Adrenal InsufficiencyPhase 1NCT03051893
A Two-part, Study to Compare the Pharmacokinetics and Dose Proportionality of up to 6 Chronocort Formulations
A Phase 1 study testing Chronocort in people with Adrenal Insufficiency and Congenital Adrenal Hyperplasia, run by Neurocrine UK Limited.
Trial summary
This was an open label, randomised, single dose study, comprising Part A (undertaken in two separate three-period crossover cohorts denoted as A1 and A2) and Part B (undertaken in one four-period crossover cohort), to evaluate the PK of Chronocort® in healthy male volunteers. 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
- Adrenal Insufficiency, Congenital Adrenal Hyperplasia
- What is being tested?
- Chronocort
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- Feb 2011to Apr 2012
- 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 prior to the first dose.
- Subjects with negative urinary drugs of abuse screen determined within 14 days prior to the first dose.
- 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 prior to the first dose.
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- Subjects with no clinically-significant deviation outside the normal ranges for blood pressure and pulse measurements.
- Subjects and sexual partners used effective contraception methods during the trial and for 3 months after the last dose, for example:
- Oral contraceptive and condom
- Intra-uterine device (IUD) and condom
- Diaphragm with spermicide and condom
- Subjects were available to complete the study.
- Subjects satisfied a medical examiner about their fitness to participate in the study.
- Subjects provided written informed consent to participate in the study.
- Subject continued to meet all screening inclusion criteria prior to dosing.
- Subjects with no clinically significant abnormal serum biochemistry, haematology and urine examination values including negative urinary drugs of abuse screen (including alcohol) prior to dosing.
Who cannot join
- A clinically significant history of gastrointestinal disorder likely to influence drug absorption.
- Receipt of regular medication within 14 days prior to the first dose (including high dose vitamins, dietary supplements or herbal remedies).
- Receipt of any vaccination within 14 days prior to the first dose.
- Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction.
- Presence of clinically significant 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.
- A clinically significant history or family history of psychiatric disorders/illnesses.
- 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 within the previous 16 weeks or a marketed drug clinical study within the previous 12 weeks. (N.B. The washout period between trials was 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 2 units of alcohol per day within seven (7) days prior to the first dose or have consumed any alcohol within the 48 hour period prior to the first dose.
- Donation of 450ml or more of blood within the previous 12 weeks.
- Subjects who smoked (or ex-smokers who had smoked within 6 months prior to first dose).
- Subjects who worked shifts (i.e. regularly alternated between days, afternoons and nights).
About this study
Official title: A Two-part Open Label, Randomised, Single Dose, Crossover Study in Healthy Volunteers to: (Part A) Compare the Pharmacokinetics of up to 6 Chronocort® Formulations, and (Part B) Determine the Dose Proportionality of a Selected Chronocort® Formulation at Three Dose Levels With an Additional Comparison With the Selected Formulation Dosed on Two Occasions Over a 24 Hour Period
This was an open label, randomised, single dose study, comprising Part A (undertaken in two separate three-period crossover cohorts denoted as A1 and A2) and Part B (undertaken in one four-period crossover cohort), to evaluate the PK of Chronocort® in healthy male volunteers. The washout interval in both Part A and Part B was 1-week in between each treatment period.
- Being tested
- Chronocort
- Medical subject headings
- Adrenal Insufficiency, Adrenal Hyperplasia, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChronocortDrug
Modified formulation of hydrocortisone
| Study group | Role | What they receive |
|---|---|---|
| Part A1 | Experimental | Three formulations of Chronocort 30mg were administered to healthy volunteers, with a 7-day washout period between each dose. Each treatment was administered in a randomised, crossover manner. Receives: Drug: Chronocort |
| Part A2 | Experimental | Three additional formulations of Chronocort 30mg were administered to healthy volunteers, with a 7-day washout period between each dose. Each treatment was administered in a randomised, crossover manner. Receives: Drug: Chronocort |
| Part B | Experimental | The best formulation of Chronocort was then selected from Parts A1 \& A2. This was then administered in four separate treatment periods, in dosages of 5mg, 10mg, 20mg and 30mg. Each treatment was administered in a randomised, crossover manner. Receives: Drug: Chronocort |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the Tmax of six formulations of Chronocort® (30 mg, dosed at night) over an 18 hour period. Parts A1 & A2 only
Time at maximum concentration in serum
Measured: 18 hours
To compare the Cmax of six formulations of Chronocort® (30 mg, dosed at night) over an 18 hour period. Parts A1 & A2 only
Maximum serum concentration
Measured: 18 hours
To compare the AUC0-t of six formulations of Chronocort® (30 mg, dosed at night) over an 18 hour period.
