PharmacokineticsPhase 3NCT05277376
Pharmacokinetic (PK) Evaluation of Bemotrizinol (6%) in a Sunscreen Maximum Usage Trial
A Phase 3 study testing Bemotrizinol (6%) in people with Pharmacokinetics and Absorption; Chemicals, run by dsm-firmenich Switzerland AG at 1 site in United States.
Trial summary
An open-label, randomized, 3-arm study in 162 healthy adult subjects with the following primary objective: To assess the systemic absorption and pharmacokinetics of BEMT from 3 market image sunscreen formulations under maximal-use conditions. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics, Absorption; Chemicals
- What is being tested?
- Bemotrizinol (6%)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2022to 28 Oct 2022
- Phase
- Phase 3
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject signs an IRB-approved written informed consent form (ICF) and privacy language as per national regulations (e.g., Health Insurance Portability and Accountability Act [HIPAA] authorization) before any study-related procedures are performed.
- Subject is a healthy man or woman, ≥18 years of age and who has a body mass index of 18.5 to 29.9 kg/m2, inclusive, at Screening.
- Subject has normal medical history findings, clinical laboratory results, vital sign measurements, 12-lead electrocardiogram (ECG) results, and physical examination findings at Screening or, if abnormal, the abnormality is not considered clinically significant (as determined and documented by the investigator or designee).
- Subject has a negative test result for alcohol and drugs of abuse at Screening and Check-in (Day -1).
- Female subject is surgically sterile (hysterectomy, bilateral salpingo-oophorectomy, bilateral tubal ligation) or has a negative serum pregnancy test result before entry into the study and practices an adequate method of birth control (e.g., oral or parenteral contraceptives, hormonal or nonhormonal intrauterine device, barrier, abstinence) during the study and until 90 days after the last application of study drug.
- Male subject agrees to refrain from sexual activity with female partners unless an acceptable method of birth control is used by both partners. Male subject is surgically sterile or agrees to use barrier contraception (condom with spermicide), and refrain from sperm donation, from the first application of study drug until 90 days after the last application of study drug.
- Subject has a negative SARS-CoV-2 test result at Check-in (Day -1).
- Subject is highly likely (as determined by the investigator) to comply with the protocol-defined procedures and to complete the study.
Who cannot join
- Subject who participated in Part 1 of the present maximum usage trial (MUsT).
- Subject has broken, irritated, or unhealed skin.
- Subject has an active sunburn.
- Subject has used a tanning bed in the previous 4 weeks.
- Subject has known skin or autoimmune disease(s).
- Subject is anemic or has any chronic condition(s) that may impact blood sample collection.
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- Women who are pregnant, breastfeeding, or planning to become pregnant during the study or during the 30 days after study drug administration. All female subjects will undergo a serum pregnancy test at Screening, on Day -1, and before discharge from the CRU.
- Subject has any underlying disease or surgical or medical condition (e.g., cancer, HIV, severe hepatic or renal impairment) that could put the subject at risk or would normally prevent participation in a clinical study.
- Subject has known or suspected allergies or sensitivities to any components of the sunscreen formulation.
- Subject has clinical laboratory test results (hematology and serum chemistry) at Screening that are outside the reference ranges provided by the clinical laboratory and considered clinically significant by the investigator.
- Subject has used alcohol-, caffeine-, or xanthine-containing products, Seville oranges (sour), grapefruit, or grapefruit juice, within 72 hours before first study drug application.
- Subject has a positive test result at Screening for HIV type 1 or 2 antibody, hepatitis C virus antibodies, or hepatitis B surface antigen.
- Subject is unable or unwilling to undergo multiple venipunctures for blood sample collection because of poor tolerability or poor venous access.
- Subject has used any product(s) containing bis-ethylhexyloxyphenol methoxyphenyl triazine (BEMT), such as sunscreen products, hand or body moisturizing lotion, makeup or foundation, hair care product, lip balm, or lipstick within 14 days before Check-in (Day -1) and at any time before End-of-Study procedures.
- Subject is unable or unwilling to tolerate the scent of sunscreen and the body coverage with sunscreen (i.e., oily appearance and sensation of sunscreen) for the duration of the treatment period.
