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
Summary
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 eventsArea 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Male.
Criteria:
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
dose
- 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
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