HealthyPhase 1NCT06408870

A Study in Healthy People to Compare How 2 Different Low Dose Formulations of BI 1015550 Are Taken up in the Body

A Phase 1 study testing BI 1015550 in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The main objective of this trial is to establish the bioequivalence of the BI 1015550 Formulation C2 (Test, T) and the BI 1015550 Formulation C1 (Reference, R) following a single oral dose administration. Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: BI 1015550
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 64 participants
Where: 1 siteGermany
Study dates: 6 Jun 2024to 28 Aug 2024
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy male or female subject according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
Age of 18 to 50 years (inclusive)
Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
Female subject who meets any of the following criteria for a highly effective contraception from at least 30 days before the first administration of trial medication until 7 days after last administration
Highly effective methods of contraception include:

Show all 15Show fewer

Use of oral hormonal contraception that prevents ovulation, plus condom
Use of combined (estrogen and progestogen-containing) hormonal contraception that prevents ovulation (intravaginal or transdermal)
Use of progestogen-only hormonal contraception that inhibits ovulation (only injectables or implants)
Use of intrauterine device (IUD) or intrauterine hormone-releasing system (IUS)
Sexually abstinent is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject.
Bilateral tubal occlusion
Women not of childbearing potential (WNOCBP) include:
Permanently surgically sterilised (including hysterectomy, bilateral oophorectomy and bilateral salpingectomy)
Postmenopausal, defined as no menses for 1 year without an alternative medical cause (in questionable cases a blood sample with levels of follicle stimulating hormone (FSH) above 40 U/L and estradiol below 30 ng/L is confirmatory) WNOCBP are not required to use any methods of contraception. For in vitro fertilization (IVF) and in foreign countries, female subjects should not participate in egg donation and male subjects should not participate in sperm donation from the first study drug administration, for the duration of the study and for at least 7 days after the last study drug administration.

Who cannot join

Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre(s) of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 beats per minute (bpm) at screening
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance, in particular, hepatic parameters (alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin) or renal parameters (creatinine) exceeding the upper limit of normal (ULN) at screening
Any evidence of a concomitant disease assessed as clinically relevant by the investigator
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders assessed as clinically relevant by the investigator
Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders including but not limited to depression and suicidal behaviour
History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply.

Trial locations and contacts

1 site in 1 country.

Germany1 site

CRS Clinical Research Services Mannheim GmbH
Mannheim, 68167

Other trials in Germany

About this study

Official title: Bioequivalence of the BI 1015550 Low Dose Formulation C2 and the BI 1015550 Low Dose Formulation C1 (Phase 3 Formulation) Following Oral Administration in Healthy Subjects (an Open-label, Randomised, Single-dose, Two-way Crossover Trial)

Conditions: Healthy
Being tested: BI 1015550

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BI 1015550Drug
Also called Nerandomilast
Participants received two formulations of nerandomilast separated by a washout period

Study groups in NCT06408870
Study group	Role	What they receive
BI 1015550 Formulation C1 (Reference, R) then BI 1015550 Formulation C2 (Test, T)	Experimental	For this two period crossover study arm, participants received treatment in the following order: Participants received a single oral dose of nerandomilast (BI 1015550), a low dose film coated tablet (formulation C1, titanium dioxide [TiO2]-containing phase III formulation, reference (R)) with 240 mL water after an overnight fast of at least 10 h (period 1). Participants received a single oral dose of nerandomilast (BI 10105550), a low dose film coated tablet (formulation C2, titanium dioxide [TiO2] free, test (T)) with 240 mL water after an overnight fast of at least 10 h (period 2). In between the treatment periods, participants went through a washout period of 10 days. Receives: Drug: BI 1015550
BI 1015550 Formulation C2 (Test, T) then BI 1015550 Formulation C1 (Reference, R)	Experimental	For this two period crossover study arm, participants received treatment in the following order: Participants received a single oral dose of nerandomilast (BI 10105550), a low dose film coated tablet (formulation C2, titanium dioxide [TiO2] free, test (T)) with 240 mL water after an overnight fast of at least 10 h (period 1). Participants received a single oral dose of nerandomilast (BI 1015550), a low dose film coated tablet (formulation C1, titanium dioxide [TiO2]-containing phase III formulation, reference (R)) with 240 mL water after an overnight fast of at least 10 h (period 2). In between the treatment periods, participants went through a washout period of 10 days. Receives: Drug: BI 1015550

What is being measured

The primary outcome is the main question the study is designed to answer.

