A Phase 1 interventional study of Chronocort® and Cortef® in Adrenal Insufficiency, sponsored by Neurocrine UK Limited. Completed at 1 site in United Kingdom. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by Neurocrine UK Limited (formerly part of Neurocrine Biosciences) · Phase 1, Interventional, and Treatment
Among 23 studies testing hydrocortisone in Adrenal Insufficiency — 2 open to participants now, 2 under way, none of them phase 3. Hydrocortisone · Adrenal Insufficiency.
Among the 23 studies testing hydrocortisone in Adrenal Insufficiency, this one is the 17th largest by enrollment, is one of 2 that started in 2018, is one of 6 in phase 1, and was the 19th registered.
136 studies on the registry are indexed under Adrenal Insufficiency; 27 are open to participants now.
Browse Adrenal Insufficiency studies →2 of the 23 studies testing hydrocortisone in Adrenal Insufficiency are open now, in 1 country. Recruiting first, the newest first:
Marianne Christina Klose · Sites in Denmark
Marianne Andersen · Sites in Denmark
By country, each count listing its studies:
Hydrocortisone: first FDA approval 1951 (HYDROCORTONE), first EMA approval 2011. What it is approved for, and how studies give it, is on its page →
Of the 20 Adrenal Insufficiency studies recruiting now, 7 (35%) set no upper age limit and 7 (35%) stop at 75 or younger; 5 take children under 18; 5 take healthy volunteers.
This study: 18 Years to 45 Years · male · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
23 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 6 · Phase 2 4 · Phase 3 6 · Phase 4 8
First in 2002; this study’s year is marked. 2 started in 2018.
This study's enrollment of 25 is below the median of 44 across 71 interventional studies indexed under Adrenal Insufficiency.
Median enrollment 50 across the 23 interventional studies. Of the 17 that completed or were terminated, 7 (41%) have results posted.
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9 of 23 have an industry lead sponsor. The 10 most frequent:
Neurocrine UK Limited is the lead sponsor of 18 studies on the registry; none are open to participants now.
Neurocrine UK Limited has 9 studies filed under Adrenal Insufficiency — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 23 studies testing hydrocortisone in Adrenal Insufficiency, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 methods during the trial and for 3 months after the last dose, for example:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single dose of 20mg Chronocort® (oral administration), followed by a single dose of 20mg Cortef® Immediate Release Hydrocortisone Tablets (oral administration).
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).
Drug: Chronocort® · Drug: Cortef®
Single dose of 20mg Chronocort® administered in one treatment period
Single dose of 20mg Cortef® administered in one treatment period
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.
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 - 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.
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
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.
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
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.
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
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.
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
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.
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)
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.
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)
Volume of distribution based on the terminal elimination phase following extravascular administration derived from baseline adjusted and unadjusted serum cortisol
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
Observed changes in Safety Laboratory data (biochemistry, haematology \& urinalysis) during the course of the study, with any out of normal range values flagged.
Time frame: 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.
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
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.
Time frame: Screening, Pre-dose and 10h post-dose during both treatment periods; Follow up
Adverse Events
Adverse events (AEs) observed throughout the study
Time frame: Through study completion - approximately 6 weeks
Plan to share: No
No publications or documents are linked to this record.
Ran from Feb 2018 to primary completion in Apr 2018, 2 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Hydrocortisone