Area under the plasma concentration-time curve
Measured: 18 hours
To compare the AUC0-∞ of six formulations of Chronocort® (30 mg, dosed at night) over an 18 hour period.
Area under the plasma concentration-time curve from zero (0) hours to infinity (∞)
Measured: 18 hours
To compare the CL of six formulations of Chronocort® (30 mg, dosed at night) over an 18 hour period.
Drug clearance (CL) is defined as the volume of plasma in the vascular compartment cleared of drug per unit time
Measured: 18 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2017
- Study startFeb 2011
- Primary completionApr 2012
- Study completionApr 2012
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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurocrine UK Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Simbec Research
- Responsible party
- Sponsor
- Investigators
- Girish Sharma, Principal investigator, Simbec Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03051893
- Sponsor's protocol ID
- DIUR-002
- 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
- A Two-part Open Label, Randomised, Single Dose, Crossover Study in Healthy Volunteers to: (Part A) Compare the Pharmacokinetics of up to 6 Chronocort® Formulations, and (Part B) Determine the Dose Proportionality of a Selected Chronocort® Formulation at Three Dose Levels With an Additional Comparison With the Selected Formulation Dosed on Two Occasions Over a 24 Hour Period
- ClinicalTrials.gov ID
- NCT03051893
- Acronym / sponsor ID
- DIUR-002
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Neurocrine UK LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Simbec Research
- Study start
- Feb 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 14 Feb 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 an open label, randomised, single dose study, comprising Part A (undertaken in two separate three-period crossover cohorts denoted as A1 and A2) and Part B (undertaken in one four-period crossover cohort), to evaluate the PK of Chronocort® in healthy male volunteers. The washout interval in both Part A and Part B was 1-week in between each treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part A1 | Experimental | Drug: ChronocortThree formulations of Chronocort 30mg were administered to healthy volunteers, with a 7-day washout period between each dose. Each treatment was administered in a randomised, crossover manner. |
| Part A2 | Experimental | Drug: ChronocortThree additional formulations of Chronocort 30mg were administered to healthy volunteers, with a 7-day washout period between each dose. Each treatment was administered in a randomised, crossover manner. |
| Part B | Experimental | Drug: ChronocortThe best formulation of Chronocort was then selected from Parts A1 \& A2. This was then administered in four separate treatment periods, in dosages of 5mg, 10mg, 20mg and 30mg. Each treatment was administered in a randomised, crossover manner. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 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 prior to the first dose.
- Subjects with negative urinary drugs of abuse screen determined within 14 days prior to the first dose.
- Subjects with negative HIV and Hepatitis B and C results.
Key exclusion criteria (15 listed)
- A clinically significant history of gastrointestinal disorder likely to influence drug absorption.
- Receipt of regular medication within 14 days prior to the first dose (including high dose vitamins, dietary supplements or herbal remedies).
- Receipt of any vaccination within 14 days prior to the first dose.
- Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction.
- Presence of clinically significant 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 |
|---|---|---|
| ChronocortModified formulation of hydrocortisone | Drug | Part A1, Part A2, Part B |
Primary outcome
To compare the Tmax of six formulations of Chronocort® (30 mg, dosed at night) over an 18 hour period. Parts A1 & A2 only
Time frame: 18 hours
Time at maximum concentration in serum
To compare the Cmax of six formulations of Chronocort® (30 mg, dosed at night) over an 18 hour period. Parts A1 & A2 only
Time frame: 18 hours
Maximum serum concentration
To compare the AUC0-t of six formulations of Chronocort® (30 mg, dosed at night) over an 18 hour period.
Time frame: 18 hours
Area under the plasma concentration-time curve
To compare the AUC0-∞ of six formulations of Chronocort® (30 mg, dosed at night) over an 18 hour period.
Time frame: 18 hours
Area under the plasma concentration-time curve from zero (0) hours to infinity (∞)
To compare the CL of six formulations of Chronocort® (30 mg, dosed at night) over an 18 hour period.
Time frame: 18 hours
Drug clearance (CL) is defined as the volume of plasma in the vascular compartment cleared of drug per unit time
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.
Girish Sharma principal investigator
Simbec Research
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Chronocort in people with Adrenal Insufficiency and Congenital Adrenal Hyperplasia, 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 16 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.
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?
To compare the Tmax of six formulations of Chronocort® (30 mg, dosed at night) over an 18 hour period. Parts A1 & A2 only (time frame: 18 hours). The study lists 5 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.