HealthyPhase 1NCT05392530
A Study of Two Different Test Formulations Compared to the Reference Formulation of Macitentan in Healthy Adult Participants
A Phase 1 study testing Macitentan in people with Healthy, run by Actelion at 1 site in Belgium.
Trial summary
The purpose of this study is to assess the rate and extent of absorption of a single oral dose of macitentan given as 2 test formulations compared to the reference formulation under fed conditions in healthy adult participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Macitentan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteBelgium
- Study dates
- 25 May 2022to 14 Sep 2022
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy on the basis of physical examination and medical and surgical history, performed at screening. If there are abnormalities, the participant may be included only if the investigator judges the abnormalities to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the investigator
- Systolic blood pressure (SBP) between 100 and 145 millimeters of mercury (mmHg) (inclusive), diastolic blood pressure (DBP) between 50 and 90 mmHg (inclusive), and pulse rate between 45 and 90 beats per minute (inclusive), within 3 minutes after standing up and after the participant is supine for at least 5 minutes, at screening
- Twelve-lead electrocardiogram (ECG) without clinically relevant abnormalities, at the discretion of the investigator, measured after the participant is supine for at least 5 minutes, at screening
- Body weight not less than 50 kilograms (Kg) and body mass index (BMI; weight/height^2) within the range 18.5 -30 kg per meter square (kg/m^2) (inclusive)at screening
- All women must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) pregnancy test at screening and a negative urine pregnancy test on Day -1 of the first treatment period
Who cannot join
- Known allergies, hypersensitivity, or intolerance to any active substance or drugs of the same class, or any excipient of the drug formulation(s)
- History or clinical evidence of any disease and/or existence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism, or excretion of the study intervention(s) (appendectomy and herniotomy allowed, cholecystectomy not allowed)
- A history of repeated fainting due to cardiac cause, collapse, syncope, orthostatic hypotension, or vasovagal reactions
- Female participant who is breastfeeding at screening and plans to breastfeed throughout the study
- Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Open-label, Single-dose, Randomized, 3-way Crossover Phase 1 Study in Healthy Adult Participants to Assess the Relative Oral Bioavailability of Macitentan 75 mg as Two Different Test Formulations Compared to the Reference Formulation
The purpose of this study is to assess the rate and extent of absorption of a single oral dose of macitentan given as 2 test formulations compared to the reference formulation under fed conditions in healthy adult participants.
- Conditions
- Healthy
- Being tested
- Macitentan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MacitentanDrug
Also called Opsumit
Macitentan film coated tablets will be administered orally as per assigned treatment sequence.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Sequence ABC | Experimental | Participants will receive single oral dose of final marketing image (FMI) candidate #1 of macitentan (Treatment A [test]) under fed condition in Treatment Period 1, followed by single oral dose of FMI candidate #2 of macitentan (Treatment B [test]) under fed conditions in Treatment Period 2, and then single oral dose of the reference formulation of macitentan (Treatment C) under fed conditions in Treatment Period 3. The study intervention administrations will be separated by at least 14 days to allow adequate washout duration following the single doses. Receives: Drug: Macitentan |
| Treatment Sequence BCA | Experimental | Participants will receive Treatment B in Treatment Period 1 followed by Treatment C in Treatment Period 2, and then Treatment A in Treatment Period 3 on Day 1. The study intervention administrations will be separated by at least 14 days to allow adequate washout duration following the single doses. Receives: Drug: Macitentan |
| Treatment Sequence CAB | Experimental | Participants will receive Treatment C in Treatment Period 1 followed by Treatment A in Treatment Period 2, and then Treatment B in Treatment Period 3 on Day 1. The study intervention administrations will be separated by at least 14 days to allow adequate washout duration following the single doses. Receives: Drug: Macitentan |
| Treatment Sequence ACB | Experimental | Participants will receive Treatment A in Treatment Period 1 followed by Treatment C in Treatment Period 2, and then Treatment B in Treatment Period 3 on Day 1. The study intervention administrations will be separated by at least 14 days to allow adequate washout duration following the single doses. Receives: Drug: Macitentan |
| Treatment Sequence CBA | Experimental | Participants will receive Treatment C in Treatment Period 1 followed by Treatment B in Treatment Period 2, and then Treatment A in Treatment Period 3 on Day 1. The study intervention administrations will be separated by at least 14 days to allow adequate washout duration following the single doses. Receives: Drug: Macitentan |
| Treatment Sequence BAC | Experimental | Participants will receive Treatment B in Treatment Period 1 followed by Treatment A in treatment period 2, and then Treatment C in Treatment Period 3 on Day 1. The study intervention administrations will be separated by at least 14 days to allow adequate washout duration following the single doses. Receives: Drug: Macitentan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Analyte Concentration (Cmax) of Macitentan
Cmax is defined as maximum observed plasma analyte concentration of macitentan.
