Effect of Slow Release Hydrocortisone on Fed & Fasting Volunteers; Immediate Release on Fasting Only

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: Male

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.

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

Details

• Lead Sponsor: Diurnal Limited
• Collaborator: Simbec Research
• Treatments: BB 1101; Cortisol succinate; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate

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)