Can a Modified-Release hydrocortisone mimic the Body's natural rhythm?
NCT ID NCT03343327
First seen Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time
Summary
Researchers are testing how the body absorbs Chronocort, a modified-release hydrocortisone, compared with Cortef, a standard immediate-release hydrocortisone tablet. The study enrolls healthy adult men whose natural cortisol production is temporarily suppressed with dexamethasone. Each participant receives a single 20 mg dose of each tablet in a crossover design, and researchers measure cortisol levels in the blood over time to compare bioavailability.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Chronocort, a modified-release hydrocortisone formulation, compared with Cortef immediate-release hydrocortisone tablets
- What this could lead to
- If Chronocort releases hydrocortisone more steadily than standard tablets, it could offer people with adrenal insufficiency a dosing schedule that better mimics the body's natural cortisol rhythm.
- What could go wrong
- This is a small Phase 1 study in healthy men, so it cannot show whether Chronocort improves symptoms or long-term outcomes in people with adrenal insufficiency. Results may not apply to women, children, or older adults.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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25 people
The number who actually took part.
- Started
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Feb 2018
- Finished
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Apr 2018
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 45 years
- Sex
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Male participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Healthy male subjects between 18 and 45 years of age inclusive (at screening). 2. A BMI of 18-30 kg/m2 (inclusive). 3. No clinically significant abnormal serum biochemistry, haematology or urine examination values as defined by the Investigator. 4. 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. 5. Negative HIV and Hepatitis Band C results. 6. No clinically significant abnormalities in 12-lead ECG as defined by the Investigator. 7. No clinically significant deviation outside the normal ranges for blood pressure and heart rate measurements as defined by the Investigator. 8. 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 9. Subjects must be available to complete both periods of the study and the follow-up visit. 10. Subjects must satisfy a medical examiner about their fitness to participate in the study. 11. Subjects must be able to read and understand the informed consent form and must provide written informed consent to participate in the study. Exclusion Criteria: 1. A clinically significant history of gastrointestinal disorder likely to influence drug absorption. 2. 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). 3. Evidence of renal. hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction. 4. Receipt of any vaccination within the previous one month. 5. Presence of infections (systemic fungal and viral infections, acute bacterial infections). 6. Current or previous history of tuberculosis. 7. A clinically significant history of previous allergy/sensitivity to hydrocortisone and/or dexamethasone. 8. 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 9. A clinically significant history of drug or alcohol abuse. 10. Inability to communicate well with the Investigator (i.e., language problem, poor mental development or impaired cerebral function). 11. 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). 12. 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. 13. Donation or receipt of 450 mL of blood within the previous three months. 14. Subjects who smoke (or ex-smokers who have smoked within six months prior to first dose). This includes e-cigarette and shisha users. 15. Subjects who work shifts (i.e. regularly alternate between days, afternoons and nights).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Simbec Research Ltd.
Merthyr Tydfil, CF48 4DR, United Kingdom
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Other studies related to the condition(s) this trial covers.
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