Can a Timed-Release hydrocortisone pill match the Body's overnight hormone rhythm?
NCT ID NCT03051893
First seen Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time
Summary
Researchers are testing several modified, timed-release versions of hydrocortisone, a hormone drug, in healthy male volunteers. The study has two parts: one compares how six different formulations move through the body after a single nighttime dose, and the other checks whether three dose levels behave predictably. Participants receive the drug in a random order with a one-week gap between doses, and researchers measure blood levels over 18 to 24 hours. The goal is to learn which formulation best mimics the body's natural cortisol pattern, which could matter for conditions like adrenal insufficiency.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a modified, timed-release form of hydrocortisone called Chronocort
- What this could lead to
- If the timed-release design works, it could offer people with adrenal insufficiency or congenital adrenal hyperplasia a hydrocortisone pill that better mimics the body's natural overnight cortisol rise.
- What could go wrong
- This is a small Phase 1 study in healthy men, so it cannot show whether the formulation controls symptoms or works in patients. Results may not carry over to women, children, or people with these conditions.
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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
-
28 people
The number who actually took part.
- Start date
-
Feb 2011
- Finished
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Apr 2012
- 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 60 years
- Sex
-
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 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. * 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. Exclusion Criteria: * 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 * 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).
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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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Other studies related to the condition(s) this trial covers.
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