Effect of Slow Release Hydrocortisone on Fed & Fasting Volunteers; Immediate Release on Fasting Only
Condition: Healthy
Study type: Interventional
Phase: Phase 1

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.
    

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 Human Immunodeficiency Virus (HIV), drug abuse and Electrocardiograms (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.
      Further dexamethasone doses will be given at 06:00, 12:00, and 18:00 hours on Day 1 (plus at
      22:00 hours in patients given the modified release study drug). 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 Pharmacokinetic
      (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.
    

Intervention name(s): Dexamethasone; Chronocort: fasted; Immediate release hydrocortisone: fasted; Chronocort: fed
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Dexamethasone used to suppress endogenous cortisol secretion; single dose of 20mg modified release hydrocortisone in the absence of food; single dose of 20mg immediate release hydrocortisone in the absence of food; single dose of 20mg modified release hydrocortisone in the presence of food
Other intervention name(s): modified release hydrocortisone; Hydrocortisone; modified release hydrocortisone
Intervention MeSH terms: Dexamethasone; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: subjects