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Effect of Slow Release Hydrocortisone on Fed & Fasting Volunteers; Immediate Release on Fasting Only

Information source: Diurnal Limited
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Dexamethasone (Drug); Chronocort: fasted (Drug); Immediate release hydrocortisone: fasted (Drug); Chronocort: fed (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Diurnal Limited


The purpose of the study is to find out whether food has an effect on the way the body deals with modified release hydrocortisone, and to compare with the pharmacokinetics of immediate release hydrocortisone (fasted). This information will be used to help doctors with dosing in clinical practice.

Clinical Details

Official title: Open Label Randomised 3 Period Crossover Study to Evaluate Bioavailability of Modified Release Hydrocortisone (HC) Under Fasting & Fed Conditions & Immediate Release HC Tablets Under Fasting Conditions in Dexamethasone-suppressed Subjects

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome:

Area under the plasma concentration versus time curve (AUC) (Comparison of fed and fasted Chronocort AUC)

Peak Plasma Concentration (Cmax) (Comparison of fed and fasted chronocort Cmax)

Secondary outcome:

Assessment of safety and tolerability of Chronocort and Immediate Release hydrocortisone under fasting conditions assessed by number of adverse events

Area under the plasma concentration versus time curve (AUC) (Comparison of Chronocort and IR hydrocortisone AUC)

Peak Plasma Concentration (Cmax) (Comparison of Chronocort and IR hydrocortisone Cmax)

Detailed description: This is a phase I study in healthy male volunteers, who will be given dexamethasone to suppress their natural cortisol production. 18 will be consented for the study. They will have had a history and a physical examination, blood tests for routine safety, hepatitis C and HIV, drug abuse and ECGs. Following the results of these tests and the inclusion/exclusion criteria for the study, they will be admitted to the phase I unit on the

first afternoon (Day - 1). They will be given dexamethasone at 22. 00hrs that evening, and

remain in the unit until the end of the period. Each volunteer will be admitted for 3 periods of approximately 1. 5 days, with a washout of 7 days between periods, and they will be randomised to either fast and take a single 20mg dose of immediate release hydrocortisone, to fast and take a single 20mg dose of the study medication, (a modified release hydrocortisone), or to the "fed" group, where they take a single dose of 20mg study medication, and have a highly calorific standardised breakfast. The volunteers will have cannulae to enable one pre-dose blood sample to be taken followed by 24 hour PK sampling (modified release) and 12 hour PK sampling for the immediate release period. After these samples have been taken the volunteers will be able to leave the unit. There will be another assessment 3 to 5 days after study period 3 with further blood tests, assessment of any adverse events etc.


Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Male.


Inclusion Criteria:

- Healthy male volunteers between 18 and 60 years of age, inclusive (at screening)

- A body mass index of 21-28 (inclusive).

- No clinically significant abnormal serum biochemistry, haematology and urine

examination values

- A negative urinary drugs of abuse screen. A positive alcohol test may be repeated at

the discretion of the investigator.

- Negative HIV and Hepatitis b & C results

- No clinically significant abnormalities in 12-lead ECG

- No clinically significant deviation outside the normal ranges for blood pressure and

pulse measurements

- 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 effective contraception methods during the trial and for 3 months after the last dose, for example:

- Oral contraceptive + condom

- Intra-uterine device + condom

- Diaphragm with spermicide + condom

- Subjects must be available to complete the study

- Subjects must provide 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 (including high dose vitamins, dietary supplements or

herbal remedies)

- Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or

metabolic dysfunction Receipt of any vaccination within the previous one month

- Presence of clinically significant infections (systemic fungal and viral infections,

acute bacterial infections)

- Current of previous history of tuberculosis

- A clinically significant history of previous allergy/sensitivity to hydrocortisone

and/or dexamethasone

- A clinically significant history of family history of psychiatric disorders/illnesses

- A clinically significant history of drug or alcohol abuse

- Inability to communicate well with the investigator (ie language problem, poor mental

development or impaired cerebral function)

- Participation in a New Chemical entity clinical study within the previous four months

or a marketed drug clinical study within the previous three months

- Subjects who have consumed more than two units of alcohol pre day within seven days

prior to the first dose or have consumed any alcohol within the 48hr period prior to the first dose

- Donation of greater than or equal to 450ml blood within the previous three months

- Subjects who smoke or ex-smokers who have smoked within six months prior to first


- Subjects who work shifts (ie regularly alternate between days, afternoons and nights)

Locations and Contacts

Additional Information

Starting date: January 2015
Last updated: April 2, 2015

Page last updated: August 23, 2015

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