Measured: Predose, up to 336 hours post dose (up to Day 15)
Area Under the Plasma Analyte Concentration-time Curve from Time Zero to Time of the Last Quantifiable Concentration of Macitentan (AUC[0-last])
AUC(0-last) is defined as area under the plasma analyte concentration-time curve of macitentan from time zero to time of the last quantifiable (non-below quantification limit [BQL]) concentration.
Measured: Predose, up to 336 hours post dose (up to Day 15)
Area Under the Plasma Analyte Concentration-time Curve from Time Zero to Infinite Time (AUC[0-infinity]) of Macitentan
AUC(0-infinity) is defined as area under the plasma analyte concentration-time curve of macitentan from time zero to infinite time.
Measured: Predose, up to 336 hours post dose (up to Day 15)
Secondary outcomes (16)
Actual Sampling Time to Reach the Maximum Observed Plasma Analyte Concentration (Tmax) of Macitentan and its Metabolite Aprocitentan
Tmax is defined as actual sampling time to reach the maximum observed plasma analyte concentration of macitentan and its metabolite aprocitentan.
Measured: Predose, up to 336 hours post dose (up to Day 15)
Last Observed Measurable Plasma Analyte Concentration (Clast) of Macitentan and its Metabolite Aprocitentan
Clast is defined as last observed measurable plasma analyte concentration of macitentan and its metabolite aprocitentan.
Measured: Predose, up to 336 hours post dose (up to Day 15)
Area Under the Plasma Analyte Concentration-time Curve of Macitentan and its Metabolite Aprocitentan from Time Zero to 72 Hours Post dose (AUC[0-72 Hours])
AUC(0-72 hours) is defined as area under the plasma analyte concentration-time curve of macitentan and its metabolite aprocitentan from time zero to 72 hours post dose, calculated by linear-linear trapezoidal summation.
Measured: Predose, up to 336 hours post dose (up to Day 15)
Apparent Terminal Elimination Half-life (t1/2) of Macitentan and its Metabolite Aprocitentan
t1/2 is defined as apparent terminal elimination half-life of macitentan and its metabolite aprocitentan.
Measured: Predose, up to 336 hours post dose (up to Day 15)
Apparent Terminal Elimination Rate Constant (Lambda[z]) of Macitentan and its Metabolite Aprocitentan
Lambda(z) is defined as apparent terminal elimination rate constant of macitentan and its metabolite aprocitentan, estimated by linear regression using the terminal log-linear phase of the log transformed concentration versus time curve.
Measured: Predose, up to 336 hours post dose (up to Day 15)
Total Apparent Oral Clearance (CL/F) of Macitentan
CL/F of macitentan is defined as total apparent oral clearance, calculated as dose/AUC (0-infinity).
Measured: Predose, up to 336 hours post dose (up to Day 15)
Apparent Volume of Distribution (Vdz/F) of Macitentan
Vdz/F of macitentan is defined as apparent volume of distribution, calculated as dose/(Lambda[z]*AUC [0-infinity]).
Measured: Predose, up to 336 hours post dose (up to Day 15)
Maximum Observed Plasma Analyte Concentration (Cmax) of Aprocitentan
Cmax is defined as maximum observed plasma analyte concentration of metabolite aprocitentan.
Measured: Predose, up to 336 hours post dose (up to Day 15)
Area Under the Plasma Analyte Concentration-Time Curve from Time Zero to Time of the Last Quantifiable Concentration of Aprocitentan (AUC[0-last])
AUC(0-last) of metabolite Aprocitentan is defined as area under the plasma analyte concentration-time curve from time zero to time of the last quantifiable (BQL) concentration, calculated by linear-linear trapezoidal summation.
Measured: Predose, up to 336 hours post dose (up to Day 15)
Area Under the Plasma Analyte Concentration-Time Curve of Aprocitentan from Time Zero to Infinity (AUC[0-infinity])
AUC(0-infinity) is defined as area under the plasma analyte concentration-time curve of metabolite aprocitentan from time zero to infinite time.
Measured: Predose, up to 336 hours post dose (up to Day 15)
Number of Participants with Serious Adverse Events (SAEs)
Number of Participants with Serious Adverse Events (SAEs) will be reported SAE is any untoward medical occurrence that at any dose may results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.
Measured: Up to 13 weeks
Number of Participants with Adverse Events (AEs)
Number of participants with AEs will be reported. An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product.
Measured: Up to 13 weeks
Number of Participants with Abnormalities in Physical Examination
Number of participants with abnormalities in physical examination (including general appearance, respiratory, neurological, eyes, ear/nose/throat, thyroid, cardiovascular, abdominal/gastrointestinal, hepatic, musculoskeletal, and dermatologic) will be reported.