Trial locations and contacts
1 site in 1 country.
United States1 site
Spaulding Clinical Research LLC
West Bend, Wisconsin, 53095
About this study
Official title: Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT)
An open-label, randomized, 3-arm study in 162 healthy adult subjects with the following primary objective: To assess the systemic absorption and pharmacokinetics of BEMT from 3 market image sunscreen formulations under maximal-use conditions.
Read the detailed description
This study is an open-label, randomized, 3-arm pivotal study to evaluate the pharmacokinetics of BEMT after multiple applications of a topical sunscreen formulation in healthy adult subjects.162 subjects will be enrolled (54 subjects per study drug formulation arm) in order to achieve a minimum of 150 completers (50 completers in each arm).There will be an adequate representation of male and female subjects, subjects of all ages (including a sufficient number of elderly subjects), and subjects of different races.
All 162 subjects will randomized at Day -1 and assigned to a treatment arm before study drug application on Day 1.
Treatment: Approximately 2 mg of a sunscreen formulation (approximately 0.12 mg BEMT) per 1 cm2 of body surface area will be applied topically 4 times per study day for 4 days (every 2 hours for 6 hours) to at least 75% of the body surface area.
Subjects will be randomly assigned to 1 of 3 treatment groups within each subgroup; Thus each subject will receive 1 of the sunscreen formulations. Treatment groups:
Treatment Group B: 54 subjects; Treatment: BEMT, PARSOL Shield, 6%, with suitable solubilizers; SU-E-101413-85: Sunscreen oil formulation with 10% ethanol Treatment Group C: 54 subjects; Treatment: BEMT, PARSOL Shield, 6%, with suitable solubilizers, SU-E-101413-87: oil-in-water (O/W) formulation Treatment Croup D: 54 subjects: Treatment: BEMT, PARSOL Shield, 6%, with suitable solubilizers, SU-E-101413-89: water-in-oil (W/O) formulation
Dosing will between 07:00 and 10:00 hours followed by 3 more applications at 2, 4, and 6 hours after the 1st application each day. Blood samples collected from before the 1st application through 96 hours after the 1st application.
The following noncompartmental PK parameters will be calculated for each subject using the plasma BEMT concentration-time data (data permitting):
- Cmax: Maximum observed concentration; computed for Overall, Day 1, and Day 4
- Tmax: Time of Cmax; computed for Overall, Day 1, and Day 4
- C2h: The concentration at 2 hours after the 4th daily study drug application; computed for Days 1, 2, 3, and 4
- Ctrough: The concentration at the end of the study day; computed for Days 1, 2, 3, and 4 at 23.5, 47.5, 71.5, and 96 hours, respectively
- AUC: Area under the concentration-time curve from before the first daily dose to the last measurable concentration in the time interval; computed for Overall, Day 1, and Day 4
- λz: Apparent elimination rate constant, computed from all relevant concentration data following the last study drug application on Day 4
- t1/2: Terminal elimination half-life, computed from λz
With the time intervals for Overall and Days 1, 2, 3, and 4 defined as:
- Overall = 0 to 264 hours
- Day 1 = 0 to 23.5 hours
- Day 2 = 23.5 to 47.5 hours
- Day 3 = 47.5 to 71.5 hours
- Day 4 = 71.5 to 96 hours
Note: If all concentrations for a subject are below the limit of quantitation (BLQ), then only the C2h and Ctrough parameters will be reported for that subject.
.
