Congenital Adrenal Hyperplasia, Adrenal Insufficiency
Conditions
Brief summary
This was an open label, randomized, single dose, three period crossover pharmacokinetic study of Chronocort® in 30 healthy male volunteers. The study was conducted in smaller sub groups (Group 1, n=18 and Group 2, n=12).
Interventions
DRUGHydrocortisone
Generic hydrocortisone
DRUGChronocort
Modified formulation of hydrocortisone
Sponsors
Simbec Research
Neurocrine UK Limited
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
Yes
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 of the start of the study. The parameters measured included those shown in Appendix 3 of the Study Protocol. * Subjects with a negative urinary drugs of abuse screen (including alcohol), determined within 14 days of the start of the study. * 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 of the start of the study. * Subjects with no clinically-significant deviation outside the normal ranges for blood pressure and pulse measurements. * Subjects and sexual partners must have used 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 spermacide + condom * Subjects must have been available to complete the study. * Subjects must have satisfied a medical examiner about their fitness to participate in the study. * Subjects must have 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 of the first study day (including high dose vitamins, dietary supplements or herbal remedies). * Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction. * A clinically significant history of previous allergy / sensitivity to Hydrocortisone. * 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. * Subjects who had consumed more than 2 units of alcohol per day within seven (7) days prior to the first dose or had consumed any alcohol within the 48 hour period prior to the first dose. * Donation of 450ml or more blood within the previous 12 weeks. * Subjects who worked shifts (i.e. regularly alternated between days, afternoons and nights).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Derived pharmacokinetic parameter: Tmax | 24 hours | Tmax measures the time at which Cmax - maximum serum concentration - is observed |
| Derived pharmacokinetic parameter: Tlag | 24 hours | Tlag measures the delay between dosing and being able to observe the drug/metabolite within the sampling area (e.g., blood serum) |
| Derived pharmacokinetic parameter: Cmax | 24 hours | Cmax measures the time taken for the drug/metabolite to reach maximum serum concentration |
| Derived pharmacokinetic parameter: AUC(0 - t) (Area under the curve) | 24 hours | Area under the serum concentration versus time curve from time |
| Derived pharmacokinetic parameter: AUC(0-∞)(Area under the curve) | 24 hours | Area under the serum concentration versus time curve from time = 0h extrapolated to infinity |
| Derived pharmacokinetic parameter: CL | 24 hours | Time to drug clearance |
| Derived pharmacokinetic parameter: T1/2 | 24 hours | Time required to reach 1/2 Cmax |
Outcome results
None listed