Measured: Up to Day 15
Number of Participants with Abnormalities in Vital Signs
Number of participants with abnormalities in vital signs (including temperature [tympanic], pulse rate, and blood pressure) will be reported.
Measured: Up to Day 15
Number of Participants with Abnormalities in Electrocardiograms (ECGs)
Number of participants with abnormalities in ECGs will be reported.
Measured: Up to Day 15
Number of Participants with Abnormalities in Clinical Laboratory Tests
Number of participants with abnormalities in clinical laboratory tests (including serum chemistry, hematology, and urinalysis) will be reported.
Measured: Up to Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start25 May 2022
- Primary completion30 Aug 2022
- Study completion14 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Actelion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Actelion Clinical Trial, Study director, Actelion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05392530
- Sponsor's protocol ID
- CR109202
- Other IDs
- 2022-000275-39, 67896062PAH1012
- Status last verified
- Mar 2025
- First submitted
- 23 May 2022
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Open-label, Single-dose, Randomized, 3-way Crossover Phase 1 Study in Healthy Adult Participants to Assess the Relative Oral Bioavailability of Macitentan 75 mg as Two Different Test Formulations Compared to the Reference Formulation
- ClinicalTrials.gov ID
- NCT05392530
- Acronym / sponsor ID
- CR109202
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- ActelionIndustry (pharma, biotech, devices)
- Study start
- 25 May 2022 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 14 Sep 2022 (actual)
- First posted
- 26 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the rate and extent of absorption of a single oral dose of macitentan given as 2 test formulations compared to the reference formulation under fed conditions in healthy adult participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Treatment Sequence ABC | Experimental | Drug: MacitentanParticipants will receive single oral dose of final marketing image (FMI) candidate #1 of macitentan (Treatment A [test]) under fed condition in Treatment Period 1, followed by single oral dose of FMI candidate #2 of macitentan (Treatment B [test]) under fed conditions in Treatment Period 2, and then single oral dose of the reference formulation of macitentan (Treatment C) under fed conditions in Treatment Period 3. The study intervention administrations will be separated by at least 14 days to allow adequate washout duration following the single doses. |
| Treatment Sequence BCA | Experimental | Drug: MacitentanParticipants will receive Treatment B in Treatment Period 1 followed by Treatment C in Treatment Period 2, and then Treatment A in Treatment Period 3 on Day 1. The study intervention administrations will be separated by at least 14 days to allow adequate washout duration following the single doses. |
| Treatment Sequence CAB | Experimental | Drug: MacitentanParticipants will receive Treatment C in Treatment Period 1 followed by Treatment A in Treatment Period 2, and then Treatment B in Treatment Period 3 on Day 1. The study intervention administrations will be separated by at least 14 days to allow adequate washout duration following the single doses. |
| Treatment Sequence ACB | Experimental | Drug: MacitentanParticipants will receive Treatment A in Treatment Period 1 followed by Treatment C in Treatment Period 2, and then Treatment B in Treatment Period 3 on Day 1. The study intervention administrations will be separated by at least 14 days to allow adequate washout duration following the single doses. |
| Treatment Sequence CBA | Experimental | Drug: MacitentanParticipants will receive Treatment C in Treatment Period 1 followed by Treatment B in Treatment Period 2, and then Treatment A in Treatment Period 3 on Day 1. The study intervention administrations will be separated by at least 14 days to allow adequate washout duration following the single doses. |
| Treatment Sequence BAC | Experimental | Drug: MacitentanParticipants will receive Treatment B in Treatment Period 1 followed by Treatment A in treatment period 2, and then Treatment C in Treatment Period 3 on Day 1. The study intervention administrations will be separated by at least 14 days to allow adequate washout duration following the single doses. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy on the basis of physical examination and medical and surgical history, performed at screening. If there are abnormalities, the participant may be included only if the investigator judges the abnormalities to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the investigator
- Systolic blood pressure (SBP) between 100 and 145 millimeters of mercury (mmHg) (inclusive), diastolic blood pressure (DBP) between 50 and 90 mmHg (inclusive), and pulse rate between 45 and 90 beats per minute (inclusive), within 3 minutes after standing up and after the participant is supine for at least 5 minutes, at screening
- Twelve-lead electrocardiogram (ECG) without clinically relevant abnormalities, at the discretion of the investigator, measured after the participant is supine for at least 5 minutes, at screening
- Body weight not less than 50 kilograms (Kg) and body mass index (BMI; weight/height^2) within the range 18.5 -30 kg per meter square (kg/m^2) (inclusive)at screening
- All women must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) pregnancy test at screening and a negative urine pregnancy test on Day -1 of the first treatment period
Key exclusion criteria (5 listed)
- Known allergies, hypersensitivity, or intolerance to any active substance or drugs of the same class, or any excipient of the drug formulation(s)
- History or clinical evidence of any disease and/or existence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism, or excretion of the study intervention(s) (appendectomy and herniotomy allowed, cholecystectomy not allowed)
- A history of repeated fainting due to cardiac cause, collapse, syncope, orthostatic hypotension, or vasovagal reactions
- Female participant who is breastfeeding at screening and plans to breastfeed throughout the study
- Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
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 |
|---|---|---|
| MacitentanAlso: OpsumitMacitentan film coated tablets will be administered orally as per assigned treatment sequence. | Drug | Treatment Sequence ABC, Treatment Sequence ACB, Treatment Sequence BAC, Treatment Sequence BCA, Treatment Sequence CAB, Treatment Sequence CBA |
Primary outcome
Maximum Observed Plasma Analyte Concentration (Cmax) of Macitentan
Time frame: Predose, up to 336 hours post dose (up to Day 15)
Cmax is defined as maximum observed plasma analyte concentration of macitentan.