Area Under the Concentration-time Curve of Nerandomilast in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
Area under the concentration-time curve of nerandomilast in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is presented.
The statistical model applied was an analysis of variance (ANOVA), with 'subjects within sequence' as a random effect and 'sequence,' 'period,' and 'treatment' as fixed effects.
Measured: Within 3 hours (hrs) prior to and at 15minutes (min), 30min, 45min, 1hrs, 1:15hrs, 1:30hrs, 1:45hrs, 2hrs, 2:30hrs, 3hrs, 3:30hrs, 4hrs, 6hrs, 8hrs, 12hrs, 24hrs, 34hrs, 48hrs, 58hrs, 72hrs, 96hrs, 120hrs, and 144hrs after nerandomilast intake.
Maximum Measured Concentration of Nerandomilast in Plasma (Cmax)
Maximum measured concentration of nerandomilast in plasma (Cmax) is presented. The statistical model applied was an analysis of variance (ANOVA), with 'subjects within sequence' as a random effect and 'sequence,' 'period,' and 'treatment' as fixed effects.
Measured: Within 3 hours (hrs) prior to and at 15minutes (min), 30min, 45min, 1hrs, 1:15hrs, 1:30hrs, 1:45hrs, 2hrs, 2:30hrs, 3hrs, 3:30hrs, 4hrs, 6hrs, 8hrs, 12hrs, 24hrs, 34hrs, 48hrs, 58hrs, 72hrs, 96hrs, 120hrs, and 144hrs after nerandomilast intake.

Secondary outcomes (1)

Area Under the Concentration-time Curve of Nerandomilast in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Area under the concentration-time curve of nerandomilast in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is presented.
The statistical model applied was an analysis of variance (ANOVA), with 'subjects within sequence' as a random effect and 'sequence,' 'period,' and 'treatment' as fixed effects.
Measured: Within 3 hours (hrs) prior to and at 15minutes (min), 30min, 45min, 1hrs, 1:15hrs, 1:30hrs, 1:45hrs, 2hrs, 2:30hrs, 3hrs, 3:30hrs, 4hrs, 6hrs, 8hrs, 12hrs, 24hrs, 34hrs, 48hrs, 58hrs, 72hrs, 96hrs, 120hrs, and 144hrs after nerandomilast intake.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Jun 202428 Aug 2024

First posted10 May 2024
Study start6 Jun 2024
Primary completion28 Aug 2024
Study completion28 Aug 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe 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: Treatment
Allocation: Randomised
Intervention model: Crossover
Model description: two-way crossover
Masking: None (open label)
Enrolment: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06408870
Sponsor's protocol ID: 1305-0051
Other IDs: 2023-509951-15-00, U1111-1301-0913, 2023
Status last verified: Jul 2025
First submitted: 7 May 2024
Last updated: 1 Dec 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Bioequivalence of the BI 1015550 Low Dose Formulation C2 and the BI 1015550 Low Dose Formulation C1 (Phase 3 Formulation) Following Oral Administration in Healthy Subjects (an Open-label, Randomised, Single-dose, Two-way Crossover Trial)
ClinicalTrials.gov ID: NCT06408870
Acronym / sponsor ID: 1305-0051
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 64 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 6 Jun 2024 (actual)
Primary completion: 28 Aug 2024 (actual)
Study completion: 28 Aug 2024 (actual)
First posted: 10 May 2024 (actual)
Results: Posted 1 Dec 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2
Model description: two-way crossover

