An Investigational Study of Hydrocortisone
Condition: Adrenal Insufficiency
MeSH terms: Adrenal Insufficiency
Intervention: Hydrocortisone granules; Hydrocortisone Tablet; i.v. Hydrocortisone Injection; Dexamethasone
Intervention description: Multi-particulate granules; Standard hydrocortisone tablets; Standard hydrocortisone solution for intravenous injection; Challenge agent
Intervention MeSH terms: Dexamethasone; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: Male
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will investigate a new drug called Infacort®; a newly-developed immediate release
      formulation of a well-established drug called hydrocortisone. Hydrocortisone is used as a
      replacement treatment for people whose adrenal glands are not producing enough natural
      cortisol - a condition known as adrenal insufficiency. The study will assess how Infacort®
      acts once inside the body, by measuring cortisol and other hormone levels in the body,
      compared to already marketed hydrocortisone tablet and hydrocortisone intravenous (through
      the vein) injection.

      The population who are eligible to take part in the study are healthy male volunteers, aged
      between 18 and 60 years of age.
    

Eligibility criteria:

        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
             urinalysis values within 14 days prior to Day 1 of Study Period 1.

          -  Subjects with a negative urinary drugs of abuse screen, determined within 14 days
             prior to Day 1 of Study Period 1. A positive alcohol test may be repeated at the
             discretion of the Investigator.

          -  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 Day 1 of Study Period 1.

          -  Subjects with 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 (IUD) + condom

               -  Diaphragm with spermicide + condom

          -  Subjects must be available to complete the study.

          -  Subjects must satisfy a medical examiner about their fitness to participate in 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 within 14 days prior to Day 1 of Study Period 1
             (including high dose vitamins, dietary supplements or herbal remedies).

          -  Receipt of any vaccination within 14 days prior to Day 1 of Study Period 1.

          -  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 4 months or
             a marketed drug clinical study within the previous 3 months. (N.B. The washout period
             between trials is 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 Day 1 of Study Period 1or have consumed any alcohol within the 48 hour period
             prior to Day 1 of Study Period 1.

          -  Donation of 450ml or more of blood within the previous 3 months.

          -  Subjects who smoke (or ex-smokers who have smoked within 6 months prior to Day 1 of
             Study Period 1).

          -  Subjects who work shifts (i.e. regularly alternate between days, afternoons and
             nights).