Congenital Adrenal HyperplasiaPhase 1NCT03019614
An Open Label Study in Healthy Volunteers to Compare Chronocort® to Hydrocortisone
A Phase 1 study testing Hydrocortisone and Chronocort in people with Congenital Adrenal Hyperplasia and Adrenal Insufficiency, run by Neurocrine UK Limited.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Congenital Adrenal Hyperplasia, Adrenal Insufficiency
- What is being tested?
- Hydrocortisone and Chronocort
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Mar 2010to Apr 2010
- 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 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteers between 18 and 60 years of age, inclusive (at screening).
- Subjects with a Body Mass Index (BMI) of 21-28. Body Mass Index = Body weight (kg) / (Height (m))2.
- Subjects with no clinically significant abnormal serum biochemistry, haematology and urine examination values within 14 days of the start of the study. The parameters measured included those shown in Appendix 3 of the Study Protocol.
- Subjects with a negative urinary drugs of abuse screen (including alcohol), determined within 14 days of the start of the study.
- Subjects with negative HIV and Hepatitis B and C results.
- Subjects with no clinically significant abnormalities in 12-lead electrocardiogram (ECG) determined within 14 days of the start of the study.
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- Subjects with no clinically-significant deviation outside the normal ranges for blood pressure and pulse measurements.
- Subjects and sexual partners must have used effective contraception methods during the trial and for 3 months after the last dose, for example:
- Oral contraceptive + condom
- Intra-uterine device (IUD) + condom
- Diaphragm with spermacide + condom
- Subjects must have been available to complete the study.
- Subjects must have satisfied a medical examiner about their fitness to participate in the study.
- Subjects must have provided 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 regular medication within 14 days of the first study day (including high dose vitamins, dietary supplements or herbal remedies).
- Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction.
- A clinically significant history of previous allergy / sensitivity to Hydrocortisone.
- 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).
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- Participation in a New Chemical Entity clinical study within the previous 16 weeks or a marketed drug clinical study within the previous 12 weeks.
- Subjects who had consumed more than 2 units of alcohol per day within seven (7) days prior to the first dose or had consumed any alcohol within the 48 hour period prior to the first dose.
- Donation of 450ml or more blood within the previous 12 weeks.
- Subjects who worked shifts (i.e. regularly alternated between days, afternoons and nights).
About this study
Official title: An Open Label, Randomised, Single Dose, 3-period Crossover Study in Healthy Volunteers to: a) Compare the Pharmacokinetics of Chronocort® Formulations Versus Immediate Release Hydrocortisone, and (b) Determine the Dose Proportionality of Chronocort® Formulations
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).
- Being tested
- Hydrocortisone, Chronocort
- Medical subject headings
- Adrenal Hyperplasia, Congenital, Adrenal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydrocortisoneDrug
Generic hydrocortisone
ChronocortDrug
Modified formulation of hydrocortisone
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | 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. Receives: Drug: Hydrocortisone; Drug: Chronocort |
| Group 2 | Experimental | 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. Receives: Drug: Chronocort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Derived pharmacokinetic parameter: Tmax
Tmax measures the time at which Cmax - maximum serum concentration - is observed
Measured: 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)
Measured: 24 hours
Derived pharmacokinetic parameter: Cmax
Cmax measures the time taken for the drug/metabolite to reach maximum serum concentration
Measured: 24 hours
Derived pharmacokinetic parameter: AUC(0 - t) (Area under the curve)
Area under the serum concentration versus time curve from time
Measured: 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
Measured: 24 hours
Derived pharmacokinetic parameter: CL
Time to drug clearance
Measured: 24 hours
Derived pharmacokinetic parameter: T1/2
Time required to reach 1/2 Cmax
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2017 (estimated)
- Study startMar 2010
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Adrenal HyperplasiaStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurocrine UK Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Simbec Research
- Responsible party
- Sponsor
- Investigators
- Salvatore Febbraro, Principal investigator, Simbec Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03019614
- Sponsor's protocol ID
- DIUR-001
- Status last verified
- Sep 2026
- First submitted
- 11 Jan 2017
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- 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
- An Open Label, Randomised, Single Dose, 3-period Crossover Study in Healthy Volunteers to: a) Compare the Pharmacokinetics of Chronocort® Formulations Versus Immediate Release Hydrocortisone, and (b) Determine the Dose Proportionality of Chronocort® Formulations
- ClinicalTrials.gov ID
- NCT03019614
- Acronym / sponsor ID
- DIUR-001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Neurocrine UK LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Simbec Research
- Study start
- Mar 2010
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 12 Jan 2017 (estimated)
- 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 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Hydrocortisone, Drug: ChronocortVolunteers 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. |
| Group 2 | Experimental | Drug: ChronocortVolunteers 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Healthy male volunteers between 18 and 60 years of age, inclusive (at screening).
- Subjects with a Body Mass Index (BMI) of 21-28. Body Mass Index = Body weight (kg) / (Height (m))2.
- Subjects with no clinically significant abnormal serum biochemistry, haematology and urine examination values within 14 days of the start of the study. The parameters measured included those shown in Appendix 3 of the Study Protocol.
- Subjects with a negative urinary drugs of abuse screen (including alcohol), determined within 14 days of the start of the study.
- Subjects with negative HIV and Hepatitis B and C results.
Key exclusion criteria (10 listed)
- A clinically significant history of gastrointestinal disorder likely to influence drug absorption.
- Receipt of regular medication within 14 days of the first study day (including high dose vitamins, dietary supplements or herbal remedies).
- Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction.
- A clinically significant history of previous allergy / sensitivity to Hydrocortisone.
- A clinically significant history of drug or alcohol abuse.
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 |
|---|---|---|
| HydrocortisoneGeneric hydrocortisone | Drug | Group 1 |
| ChronocortModified formulation of hydrocortisone | Drug | Group 1, Group 2 |
Primary outcome
Derived pharmacokinetic parameter: Tmax
Time frame: 24 hours
Tmax measures the time at which Cmax - maximum serum concentration - is observed
Derived pharmacokinetic parameter: Tlag
Time frame: 24 hours
Tlag measures the delay between dosing and being able to observe the drug/metabolite within the sampling area (e.g., blood serum)
Derived pharmacokinetic parameter: Cmax
Time frame: 24 hours
Cmax measures the time taken for the drug/metabolite to reach maximum serum concentration
Derived pharmacokinetic parameter: AUC(0 - t) (Area under the curve)
Time frame: 24 hours
Area under the serum concentration versus time curve from time
Derived pharmacokinetic parameter: AUC(0-∞)(Area under the curve)
Time frame: 24 hours
Area under the serum concentration versus time curve from time = 0h extrapolated to infinity
Derived pharmacokinetic parameter: CL
Time frame: 24 hours
Time to drug clearance
Derived pharmacokinetic parameter: T1/2
Time frame: 24 hours
Time required to reach 1/2 Cmax
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.
Salvatore Febbraro principal investigator
Simbec Research
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Hydrocortisone and Chronocort in people with Congenital Adrenal Hyperplasia and Adrenal Insufficiency, run by Neurocrine UK Limited.
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 10 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.
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?
Derived pharmacokinetic parameter: Tmax (time frame: 24 hours). 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 14 Sep 2026.