Arm	Type	Receives
BI 1015550 Formulation C1 (Reference, R) then BI 1015550 Formulation C2 (Test, T)	Experimental	Drug: BI 1015550For this two period crossover study arm, participants received treatment in the following order: Participants received a single oral dose of nerandomilast (BI 1015550), a low dose film coated tablet (formulation C1, titanium dioxide [TiO2]-containing phase III formulation, reference (R)) with 240 mL water after an overnight fast of at least 10 h (period 1). Participants received a single oral dose of nerandomilast (BI 10105550), a low dose film coated tablet (formulation C2, titanium dioxide [TiO2] free, test (T)) with 240 mL water after an overnight fast of at least 10 h (period 2). In between the treatment periods, participants went through a washout period of 10 days.
BI 1015550 Formulation C2 (Test, T) then BI 1015550 Formulation C1 (Reference, R)	Experimental	Drug: BI 1015550For this two period crossover study arm, participants received treatment in the following order: Participants received a single oral dose of nerandomilast (BI 10105550), a low dose film coated tablet (formulation C2, titanium dioxide [TiO2] free, test (T)) with 240 mL water after an overnight fast of at least 10 h (period 1). Participants received a single oral dose of nerandomilast (BI 1015550), a low dose film coated tablet (formulation C1, titanium dioxide [TiO2]-containing phase III formulation, reference (R)) with 240 mL water after an overnight fast of at least 10 h (period 2). In between the treatment periods, participants went through a washout period of 10 days.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (15 listed)

Healthy male or female subject according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
Age of 18 to 50 years (inclusive)
Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
Female subject who meets any of the following criteria for a highly effective contraception from at least 30 days before the first administration of trial medication until 7 days after last administration

Key exclusion criteria (8 listed)

Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre(s) of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 beats per minute (bpm) at screening
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance, in particular, hepatic parameters (alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin) or renal parameters (creatinine) exceeding the upper limit of normal (ULN) at screening
Any evidence of a concomitant disease assessed as clinically relevant by the investigator
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders assessed as clinically relevant by the investigator

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
BI 1015550Also: NerandomilastParticipants received two formulations of nerandomilast separated by a washout period	Drug	BI 1015550 Formulation C1 (Reference, R) then BI 1015550 Formulation C2 (Test, T), BI 1015550 Formulation C2 (Test, T) then BI 1015550 Formulation C1 (Reference, R)

Primary outcome

Area Under the Concentration-time Curve of Nerandomilast in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
Time frame: Within 3 hours (hrs) prior to and at 15minutes (min), 30min, 45min, 1hrs, 1:15hrs, 1:30hrs, 1:45hrs, 2hrs, 2:30hrs, 3hrs, 3:30hrs, 4hrs, 6hrs, 8hrs, 12hrs, 24hrs, 34hrs, 48hrs, 58hrs, 72hrs, 96hrs, 120hrs, and 144hrs after nerandomilast intake.
Area under the concentration-time curve of nerandomilast in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is presented. The statistical model applied was an analysis of variance (ANOVA), with 'subjects within sequence' as a random effect and 'sequence,' 'period,' and 'treatment' as fixed effects.
Maximum Measured Concentration of Nerandomilast in Plasma (Cmax)
Time frame: Within 3 hours (hrs) prior to and at 15minutes (min), 30min, 45min, 1hrs, 1:15hrs, 1:30hrs, 1:45hrs, 2hrs, 2:30hrs, 3hrs, 3:30hrs, 4hrs, 6hrs, 8hrs, 12hrs, 24hrs, 34hrs, 48hrs, 58hrs, 72hrs, 96hrs, 120hrs, and 144hrs after nerandomilast intake.
Maximum measured concentration of nerandomilast in plasma (Cmax) is presented. The statistical model applied was an analysis of variance (ANOVA), with 'subjects within sequence' as a random effect and 'sequence,' 'period,' and 'treatment' as fixed effects.

