Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2025-12-24 @ 5:45 PM
NCT ID:
NCT02777268
Eligibility 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).
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT02777268
Study Brief:
Protocol Section:
NCT02777268