Assessing the Relative Bioavailability of a New Nurandociguat Tablet Formulation Versus an Existing Formulation and Investigating the Food Effect of the New Tablet Formulation
- ClinicalTrials.gov ID
- NCT07722585
- Acronym / sponsor ID
- 22700
- Conditions
- Chronic Kidney Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 28 Jul 2026 (actual)
- Primary completion
- 12 Oct 2026 (actual)
- Study completion
- 12 Oct 2026 (actual)
- First posted
- 23 Jul 2026 (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 conduct this clinical study to learn more about a new tablet of a medicine called nurandociguat. Nurandociguat is being developed as a possible treatment for people with chronic kidney disease (CKD) which is a long-term condition in which the ability of the kidneys to properly function decreases over time. It is often caused by high blood glucose levels.
The main purposes of the study are
- To learn how the new nurandociguat tablet is absorbed and processed in the body (which is also known as "pharmacokinetics [PK]" measurement) compared to an old tablet when taken without food.
- To learn how food affects the way the new tablet is absorbed and processed in the body when taken with a high-fat, high-calorie meal (like a big breakfast).
To do this, researchers will take blood samples from the participants and measure:
- Maximum observed concentration (Cmax): the highest concentration of nurandociguat in participants' plasma
- Area under the concentration time curve (AUC): the total amount of nurandociguat in participants' plasma over time Another purpose of this study is to learn how safe the new nurandociguat tablet is. Therefore researchers will monitor the number of participants who experience medical problems during this study. These medical problems are called adverse events.
Only healthy participants are taking part in this study. During the study, participants will receive 2 different types of nurandociguat tablets. These include the newly developed tablet and an existing tablet that has already been used in previous clinical studies. Each participant will receive 3 different treatments:
- Treatment A: Nurandociguat old tablet, taken without food
- Treatment B: Nurandociguat new tablet, taken without food
- Treatment C: Nurandociguat new tablet, taken with food Researchers have proposed 5 optional dosing schemes for this clinical study, however only one scheme will be selected based on the findings from an ongoing clinical study. Afterwards, the study will start.
- For Optional Scheme 1-3, each participant will receive the three treatments A, B, and C, one at a time, in a different order for each participant with a break of at least 7 days between treatments.
- The Optional Schemes 4-5 follow a fixed sequence design. Each participant will first receive the nurandociguat new tablet formulation at a lower dose for 7 days, then receive the higher dose for in total 11 days. The higher dose will be administered for 5 days using the old tablet formulation followed by 6 days using the new tablet formulation. PK measurement will be assessed after 5 days of treatment with the old tablet formulation (without food), after 5 days of treatment with the new tablet formulation (without food) and after 6 days of treatment with the new tablet formulation (with food).
The researchers will closely monitor and manage any medical problems that the participants may have during the study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Optional Scheme 1-3: Treatment A-B-C | Experimental | Drug: Nurandociguat (BAY3283142) old tablet - SD, Drug: Nurandociguat (BAY3283142) new tablet - SDTreatment A: Single dose of nurandociguat old tablet taken without food. Treatment B: Single dose of nurandociguat new tablet taken without food. Treatment C: Single dose of nurandociguat new tablet taken with food. Wash-out between treatments will be at least 7 days after last study drug administration. |
| Optional Scheme 1-3: Treatment A-C-B | Experimental | Drug: Nurandociguat (BAY3283142) old tablet - SD, Drug: Nurandociguat (BAY3283142) new tablet - SDTreatment A: Single dose of nurandociguat old tablet taken without food. Treatment C: Single dose of nurandociguat new tablet taken with food. Treatment B: Single dose of nurandociguat new tablet taken without food. Wash-out between treatments will be at least 7 days after last study drug administration. |
| Optional Scheme 1-3: Treatment B-A-C | Experimental | Drug: Nurandociguat (BAY3283142) old tablet - SD, Drug: Nurandociguat (BAY3283142) new tablet - SDTreatment B: Single dose of nurandociguat new tablet taken without food. Treatment A: Single dose of nurandociguat old tablet taken without food. Treatment C: Single dose of nurandociguat new tablet taken with food. Wash-out between treatments will be at least 7 days after last study drug administration. |
| Optional Scheme 1-3: Treatment B-C-A | Experimental | Drug: Nurandociguat (BAY3283142) old tablet - SD, Drug: Nurandociguat (BAY3283142) new tablet - SDTreatment B: Single dose of nurandociguat new tablet taken without food. Treatment C: Single dose of nurandociguat new tablet taken with food. Treatment A: Single dose of nurandociguat old tablet taken without food. Wash-out between treatments will be at least 7 days after last study drug administration. |
| Optional Scheme 1-3: Treatment C-A-B | Experimental | Drug: Nurandociguat (BAY3283142) old tablet - SD, Drug: Nurandociguat (BAY3283142) new tablet - SDTreatment C: Single dose of nurandociguat new tablet taken with food. Treatment A: Single dose of nurandociguat old tablet taken without food. Treatment B: Single dose of nurandociguat new tablet taken without food. Wash-out between treatments will be at least 7 days after last study drug administration. |
| Optional Scheme 1-3: Treatment C-B-A | Experimental | Drug: Nurandociguat (BAY3283142) old tablet - SD, Drug: Nurandociguat (BAY3283142) new tablet - SDTreatment C: Single dose of nurandociguat new tablet taken with food. Treatment B: Single dose of nurandociguat new tablet taken without food. Treatment A: Single dose of nurandociguat old tablet taken without food. Wash-out between treatments will be at least 7 days after last study drug administration. |
| Optional Scheme 4-5 | Experimental | Drug: Nurandociguat (BAY3283142) old tablet, Drug: Nurandociguat (BAY3283142) new tabletParticipants will receive nurandociguat new tablet for 7 days at a lower starting dose. Afterwards, there will be up titration to a higher dose for 11 days (nurandociguat old tablet for 5 days followed by PK analysis of old tablet formulation without food at steady state after 5 days; nurandociguat new tablet for 6 days followed by PK analysis of new tablet formulation without food at steady state after 5 days and with food after 6 days). |
Who may qualify
- Ages
- 18 to 58 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Participant must be 18 to 58 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, vital signs (blood pressure and heart rate), electrocardiogram (ECG), body temperature, and laboratory tests.
