Status:
COMPLETED
A Study of Chronocort® Versus Cortef ® in Healthy Adult Male Subjects
Lead Sponsor:
Neurocrine UK Limited
Collaborating Sponsors:
Simbec Research
Brush Clinical Research Ltd.
Conditions:
Adrenal Insufficiency
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
This was a single centre, open label, randomised, two period, crossover study to evaluate the bioavailability of Chronocort® versus Cortef® immediate release hydrocortisone tablets in dexamethasone-su...
Detailed Description
This study was an open-label, randomised, single dose, two-period, crossover study in 25 healthy male subjects. The study comprised of a pre-study screen, followed by 2 treatment periods (1 and 2) an...
Eligibility Criteria
Inclusion
- Healthy male subjects between 18 and 45 years of age inclusive (at screening).
- A BMI of 18-30 kg/m2 (inclusive).
- No clinically significant abnormal serum biochemistry, haematology or urine examination values as defined by the Investigator.
- A negative urinary drugs of abuse screen. A positive alcohol test or drugs of abuse test may be repeated at the discretion of the Investigator.
- Negative HIV and Hepatitis Band C results.
- No clinically significant abnormalities in 12-lead ECG as defined by the Investigator.
- No clinically significant deviation outside the normal ranges for blood pressure and heart rate measurements as defined by the Investigator.
- 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 2 effective contraception methods during the trial and for 3 months after the last dose, for example:
- Oral, injected or implanted hormonal contraceptive+ condom
- Intra-uterine device (IUD) + condom
- Diaphragm with spermicide + condom
- Subjects must be available to complete both periods of the study and the follow-up visit.
- Subjects must satisfy a medical examiner about their fitness to participate in the study.
- Subjects must be able to read and understand the informed consent form and must provide written informed consent to participate in the study.
Exclusion
- A clinically significant history of gastrointestinal disorder likely to influence drug absorption.
- Receipt of any medication with the exception of paracetamol within the 14 days prior to dosing (including topical steroids, 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 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.
- Meeting any of the contraindications for Cortef® and/or dexamethasone, as detailed in the United States Prescribing Information (USPI)/Summary of Product Characteristics (SmPC), respectively
- 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 or a marketed drug clinical study within the previous three months, or five half- lives of the study drug, whichever is the longer period. (NB. the three-month 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 two units of alcohol per day within seven days prior to the first dose or have consumed any alcohol within the 48-hour period prior to the first dose.
- Donation or receipt of 450 mL of blood within the previous three months.
- Subjects who smoke (or ex-smokers who have smoked within six months prior to first dose). This includes e-cigarette and shisha users.
- Subjects who work shifts (i.e. regularly alternate between days, afternoons and nights).
Key Trial Info
Start Date :
February 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 20 2018
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT03343327
Start Date
February 19 2018
End Date
April 20 2018
Last Update
June 19 2020
Active Locations (1)
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1
Simbec Research Ltd.
Merthyr Tydfil, United Kingdom, CF48 4DR