Can a modified hydrocortisone mimic the Body's natural cortisol rhythm?
NCT ID NCT03019614
First seen Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time
Summary
Researchers are testing Chronocort, a modified-release form of hydrocortisone, against standard immediate-release hydrocortisone in 30 healthy male volunteers. The study measures how the drug moves through the body, including how fast it reaches peak levels and how long it stays in the blood. The goal is to see whether Chronocort releases hydrocortisone in a way that better matches the body's natural daily cortisol pattern, which could matter for people with adrenal insufficiency or congenital adrenal hyperplasia.
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 formulation of hydrocortisone
- What this could lead to
- If Chronocort releases hydrocortisone in a more natural rhythm, it could offer people with adrenal insufficiency or congenital adrenal hyperplasia a treatment that better mimics the body's own cortisol pattern.
- What could go wrong
- This is a small, single-dose Phase 1 study in healthy men, so it cannot show whether Chronocort improves symptoms or long-term outcomes. The results may not apply to women, children, or people who actually have adrenal disease.
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
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30 people
The number who actually took part.
- Start date
-
Mar 2010
- Finished
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Apr 2010
- 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
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18 to 60 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: * 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. * 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. Exclusion Criteria: * 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). * 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).
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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.
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