A Phase 1 interventional study of Hydrocortisone and Chronocort in Congenital Adrenal Hyperplasia and Adrenal Insufficiency, sponsored by Neurocrine UK Limited. Completed. Open to male participants aged 18 Years to 60 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 17 studies testing hydrocortisone in Adrenal Hyperplasia, Congenital — 1 open to participants now, 1 under way, none of them phase 3. Hydrocortisone · Adrenal Hyperplasia, Congenital.
Among the 17 studies testing hydrocortisone in Adrenal Hyperplasia, Congenital, this one is the 8th largest by enrollment, is the only one that started in 2010, is one of 3 in phase 1, and was the 10th registered.
101 studies on the registry are indexed under Adrenal Hyperplasia, Congenital; 28 are open to participants now.
Browse Adrenal Hyperplasia, Congenital studies →1 of the 17 studies testing hydrocortisone in Adrenal Hyperplasia, Congenital is open now, in 1 country. Recruiting first, the newest first:
Federico II University · Sites in Italy
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 Hyperplasia, Congenital studies recruiting now, 10 (50%) set no upper age limit and 9 (45%) stop at 75 or younger; 7 take children under 18; 0 take healthy volunteers.
This study: 18 Years to 60 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.
17 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 5 · Phase 2 5 · Phase 3 6 · Phase 4 2
First in 1995; this study’s year is marked. 1 started in 2010.
This study's enrollment of 30 is below the median of 37 across 50 interventional studies indexed under Adrenal Hyperplasia, Congenital.
Median enrollment 28 across the 17 interventional studies. Of the 13 that completed or were terminated, 8 (62%) have results posted.
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9 of 17 have an industry lead sponsor. The 9 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 8 studies filed under Adrenal Hyperplasia, Congenital — fewer than ten, so there is no comparison to draw.
1 of the studies testing hydrocortisone in Adrenal Hyperplasia, Congenital that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03760835Federico II UniversityCongenital Adrenal Hyperplasia Once Daily Hydrocortisone Treatment | 2026-12-31 |
Among the 17 studies testing hydrocortisone in Adrenal Hyperplasia, Congenital, from their registry updates:
Nothing recorded among them since 2026-09-25.
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This was an open label, randomized, single dose, three period crossover pharmacokinetic study of Chronocort® in 30 healthy male volunteers. The study was conducted in smaller sub groups (Group 1, n=18 and Group 2, n=12).
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 and sexual partners must have used 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.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
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.
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.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
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.
Volunteers in group 1 received the following interventions: Chronocort® 30 mg given at night (\~ 23:00h) as a combination of one 10mg capsule and one 20mg capsule (n=18). Chronocort® 30mg given as one 20mg capsule at night (\~ 23:00h) and as one 10mg capsule in the morning (\~ 7:00h) following the initial night-time dose (n=18). Hydrocortisone 30mg given at night (\~ 23:00h) given as three 10mg tablets (n=18). Each administration of IMP was separated by a washout period of at least 7 days.
Drug: Hydrocortisone · Drug: Chronocort
Volunteers in group 2 received the following interventions: Chronocort® 5mg given at night (\~ 23:00h) as one 5mg capsule (n=12). Chronocort® 10mg given at night (\~ 23:00h) as one 10mg capsule (n=12). Chronocort® 20mg given at night (\~ 23:00h) as one 20mg capsule (n=12). Each administration of IMP was separated by a washout period of at least 7 days.
Drug: Chronocort
Generic hydrocortisone
Modified formulation of hydrocortisone
Derived pharmacokinetic parameter: Tmax
Tmax measures the time at which Cmax - maximum serum concentration - is observed
Time frame: 24 hours
Derived pharmacokinetic parameter: Tlag
Tlag measures the delay between dosing and being able to observe the drug/metabolite within the sampling area (e.g., blood serum)
Time frame: 24 hours
Derived pharmacokinetic parameter: Cmax
Cmax measures the time taken for the drug/metabolite to reach maximum serum concentration
Time frame: 24 hours
Derived pharmacokinetic parameter: AUC(0 - t) (Area under the curve)
Area under the serum concentration versus time curve from time
Time frame: 24 hours
Derived pharmacokinetic parameter: AUC(0-∞)(Area under the curve)
Area under the serum concentration versus time curve from time = 0h extrapolated to infinity
Time frame: 24 hours
Derived pharmacokinetic parameter: CL
Time to drug clearance
Time frame: 24 hours
Derived pharmacokinetic parameter: T1/2
Time required to reach 1/2 Cmax
Time frame: 24 hours
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
The record gives a start of Mar 2010, a primary completion of Apr 2010 and a completion of Apr 2010. It does not say whether these dates are actual or estimated.
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
Adrenal Hyperplasia, Congenital →