- Conditions
- Pharmacokinetics, Absorption; Chemicals
- Being tested
- Bemotrizinol (6%)
- Keywords
- Sunscreen Maximum Usage Trial, MUsT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bemotrizinol (6%)Drug
Also called PARSOL SHIELD, BEMT, bis-ethylhexyloxyphenol methoxyphenyl triazine
Active sunscreen ingredient (Broad spectrum UV-Filter)
| Study group | Role | What they receive |
|---|---|---|
| BEMT Formulation SU-E-101413-85 | Active comparator | PK evaluation of 6% BEMT after multiple applications of a topical sunscreen formulation. Receives: Drug: Bemotrizinol (6%) |
| BEMT Formulation SU-E-101413-87 | Active comparator | PK evaluation of 6% BEMT after multiple applications of a topical sunscreen formulation. Receives: Drug: Bemotrizinol (6%) |
| BEMT Formulation SU-E-101413-89 | Active comparator | PK evaluation of 6% BEMT after multiple applications of a topical sunscreen formulation. Receives: Drug: Bemotrizinol (6%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Concentration (Cmax) of BEMT
Assess Cmax (maximum observed drug concentration) of BEMT in plasma from three high-penetrating sunscreen formulations under maximal-use conditions computed for Overall, Day 1, and Day 4. With the time intervals for Overall and Days 1, 2, 3, and 4 defined as: Overall = 0 to 264 hours; Day 1 = 0 to 23.5 hours; Day 2 = 23.5 to 47.5 hours; Day 3 = 47.5 to 71.5 hours; and Day 4 = 71.5 to 96 hours.
Measured: 4 days
Time of Maximum Observed Concentration (Tmax) of BEMT
Assess the time at which the maximum concentration (Cmax) of BEMT occurs in plasma from three high-penetrating sunscreen formulations under maximal-use conditions; Overall, Day 1, and Day 4. With the time intervals for Overall and Days 1, 2, 3, and 4 defined as: Overall = 0 to 264 hours; Day 1 = 0 to 23.5 hours; Day 2 = 23.5 to 47.5 hours; Day 3 = 47.5 to 71.5 hours; and Day 4 = 71.5 to 96 hours.
Measured: 4 days
Concentration of BEMT at 2 hours (C2h) after the 4th daily study drug application
Assess the plasma concentration of BEMT at 2 hours after the 4th daily study drug application; computed for Days 1, 2, 3, and 4
Measured: 4 days
Concentration at the end of the study day (Ctrough)
Assess plasma concentration of BEMT at the end of the study day, computed for Days 1, 2, 3, and 4 at 23.5, 47.5, 71.5, and 96 hours, respectively
Measured: 4 days
Area under the concentration-time curve (AUC)
Assess area under the concentration-time curve from before the first daily dose to the last measurable concentration in the time interval); computed for Overall, Day 1, and Day 4.
Measured: 4 days
Apparent elimination rate constant (λz)
Assess the apparent elimination rate constant for BEMT in plasma; computed from all relevant concentration data following the last study drug application on Day 4.
Measured: 4 days
Terminal elimination half-life (t1/2)
Assess the time required for BEMT to decrease by a factor of one-half in plasma computed from λz, which will be computed from all relevant concentration data following the last study drug application on Day 4.
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start15 Mar 2022
- Primary completion28 Oct 2022
- Study completion28 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies 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 3
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- This is an open-label, randomized, 3-arm study in 162 healthy adult subjects with the following objective: Primary: To assess the systemic absorption and pharmacokinetics of BEMT from 3 different market image sunscreen drug formulations containing 6% BEMT under maximal-use conditions.
- Masking
- None (open label)
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- dsm-firmenich Switzerland AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jennifer Boston, MSN, APNP, Principal investigator, Spaulding Clinical Research LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05277376
- Sponsor's protocol ID
- BEMT-001 (Part 2)
- Status last verified
- Mar 2022
- First submitted
- 11 Feb 2022
- Last updated
- 22 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultraviolet Filter Bemotrizinol (BEMT): Clinical Pharmacokinetics Evaluation in a Topical Maximum Usage Trial (MUsT)
- ClinicalTrials.gov ID
- NCT05277376
- Acronym / sponsor ID
- BEMT-001 (Part 2)
- Conditions
- Pharmacokinetics, Absorption; Chemicals
- Keywords
- Sunscreen Maximum Usage Trial, MUsT
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- dsm-firmenich Switzerland AGIndustry (pharma, biotech, devices)
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 28 Oct 2022 (actual)
- Study completion
- 28 Oct 2022 (actual)
- First posted
- 14 Mar 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.
An open-label, randomized, 3-arm study in 162 healthy adult subjects with the following primary objective: To assess the systemic absorption and pharmacokinetics of BEMT from 3 market image sunscreen formulations under maximal-use conditions.