- Body Mass Index (BMI) within the range 18.0 and 29.9 kg/m^2 (inclusive).
- Body weight above or equal 60 kg.
- Male and female.
Key exclusion criteria (5 listed)
- 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.
- Acute diarrhea or constipation within 14 days before the first intake of study intervention.
- Regular use of medicines within the last 14 days before the first study intervention administration.
- Special diets preventing the participants from eating the standard meals during the study.
- Participant is unable or unwilling to comply with study restrictions.
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 |
|---|---|---|
| Nurandociguat (BAY3283142) old tablet - SDSingle dose (SD) in treatment A. | Drug | Optional Scheme 1-3: Treatment A-B-C, Optional Scheme 1-3: Treatment A-C-B, Optional Scheme 1-3: Treatment B-A-C, Optional Scheme 1-3: Treatment B-C-A, Optional Scheme 1-3: Treatment C-A-B, Optional Scheme 1-3: Treatment C-B-A |
| Nurandociguat (BAY3283142) new tablet - SDSingle dose (SD) in treatment B and C. | Drug | Optional Scheme 1-3: Treatment A-B-C, Optional Scheme 1-3: Treatment A-C-B, Optional Scheme 1-3: Treatment B-A-C, Optional Scheme 1-3: Treatment B-C-A, Optional Scheme 1-3: Treatment C-A-B, Optional Scheme 1-3: Treatment C-B-A |
| Nurandociguat (BAY3283142) old tabletHigh dose once daily for 5 days. | Drug | Optional Scheme 4-5 |
| Nurandociguat (BAY3283142) new tabletLow dose once daily for 7 days, high dose once daily for 6 days. | Drug | Optional Scheme 4-5 |
Primary outcome
Optional scheme 1-3 - Cmax for nurandociguat
Time frame: 0-72 hours post dose
Cmax=Maximum observed concentration
Optional scheme 1-3 - AUC for nurandociguat
Time frame: 0-72 hours post dose
AUC=Area under the concentration time curve
Optional scheme 4 and 5 - Cmax,md for nurandociguat
Time frame: 0-24 hours post dose
Cmax,md=Cmax after multiple dosing
Optional scheme 4 and 5 - AUCt,md for nurandociguat
Time frame: 0-24 hours post dose
AUCt,md=AUC after multiple dosing. t (Tau)=24 hours.
1 secondary outcome
Number of participants with treatment-emergent adverse events (TEAEs)
Time frame: From the first dose of study intervention up to 7 days after end of treatment with study intervention
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 19 Oct 2026.
- Individual participant dataSharing planned: No. Currently, there is no established plan for the sharing of Individual Patient Data (IPD) from this study. The 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 the scope, timepoint, and process of data access. As such, Bayer commits to considering requests from qualified researchers for patient- / study-level clinical trial data, and documents from clinical trials involving medicines and indications approved in the US and EU. However, this commitment does not reflect an active IPD sharing plan. 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. Researchers can use www.vivli.org to request access to IPD and documents from clinical studies to conduct research. Information on Bayer's criteria for listing studies 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 Nurandociguat (BAY3283142) old tablet - SD, Nurandociguat (BAY3283142) new tablet - SD and Nurandociguat (BAY3283142) old tablet in people with Chronic Kidney Disease, run by Bayer at 1 site in Germany.
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 5 inclusion and 5 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 19 Oct 2026. 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 Germany. 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?
Optional scheme 1-3 - Cmax for nurandociguat (time frame: 0-72 hours post dose). 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 Oct 2026.