1 secondary outcome

Area Under the Concentration-time Curve of Nerandomilast in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Time frame: Within 3 hours (hrs) prior to and at 15minutes (min), 30min, 45min, 1hrs, 1:15hrs, 1:30hrs, 1:45hrs, 2hrs, 2:30hrs, 3hrs, 3:30hrs, 4hrs, 6hrs, 8hrs, 12hrs, 24hrs, 34hrs, 48hrs, 58hrs, 72hrs, 96hrs, 120hrs, and 144hrs after nerandomilast intake.

Results and safety

Results posted to the registry on 1 Dec 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BI 1015550 Formulation C1 (Reference, R) then BI 1015550 Formulation C2 (Test, T)	32	32
BI 1015550 Formulation C2 (Test, T) then BI 1015550 Formulation C1 (Reference, R)	32	32

Primary outcome: Area Under the Concentration-time Curve of Nerandomilast in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)

Time frame: Within 3 hours (hrs) prior to and at 15minutes (min), 30min, 45min, 1hrs, 1:15hrs, 1:30hrs, 1:45hrs, 2hrs, 2:30hrs, 3hrs, 3:30hrs, 4hrs, 6hrs, 8hrs, 12hrs, 24hrs, 34hrs, 48hrs, 58hrs, 72hrs, 96hrs, 120hrs, and 144hrs after nerandomilast intake.. Geometric least squares mean (Standard Error). Unit: hours*nanomole/Liter (hrs*nmol/L)

Measure	BI 1015550 Formulation C1 (Reference, R) n = 64	BI 1015550 Formulation C2 (Test, T) n = 61
Value	1270.92 (na)	1320.24 (na)

BI 1015550 Formulation C1 (Reference, R) vs BI 1015550 Formulation C2 (Test, T): Ratio of adjusted geometric means [%]: 103.88 (90% CI 101.08 to 106.75)

Population analysed: Pharmacokinetic parameter analysis set (PKS): included all subjects in the treated set (TS) who provided at least one pharmacokinetic (PK) endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject was included in the PKS, even if he/she contributed only one PK parameter value for one period to the statistical assessment. Participants in both arms are not mutually exclusive.

Primary outcome: Maximum Measured Concentration of Nerandomilast in Plasma (Cmax)

Measure	BI 1015550 Formulation C1 (Reference, R) n = 64	BI 1015550 Formulation C2 (Test, T) n = 61
Value	218.84 (na)	230.48 (na)

BI 1015550 Formulation C1 (Reference, R) vs BI 1015550 Formulation C2 (Test, T): Ratio of adjusted geometric means [%]: 105.32 (90% CI 100.83 to 110.01)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: For all adverse events (AEs): From first nerandomilast intake until end of residual effect period (REP), up to 7 days. For all-cause mortality: From first nerandomilast intake until end of follow-up, up to 28 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BI 1015550 Formulation C1 (Reference, R)	0 of 64 (0%)	15 of 64 (23.4%)	0 of 64
BI 1015550 Formulation C2 (Test, T)	0 of 61 (0%)	10 of 61 (16.4%)	0 of 61

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: No. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency

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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 BI 1015550 in people with Healthy, run by Boehringer Ingelheim 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 15 inclusion and 8 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 1 Dec 2025. 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?

Yes. Results are posted in the registry (first posted 1 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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-time Curve of Nerandomilast in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) (time frame: Within 3 hours (hrs) prior to and at 15minutes (min), 30min, 45min, 1hrs, 1:15hrs, 1:30hrs, 1:45hrs, 2hrs, 2:30hrs, 3hrs, 3:30hrs, 4hrs, 6hrs, 8hrs, 12hrs, 24hrs, 34hrs, 48hrs, 58hrs, 72hrs, 96hrs, 120hrs, and 144hrs after nerandomilast intake.). 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?

On the ClinicalTrials.gov record for NCT06408870.

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 1 Dec 2025.