Comparison of Pharmacokinetics of Infacort® Versus Immediate-release Hydrocortisone

• Status: Completed
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: Male

Summary

This was a single centre, open-label, randomised, 5-way crossover study.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Diurnal Limited
• Collaborator: Simbec Research
• Treatments: Cortisol succinate; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate

Criteria

Inclusion Criteria:

• Healthy male volunteers between 18 and 60 years of age, inclusive (at Screening Visit).

• Subjects with a Body Mass Index (BMI) of 21-28.

• Subjects with no clinically significant abnormal serum biochemistry, haematology and urine examination values within 14 days prior to the first dose of investigational medicinal product (IMP).

• Subjects with a negative urinary drugs of abuse screen determined within 14 days prior to the first dose of IMP. A positive alcohol test may have been repeated at the discretion of the Investigator.

• Subjects with negative human immunodeficiency virus (HIV) and hepatitis B surface antigen (Hep B) and hepatitis C virus antibody (Hep C) results.

• Subjects with no clinically significant abnormalities in 12-lead electrocardiogram (ECG) determined within 14 days prior to the first dose of IMP.

• 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 was in-line with the preferred and usual lifestyle of the subject) and sexual partners used effective contraception methods during the trial and for 3 months after the last dose of IMP, for example; oral contraceptive + condom, intra-uterine device (IUD) + condom or diaphragm with spermicide + condom.

• Subjects were available to complete the study.

• Subjects satisfied a medical examiner about their fitness to participate in the study.

• Subjects provided 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 the first dose of IMP (including high dose vitamins, dietary supplements or herbal remedies).

• Receipt of any vaccination within 14 days prior to the first dose of IMP.

• 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).

• Participated 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 was 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 had consumed more than 2 units of alcohol per day within 7 days prior to the first dose of IMP or had consumed any alcohol within the 48 hr period prior to the first dose of IMP.

• Donation of 450 mL or more of blood within the previous 3 months.

• Subjects who smoked (or ex-smokers who had smoked within 6 months prior to first dose of IMP).

• Subjects who worked shifts (i.e. regularly alternated between days, afternoons and nights).