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Can a Modified-Release hydrocortisone mimic the Body's natural rhythm?

NCT ID NCT03343327

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

25 people

The number who actually took part.

Started

Feb 2018

Finished

Apr 2018

Lead sponsor

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

18 to 45 years

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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

  • Simbec Research Ltd.

    Merthyr Tydfil, CF48 4DR, United Kingdom

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