An investigation into the administration of Infacort® in human adult volunteers

Active, not recruiting

• Conditions: Adrenal Insufficiency; MedDRA version: 14.1Level: LLTClassification code 10001369Term: Adrenal insufficiency NOSSystem Organ Class: 100000004860; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2013-000260-28-GB
• Lead Sponsor: Diurnal Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-17
• Last Update Posted: 17 February 2014

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: Male
• Target Recruitment: 16

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 urine examination values within 14 days prior to the first dose.
•Subjects with a negative urinary drugs of abuse screen, determined within 14 days prior to the first dose.
•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 the first dose.
•Subjects with no clinically-significant deviation outside the normal ranges for blood pressure and pulse measurements.
•Subjects 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.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 16
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

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 (including high dose vitamins, dietary supplements or herbal remedies).
•Receipt of any vaccination within 14 days prior to the first dose.
•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 16 weeks or a marketed drug clinical study within the previous 12 weeks. (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 the first dose or have consumed any alcohol within the 48 hour period prior to the first dose.
•Donation of 450ml or more of blood within the previous 12 weeks.
•Subjects who smoke (or ex-smokers who have smoked within 6 months prior to first dose).
•Subjects who work shifts (i.e. regularly alternate between days, afternoons and nights).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified