Adrenal InsufficiencyPhase 1NCT03343327
A Study of Chronocort® Versus Cortef ® in Healthy Adult Male Subjects
A Phase 1 study testing Chronocort® and Cortef® in people with Adrenal Insufficiency, run by Neurocrine UK Limited at 1 site in United Kingdom.
Trial summary
This was a single centre, open label, randomised, two period, crossover study to evaluate the bioavailability of Chronocort® versus Cortef® immediate release hydrocortisone tablets in dexamethasone-suppressed healthy adult male subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Adrenal Insufficiency
- What is being tested?
- Chronocort® and Cortef®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Feb 2018to 20 Apr 2018
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects between 18 and 45 years of age inclusive (at screening).
- A BMI of 18-30 kg/m2 (inclusive).
- No clinically significant abnormal serum biochemistry, haematology or urine examination values as defined by the Investigator.
- A negative urinary drugs of abuse screen. A positive alcohol test or drugs of abuse test may be repeated at the discretion of the Investigator.
- Negative HIV and Hepatitis Band C results.
- No clinically significant abnormalities in 12-lead ECG as defined by the Investigator.
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- No clinically significant deviation outside the normal ranges for blood pressure and heart rate measurements as defined by the Investigator.
- Subjects (unless anatomically sterile or where abstaining from sexual intercourse is in line with the preferred and usual lifestyle of the subject) and sexual partners must use 2 effective contraception methods during the trial and for 3 months after the last dose, for example:
- Oral, injected or implanted hormonal contraceptive+ condom
- Intra-uterine device (IUD) + condom
- Diaphragm with spermicide + condom
- Subjects must be available to complete both periods of the study and the follow-up visit.
- Subjects must satisfy a medical examiner about their fitness to participate in the study.
- Subjects must be able to read and understand the informed consent form and must provide written informed consent to participate in the study.
Who cannot join
- A clinically significant history of gastrointestinal disorder likely to influence drug absorption.
- Receipt of any medication with the exception of paracetamol within the 14 days prior to dosing (including topical steroids, vitamins, dietary supplements or herbal remedies).
- Evidence of renal. hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction.
- Receipt of any vaccination within the previous one month.
- Presence of infections (systemic fungal and viral infections, acute bacterial infections).
- Current or previous history of tuberculosis.
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- A clinically significant history of previous allergy/sensitivity to hydrocortisone and/or dexamethasone.
- Meeting any of the contraindications for Cortef® and/or dexamethasone, as detailed in the United States Prescribing Information (USPI)/Summary of Product Characteristics (SmPC), respectively
- A clinically significant history of drug or alcohol abuse.
- Inability to communicate well with the Investigator (i.e., language problem, poor mental development or impaired cerebral function).
- Participation in a New Chemical Entity clinical study or a marketed drug clinical study within the previous three months, or five half- lives of the study drug, whichever is the longer period. (NB. the three-month washout period between trials is defined as the period of time elapsed between the last dose of the previous study and the first dose of the next study).
- Subjects who have consumed more than two units of alcohol per day within seven days prior to the first dose or have consumed any alcohol within the 48-hour period prior to the first dose.
- Donation or receipt of 450 mL of blood within the previous three months.
- Subjects who smoke (or ex-smokers who have smoked within six months prior to first dose). This includes e-cigarette and shisha users.
- Subjects who work shifts (i.e. regularly alternate between days, afternoons and nights).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Centre, Open-label, Randomised, Single Dose, Two Period, Crossover Relative Bioavailability Study of Chronocort® Versus Cortef® Immediate Release Hydrocortisone Tablets in Dexamethasone-suppressed Healthy Adult Male Subjects.
This was a single centre, open label, randomised, two period, crossover study to evaluate the bioavailability of Chronocort® versus Cortef® immediate release hydrocortisone tablets in dexamethasone-suppressed healthy adult male subjects.
Read the detailed description
This study was an open-label, randomised, single dose, two-period, crossover study in 25 healthy male subjects.
The study comprised of a pre-study screen, followed by 2 treatment periods (1 and 2) and a post-study followup.
Screening (Day -28 to Day -1): Screening assessments were carried out within 28 days before first administration of IMP. Eligible subjects were asked to return for the treatment periods. Continued eligibility was confirmed pre-dose during each treatment period.
Treatment Periods (Day -1 to Day 1): Eligible subjects received a single-dose of each IMP over 2 treatment periods (1/period as determined by the randomisation schedule), each separated by 7 days washout. Each study period was approximately 2 days in duration, from the afternoon of Day -1 to the morning of Day 1 at 24 hours (h) post-dose. During each treatment period, Subjects arrived at the Clinical Unit on Day -1, IMP was administered on the morning of Day 0 fasted (following an overnight fast of at least 10 h) and subjects were discharged following the 24 h post-dose blood samples and completion of the scheduled measurements.
Pharmacokinetic (PK) samples were collected pre-dose at ~ -2min and up to 23 h post-dose (Day 1) (24 samples) for the measurement of cortisol. A further 3 baseline samples were taken for the measurement of cortisol. Safety was also evaluated throughout the study.
Post Study: After completion of both study periods, the subjects returned 4-22 days later for the final followup visit.
- Conditions
- Adrenal Insufficiency
- Being tested
- Chronocort®, Cortef®
- Medical subject headings
- Adrenal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chronocort®Drug
Single dose of 20mg Chronocort® administered in one treatment period
Cortef®Drug
Single dose of 20mg Cortef® administered in one treatment period
| Study group | Role | What they receive |
|---|---|---|
| Chronocort®, then Cortef® | Experimental | Single dose of 20mg Chronocort® (oral administration), followed by a single dose of 20mg Cortef® Immediate Release Hydrocortisone Tablets (oral administration). Receives: Drug: Chronocort®; Drug: Cortef® |
| Cortef®, then Chronocort® | Active comparator | Single dose of 20mg Cortef® Immediate Release Hydrocortisone Tablets (oral administration), followed by a single dose of 20mg Chronocort® (oral administration). Receives: Drug: Chronocort®; Drug: Cortef® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration time curve from time 0 to infinity (AUC0-inf) of Chronocort® to Cortef® based on baseline adjusted and unadjusted serum cortisol concentration calculated for each sampling time point.
Comparing the area under the concentration time curve of Chronocort® compared to Cortef® immediate release hydrocortisone tablets.
Measured: Samples taken at 0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 11,12, 13, 14, 16, 18, 20, 22, and 24 hours (morning of Day 1) in both periods.
Secondary outcomes (11)
Pharmacokinetic parameters for serum cortisol + relative bioavailability - Cmax
The following PK endpoint was derived from baseline adjusted and unadjusted serum cortisol concentration-time data following administration of each IMP.
◦ Cmax Maximum plasma cortisol concentration.
Measured: Samples taken at 0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 11,12, 13, 14, 16, 18, 20, 22, and 24 hours (morning of Day 1) in both periods.
Pharmacokinetic parameters for serum cortisol + relative bioavailability - Tmax
The following PK endpoint was derived from baseline adjusted and unadjusted serum cortisol concentration-time data following administration of each IMP.
◦ Tmax The time to maximum observed cortisol concentration sampled during a dosing interval.
Measured: Samples taken at 0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 11,12, 13, 14, 16, 18, 20, 22, and 24 hours (morning of Day 1) in both periods.
Pharmacokinetic parameters for serum cortisol + relative bioavailability - Kel
The following PK endpoint was derived from baseline adjusted and unadjusted serum cortisol concentration-time data following administration of each IMP.
◦ kel Elimination rate constant.
Measured: Samples taken at 0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 11,12, 13, 14, 16, 18, 20, 22, and 24 hours (morning of Day 1) in both periods.
Pharmacokinetic parameters for serum cortisol + relative bioavailability - t1/2
The following PK endpoint was derived from baseline adjusted and unadjusted serum cortisol concentration-time data following administration of each IMP.
◦ t1/2 Terminal half-life.
Measured: Samples taken at 0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 11,12, 13, 14, 16, 18, 20, 22, and 24 hours (morning of Day 1) in both periods.
Pharmacokinetic parameters for serum cortisol + relative bioavailability - AUC0-t
The following PK endpoint was derived from baseline adjusted and unadjusted serum cortisol concentration-time data following administration of each IMP.
◦ AUC0-t Area under the plasma cortisol concentration-time curve (AUC) from the time of dosing to the time of the last observed concentration.
Measured: Samples taken at 0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 11,12, 13, 14, 16, 18, 20, 22, and 24 hours (morning of Day 1) in both periods.
Pharmacokinetic parameters for serum cortisol - Serum cortisol clearance (CL/F)
Calculated as Dose / AUC0-inf. This PK endpoint was derived from baseline adjusted and unadjusted serum cortisol concentration-time data following administration of each IMP.
Measured: Samples taken at 0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 11,12, 13, 14, 16, 18, 20, 22, and 24 hours (morning of Day 1) in both periods.
Pharmacokinetic parameters for serum cortisol - Distribution during terminal elimination (Vz/F)
Volume of distribution based on the terminal elimination phase following extravascular administration derived from baseline adjusted and unadjusted serum cortisol
Measured: Samples taken at 0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 11,12, 13, 14, 16, 18, 20, 22, and 24 hours (morning of Day 1) in both periods.
Observed changes in Safety Laboratory Data
Observed changes in Safety Laboratory data (biochemistry, haematology \& urinalysis) during the course of the study, with any out of normal range values flagged.
Measured: Screening, Pre-dose and 10h and 24h post-dose during both treatment periods; Follow up
Observed changes in Vital Signs
Observed changes in vital signs data (blood pressure, pulse rate and oral temperature) during the course of the study, with any out of normal range values flagged.
Measured: Screening; Pre-dose and at 4 and 10h post-dose during both treatment periods; Follow up
Observed changes in Electrocardiogram (ECG) data during the course of the study
12-Lead ECG parameters (Heart Rate, PR interval, QRS width, QT interval, and QT interval corrected using Bazett's formula (QTcB)) and investigator clinical interpretation was listed with any out of normal range values flagged.
Measured: Screening, Pre-dose and 10h post-dose during both treatment periods; Follow up
Adverse Events
Adverse events (AEs) observed throughout the study
Measured: Through study completion - approximately 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start19 Feb 2018
- Primary completion20 Apr 2018
- Study completion20 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adrenal InsufficiencyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurocrine UK Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Simbec Research, Brush Clinical Research Ltd., Voet Consulting, Bionical Emas Ltd., Medical Matters International Ltd
- Responsible party
- Sponsor
- Investigators
- A Koch, Principal investigator, Simbec Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03343327
- Sponsor's protocol ID
- DIUR-008
- Status last verified
- Sep 2026
- First submitted
- 31 Oct 2017
- Last updated
- 14 Sep 2026
- 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 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Centre, Open-label, Randomised, Single Dose, Two Period, Crossover Relative Bioavailability Study of Chronocort® Versus Cortef® Immediate Release Hydrocortisone Tablets in Dexamethasone-suppressed Healthy Adult Male Subjects.
- ClinicalTrials.gov ID
- NCT03343327
- Acronym / sponsor ID
- DIUR-008
- Conditions
- Adrenal Insufficiency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Neurocrine UK LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Simbec Research, Brush Clinical Research Ltd., Voet Consulting, Bionical Emas Ltd., Medical Matters International Ltd
- Study start
- 19 Feb 2018 (actual)
- Primary completion
- 20 Apr 2018 (actual)
- Study completion
- 20 Apr 2018 (actual)
- First posted
- 17 Nov 2017 (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.
This was a single centre, open label, randomised, two period, crossover study to evaluate the bioavailability of Chronocort® versus Cortef® immediate release hydrocortisone tablets in dexamethasone-suppressed healthy adult male subjects.
Detailed description
This study was an open-label, randomised, single dose, two-period, crossover study in 25 healthy male subjects.
The study comprised of a pre-study screen, followed by 2 treatment periods (1 and 2) and a post-study followup.
Screening (Day -28 to Day -1): Screening assessments were carried out within 28 days before first administration of IMP. Eligible subjects were asked to return for the treatment periods. Continued eligibility was confirmed pre-dose during each treatment period.
Treatment Periods (Day -1 to Day 1): Eligible subjects received a single-dose of each IMP over 2 treatment periods (1/period as determined by the randomisation schedule), each separated by 7 days washout. Each study period was approximately 2 days in duration, from the afternoon of Day -1 to the morning of Day 1 at 24 hours (h) post-dose. During each treatment period, Subjects arrived at the Clinical Unit on Day -1, IMP was administered on the morning of Day 0 fasted (following an overnight fast of at least 10 h) and subjects were discharged following the 24 h post-dose blood samples and completion of the scheduled measurements.
Pharmacokinetic (PK) samples were collected pre-dose at ~ -2min and up to 23 h post-dose (Day 1) (24 samples) for the measurement of cortisol. A further 3 baseline samples were taken for the measurement of cortisol. Safety was also evaluated throughout the study.
Post Study: After completion of both study periods, the subjects returned 4-22 days later for the final followup visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronocort®, then Cortef® | Experimental | Drug: Chronocort®, Drug: Cortef®Single dose of 20mg Chronocort® (oral administration), followed by a single dose of 20mg Cortef® Immediate Release Hydrocortisone Tablets (oral administration). |
| Cortef®, then Chronocort® | Active comparator | Drug: Chronocort®, Drug: Cortef®Single dose of 20mg Cortef® Immediate Release Hydrocortisone Tablets (oral administration), followed by a single dose of 20mg Chronocort® (oral administration). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Healthy male subjects between 18 and 45 years of age inclusive (at screening).
- A BMI of 18-30 kg/m2 (inclusive).
- No clinically significant abnormal serum biochemistry, haematology or urine examination values as defined by the Investigator.
- A negative urinary drugs of abuse screen. A positive alcohol test or drugs of abuse test may be repeated at the discretion of the Investigator.
- Negative HIV and Hepatitis Band C results.
Key exclusion criteria (15 listed)
- A clinically significant history of gastrointestinal disorder likely to influence drug absorption.
- Receipt of any medication with the exception of paracetamol within the 14 days prior to dosing (including topical steroids, vitamins, dietary supplements or herbal remedies).
- Evidence of renal. hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction.
- Receipt of any vaccination within the previous one month.
- Presence of infections (systemic fungal and viral infections, acute bacterial infections).
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 |
|---|---|---|
| Chronocort®Single dose of 20mg Chronocort® administered in one treatment period | Drug | Chronocort®, then Cortef®, Cortef®, then Chronocort® |
| Cortef®Single dose of 20mg Cortef® administered in one treatment period | Drug | Chronocort®, then Cortef®, Cortef®, then Chronocort® |
Primary outcome
Area under the concentration time curve from time 0 to infinity (AUC0-inf) of Chronocort® to Cortef® based on baseline adjusted and unadjusted serum cortisol concentration calculated for each sampling time point.
Time frame: Samples taken at 0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 11,12, 13, 14, 16, 18, 20, 22, and 24 hours (morning of Day 1) in both periods.
Comparing the area under the concentration time curve of Chronocort® compared to Cortef® immediate release hydrocortisone tablets.
11 secondary outcomes
Pharmacokinetic parameters for serum cortisol + relative bioavailability - Cmax
Time frame: Samples taken at 0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 11,12, 13, 14, 16, 18, 20, 22, and 24 hours (morning of Day 1) in both periods.
Pharmacokinetic parameters for serum cortisol + relative bioavailability - Tmax
Time frame: Samples taken at 0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 11,12, 13, 14, 16, 18, 20, 22, and 24 hours (morning of Day 1) in both periods.
Pharmacokinetic parameters for serum cortisol + relative bioavailability - Kel
Time frame: Samples taken at 0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 11,12, 13, 14, 16, 18, 20, 22, and 24 hours (morning of Day 1) in both periods.
Pharmacokinetic parameters for serum cortisol + relative bioavailability - t1/2
Time frame: Samples taken at 0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 11,12, 13, 14, 16, 18, 20, 22, and 24 hours (morning of Day 1) in both periods.
Pharmacokinetic parameters for serum cortisol + relative bioavailability - AUC0-t
Time frame: Samples taken at 0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 11,12, 13, 14, 16, 18, 20, 22, and 24 hours (morning of Day 1) in both periods.
Pharmacokinetic parameters for serum cortisol - Serum cortisol clearance (CL/F)
Time frame: Samples taken at 0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 11,12, 13, 14, 16, 18, 20, 22, and 24 hours (morning of Day 1) in both periods.
Pharmacokinetic parameters for serum cortisol - Distribution during terminal elimination (Vz/F)
Time frame: Samples taken at 0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 11,12, 13, 14, 16, 18, 20, 22, and 24 hours (morning of Day 1) in both periods.
Observed changes in Safety Laboratory Data
Time frame: Screening, Pre-dose and 10h and 24h post-dose during both treatment periods; Follow up
Observed changes in Vital Signs
Time frame: Screening; Pre-dose and at 4 and 10h post-dose during both treatment periods; Follow up
Observed changes in Electrocardiogram (ECG) data during the course of the study
Time frame: Screening, Pre-dose and 10h post-dose during both treatment periods; Follow up
Adverse Events
Time frame: Through study completion - approximately 6 weeks
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 14 Sep 2026.
- 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.
A Koch principal investigator
Simbec Research
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 Chronocort® and Cortef® in people with Adrenal Insufficiency, run by Neurocrine UK Limited at 1 site in United Kingdom.
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 14 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 14 Sep 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 United Kingdom. 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?
Area under the concentration time curve from time 0 to infinity (AUC0-inf) of Chronocort® to Cortef® based on baseline adjusted and unadjusted serum cortisol concentration calculated for each sampling time point. (time frame: Samples taken at 0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 11,12, 13, 14, 16, 18, 20, 22, and 24 hours (morning of Day 1) in both periods.). 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 14 Sep 2026.