Detailed description
This study is an open-label, randomized, 3-arm pivotal study to evaluate the pharmacokinetics of BEMT after multiple applications of a topical sunscreen formulation in healthy adult subjects.162 subjects will be enrolled (54 subjects per study drug formulation arm) in order to achieve a minimum of 150 completers (50 completers in each arm).There will be an adequate representation of male and female subjects, subjects of all ages (including a sufficient number of elderly subjects), and subjects of different races.
All 162 subjects will randomized at Day -1 and assigned to a treatment arm before study drug application on Day 1.
Treatment: Approximately 2 mg of a sunscreen formulation (approximately 0.12 mg BEMT) per 1 cm2 of body surface area will be applied topically 4 times per study day for 4 days (every 2 hours for 6 hours) to at least 75% of the body surface area.
Subjects will be randomly assigned to 1 of 3 treatment groups within each subgroup; Thus each subject will receive 1 of the sunscreen formulations. Treatment groups:
Treatment Group B: 54 subjects; Treatment: BEMT, PARSOL Shield, 6%, with suitable solubilizers; SU-E-101413-85: Sunscreen oil formulation with 10% ethanol Treatment Group C: 54 subjects; Treatment: BEMT, PARSOL Shield, 6%, with suitable solubilizers, SU-E-101413-87: oil-in-water (O/W) formulation Treatment Croup D: 54 subjects: Treatment: BEMT, PARSOL Shield, 6%, with suitable solubilizers, SU-E-101413-89: water-in-oil (W/O) formulation
Dosing will between 07:00 and 10:00 hours followed by 3 more applications at 2, 4, and 6 hours after the 1st application each day. Blood samples collected from before the 1st application through 96 hours after the 1st application.
The following noncompartmental PK parameters will be calculated for each subject using the plasma BEMT concentration-time data (data permitting):
- Cmax: Maximum observed concentration; computed for Overall, Day 1, and Day 4
- Tmax: Time of Cmax; computed for Overall, Day 1, and Day 4
- C2h: The concentration at 2 hours after the 4th daily study drug application; computed for Days 1, 2, 3, and 4
- Ctrough: The concentration at the end of the study day; computed for Days 1, 2, 3, and 4 at 23.5, 47.5, 71.5, and 96 hours, respectively
- AUC: Area under the concentration-time curve from before the first daily dose to the last measurable concentration in the time interval; computed for Overall, Day 1, and Day 4
- λz: Apparent elimination rate constant, computed from all relevant concentration data following the last study drug application on Day 4
- t1/2: Terminal elimination half-life, computed from λz
With the time intervals for Overall and Days 1, 2, 3, and 4 defined as:
- Overall = 0 to 264 hours
- Day 1 = 0 to 23.5 hours
- Day 2 = 23.5 to 47.5 hours
- Day 3 = 47.5 to 71.5 hours
- Day 4 = 71.5 to 96 hours
Note: If all concentrations for a subject are below the limit of quantitation (BLQ), then only the C2h and Ctrough parameters will be reported for that subject.
.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is an open-label, randomized, 3-arm study in 162 healthy adult subjects with the following objective: Primary: To assess the systemic absorption and pharmacokinetics of BEMT from 3 different market image sunscreen drug formulations containing 6% BEMT under maximal-use conditions.
| Arm | Type | Receives |
|---|---|---|
| BEMT Formulation SU-E-101413-85 | Active comparator | Drug: Bemotrizinol (6%)PK evaluation of 6% BEMT after multiple applications of a topical sunscreen formulation. |
| BEMT Formulation SU-E-101413-87 | Active comparator | Drug: Bemotrizinol (6%)PK evaluation of 6% BEMT after multiple applications of a topical sunscreen formulation. |
| BEMT Formulation SU-E-101413-89 | Active comparator | Drug: Bemotrizinol (6%)PK evaluation of 6% BEMT after multiple applications of a topical sunscreen formulation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject signs an IRB-approved written informed consent form (ICF) and privacy language as per national regulations (e.g., Health Insurance Portability and Accountability Act [HIPAA] authorization) before any study-related procedures are performed.
- Subject is a healthy man or woman, ≥18 years of age and who has a body mass index of 18.5 to 29.9 kg/m2, inclusive, at Screening.
