An Open Label Study in Healthy Volunteers to Compare Chronocort® to Hydrocortisone
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group 1 Volunteers in group 1 received the following interventions: Chronocort® 30 mg given at night (~ 23:00h) as a combination of one 10mg capsule and one 20mg capsule (n=18). Chronocort® 30mg given as one 20mg capsule at night (~ 23:00h) and as one 10mg capsule in the morning (~ 7:00h) following the initial night-time dose (n=18). Hydrocortisone 30mg given at night (~ 23:00h) given as three 10mg tablets (n=18). Each administration of IMP was separated by a washout period of at least 7 days. |
Drug: Hydrocortisone
Generic hydrocortisone
Drug: Chronocort
Modified formulation of hydrocortisone
|
| Experimental: Group 2 Volunteers in group 2 received the following interventions: Chronocort® 5mg given at night (~ 23:00h) as one 5mg capsule (n=12). Chronocort® 10mg given at night (~ 23:00h) as one 10mg capsule (n=12). Chronocort® 20mg given at night (~ 23:00h) as one 20mg capsule (n=12). Each administration of IMP was separated by a washout period of at least 7 days. |
Drug: Chronocort
Modified formulation of hydrocortisone
|
Outcome Measures
Primary Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Healthy male volunteers between 18 and 60 years of age, inclusive (at screening).
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Subjects with a Body Mass Index (BMI) of 21-28. Body Mass Index = Body weight (kg) / (Height (m))2.
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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.
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Subjects with a negative urinary drugs of abuse screen (including alcohol), determined within 14 days of the start of the study.
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Subjects with negative HIV and Hepatitis B and C results.
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Subjects with no clinically significant abnormalities in 12-lead electrocardiogram (ECG) determined within 14 days of the start of the study.
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Subjects with no clinically-significant deviation outside the normal ranges for blood pressure and pulse measurements.
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Subjects and sexual partners must have used effective contraception methods during the trial and for 3 months after the last dose, for example:
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Oral contraceptive + condom
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Intra-uterine device (IUD) + condom
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Diaphragm with spermacide + condom
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Subjects must have been available to complete the study.
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Subjects must have satisfied a medical examiner about their fitness to participate in the study.
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Subjects must have provided written informed consent to participate in the study.
Exclusion Criteria:
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A clinically significant history of gastrointestinal disorder likely to influence drug absorption.
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Receipt of regular medication within 14 days of the first study day (including high dose vitamins, dietary supplements or herbal remedies).
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Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction.
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A clinically significant history of previous allergy / sensitivity to Hydrocortisone.
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A clinically significant history of drug or alcohol abuse.
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Inability to communicate well with the Investigator (i.e., language problem, poor mental development or impaired cerebral function).
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Participation in a New Chemical Entity clinical study within the previous 16 weeks or a marketed drug clinical study within the previous 12 weeks.
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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.
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Donation of 450ml or more blood within the previous 12 weeks.
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Subjects who worked shifts (i.e. regularly alternated between days, afternoons and nights).
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Diurnal Limited
- Simbec Research
Investigators
- Principal Investigator: Salvatore Febbraro, Simbec Research
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DIUR-001