Area Under the Plasma Analyte Concentration-time Curve from Time Zero to Time of the Last Quantifiable Concentration of Macitentan (AUC[0-last])
Time frame: Predose, up to 336 hours post dose (up to Day 15)
AUC(0-last) is defined as area under the plasma analyte concentration-time curve of macitentan from time zero to time of the last quantifiable (non-below quantification limit [BQL]) concentration.
Area Under the Plasma Analyte Concentration-time Curve from Time Zero to Infinite Time (AUC[0-infinity]) of Macitentan
Time frame: Predose, up to 336 hours post dose (up to Day 15)
AUC(0-infinity) is defined as area under the plasma analyte concentration-time curve of macitentan from time zero to infinite time.
16 secondary outcomes
Actual Sampling Time to Reach the Maximum Observed Plasma Analyte Concentration (Tmax) of Macitentan and its Metabolite Aprocitentan
Time frame: Predose, up to 336 hours post dose (up to Day 15)
Last Observed Measurable Plasma Analyte Concentration (Clast) of Macitentan and its Metabolite Aprocitentan
Time frame: Predose, up to 336 hours post dose (up to Day 15)
Area Under the Plasma Analyte Concentration-time Curve of Macitentan and its Metabolite Aprocitentan from Time Zero to 72 Hours Post dose (AUC[0-72 Hours])
Time frame: Predose, up to 336 hours post dose (up to Day 15)
Apparent Terminal Elimination Half-life (t1/2) of Macitentan and its Metabolite Aprocitentan
Time frame: Predose, up to 336 hours post dose (up to Day 15)
Apparent Terminal Elimination Rate Constant (Lambda[z]) of Macitentan and its Metabolite Aprocitentan
Time frame: Predose, up to 336 hours post dose (up to Day 15)
Total Apparent Oral Clearance (CL/F) of Macitentan
Time frame: Predose, up to 336 hours post dose (up to Day 15)
Apparent Volume of Distribution (Vdz/F) of Macitentan
Time frame: Predose, up to 336 hours post dose (up to Day 15)
Maximum Observed Plasma Analyte Concentration (Cmax) of Aprocitentan
Time frame: Predose, up to 336 hours post dose (up to Day 15)
Area Under the Plasma Analyte Concentration-Time Curve from Time Zero to Time of the Last Quantifiable Concentration of Aprocitentan (AUC[0-last])
Time frame: Predose, up to 336 hours post dose (up to Day 15)
Area Under the Plasma Analyte Concentration-Time Curve of Aprocitentan from Time Zero to Infinity (AUC[0-infinity])
Time frame: Predose, up to 336 hours post dose (up to Day 15)
Number of Participants with Serious Adverse Events (SAEs)
Time frame: Up to 13 weeks
Number of Participants with Adverse Events (AEs)
Time frame: Up to 13 weeks
Number of Participants with Abnormalities in Physical Examination
Time frame: Up to Day 15
Number of Participants with Abnormalities in Vital Signs
Time frame: Up to Day 15
Number of Participants with Abnormalities in Electrocardiograms (ECGs)
Time frame: Up to Day 15
Number of Participants with Abnormalities in Clinical Laboratory Tests
Time frame: Up to Day 15
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 30 Mar 2025.
- Individual participant dataSharing planned: Yes. The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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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.
Actelion Clinical Trial study director
Actelion
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 Macitentan in people with Healthy, run by Actelion at 1 site in Belgium.
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 30 Mar 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 Belgium. 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?
Maximum Observed Plasma Analyte Concentration (Cmax) of Macitentan (time frame: Predose, up to 336 hours post dose (up to Day 15)). The study lists 3 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 30 Mar 2025.