- Subject has normal medical history findings, clinical laboratory results, vital sign measurements, 12-lead electrocardiogram (ECG) results, and physical examination findings at Screening or, if abnormal, the abnormality is not considered clinically significant (as determined and documented by the investigator or designee).
- Subject has a negative test result for alcohol and drugs of abuse at Screening and Check-in (Day -1).
- Female subject is surgically sterile (hysterectomy, bilateral salpingo-oophorectomy, bilateral tubal ligation) or has a negative serum pregnancy test result before entry into the study and practices an adequate method of birth control (e.g., oral or parenteral contraceptives, hormonal or nonhormonal intrauterine device, barrier, abstinence) during the study and until 90 days after the last application of study drug.
Key exclusion criteria (15 listed)
- Subject who participated in Part 1 of the present maximum usage trial (MUsT).
- Subject has broken, irritated, or unhealed skin.
- Subject has an active sunburn.
- Subject has used a tanning bed in the previous 4 weeks.
- Subject has known skin or autoimmune disease(s).
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 |
|---|---|---|
| Bemotrizinol (6%)Also: PARSOL SHIELD, BEMT, bis-ethylhexyloxyphenol methoxyphenyl triazineActive sunscreen ingredient (Broad spectrum UV-Filter) | Drug | BEMT Formulation SU-E-101413-85, BEMT Formulation SU-E-101413-87, BEMT Formulation SU-E-101413-89 |
Primary outcome
Maximum Observed Concentration (Cmax) of BEMT
Time frame: 4 days
Assess Cmax (maximum observed drug concentration) of BEMT in plasma from three high-penetrating sunscreen formulations under maximal-use conditions computed for Overall, Day 1, and Day 4. With the time intervals for Overall and Days 1, 2, 3, and 4 defined as: Overall = 0 to 264 hours; Day 1 = 0 to 23.5 hours; Day 2 = 23.5 to 47.5 hours; Day 3 = 47.5 to 71.5 hours; and Day 4 = 71.5 to 96 hours.
Time of Maximum Observed Concentration (Tmax) of BEMT
Time frame: 4 days
Assess the time at which the maximum concentration (Cmax) of BEMT occurs in plasma from three high-penetrating sunscreen formulations under maximal-use conditions; Overall, Day 1, and Day 4. With the time intervals for Overall and Days 1, 2, 3, and 4 defined as: Overall = 0 to 264 hours; Day 1 = 0 to 23.5 hours; Day 2 = 23.5 to 47.5 hours; Day 3 = 47.5 to 71.5 hours; and Day 4 = 71.5 to 96 hours.
Concentration of BEMT at 2 hours (C2h) after the 4th daily study drug application
Time frame: 4 days
Assess the plasma concentration of BEMT at 2 hours after the 4th daily study drug application; computed for Days 1, 2, 3, and 4
Concentration at the end of the study day (Ctrough)
Time frame: 4 days
Assess plasma concentration of BEMT at the end of the study day, computed for Days 1, 2, 3, and 4 at 23.5, 47.5, 71.5, and 96 hours, respectively
Area under the concentration-time curve (AUC)
Time frame: 4 days
Assess area under the concentration-time curve from before the first daily dose to the last measurable concentration in the time interval); computed for Overall, Day 1, and Day 4.
Apparent elimination rate constant (λz)
Time frame: 4 days
Assess the apparent elimination rate constant for BEMT in plasma; computed from all relevant concentration data following the last study drug application on Day 4.
Terminal elimination half-life (t1/2)
Time frame: 4 days
Assess the time required for BEMT to decrease by a factor of one-half in plasma computed from λz, which will be computed from all relevant concentration data following the last study drug application on Day 4.
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 22 Feb 2023.
- Individual participant dataSharing planned: No
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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.
Jennifer Boston, MSN, APNP principal investigator
Spaulding Clinical Research LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bemotrizinol (6%) in people with Pharmacokinetics and Absorption; Chemicals, run by dsm-firmenich Switzerland AG at 1 site in United States.
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 8 inclusion and 15 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 22 Feb 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 United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Concentration (Cmax) of BEMT (time frame: 4 days). The study lists 7 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 22 Feb 2023.