Effect of Slow Release Hydrocortisone on Fed & Fasting Volunteers; Immediate Release on Fasting Only
Condition: Healthy
Intervention: Dexamethasone; Chronocort: fasted; Immediate release hydrocortisone: fasted; Chronocort: fed
Intervention description: 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
Intervention MeSH terms: Dexamethasone; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: Male
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: subjects

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.
    

Eligibility 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 Human Immunodeficiency Virus (HIV) and Hepatitis b & C results

          -  No clinically significant abnormalities in 12-lead Electrocardiogram (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)