- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02408068
Effect of Slow Release Hydrocortisone on Fed & Fasting Volunteers; Immediate Release on Fasting Only
Open Label Randomised 3 Period Crossover Study to Evaluate Bioavailability of Modified Release Hydrocortisone (HC) Under Fasting & Fed Conditions & Immediate Release HC Tablets Under Fasting Conditions in Dexamethasone-suppressed Subjects
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy male volunteers between 18 and 60 years of age, inclusive (at screening)
- A body mass index of 21-28 (inclusive).
- No clinically significant abnormal serum biochemistry, haematology and urine examination values
- A negative urinary drugs of abuse screen. A positive alcohol test may be repeated at the discretion of the investigator.
- Negative Human Immunodeficiency Virus (HIV) and Hepatitis b & C results
- No clinically significant abnormalities in 12-lead Electrocardiogram (ECG)
- No clinically significant deviation outside the normal ranges for blood pressure and pulse measurements
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 effective contraception methods during the trial and for 3 months after the last dose, for example:
- Oral contraceptive + condom
- Intra-uterine device + condom
- Diaphragm with spermicide + condom
- Subjects must be available to complete the study
- Subjects must provide 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 (including high dose 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 clinically significant infections (systemic fungal and viral infections, acute bacterial infections)
- Current of previous history of tuberculosis
- A clinically significant history of previous allergy/sensitivity to hydrocortisone and/or dexamethasone
- A clinically significant history of family history of psychiatric disorders/illnesses
- A clinically significant history of drug or alcohol abuse
- Inability to communicate well with the investigator (ie language problem, poor mental development or impaired cerebral function)
- Participation in a New Chemical entity clinical study within the previous four months or a marketed drug clinical study within the previous three months
- Subjects who have consumed more than two units of alcohol pre day within seven days prior to the first dose or have consumed any alcohol within the 48hr period prior to the first dose
- Donation of greater than or equal to 450ml blood within the previous three months
- Subjects who smoke or ex-smokers who have smoked within six months prior to first dose
- Subjects who work shifts (ie regularly alternate between days, afternoons and nights)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Chronocort : fed
Volunteers will be admitted, take dexamethasone at 22.00hrs, fast overnight, and receive a high fat, high calorie breakfast on the morning of Day 1. Thirty minutes after the start of the breakfast they will receive 20mg of modified release hydrocortisone with 200 millilitres of water, and no further food for 4 hours, water will be allowed from 1 hour after the food.
Further dexamethasone doses will be given at 06:00, 12:00, 18:00 and 22:00 hours on Day 1.
One baseline pharmacokinetics (PK) sample will be taken starting prior to the dose and then over 24 hours (29 samples).
|
Dexamethasone used to suppress endogenous cortisol secretion
single dose of 20mg modified release hydrocortisone in the presence of food
Other Names:
|
ACTIVE_COMPARATOR: Immediate release hydrocortisone: fasted
Volunteers will be admitted, take dexamethasone at 22.00hrs, fast overnight, and take 20mg immediate release hydrocortisone with 200 millilitres of water on the morning of Day 1. Water will be allowed 1hr after the study drug, but no food for at least 4hrs post dose.
Further dexamethasone doses will be given at 06:00, 12:00 and 18:00 hours on Day 1.
One baseline pharmacokinetics (PK) sample will be taken prior to the dose, and then afterwards for over a 12 hour period (16 samples)
|
Dexamethasone used to suppress endogenous cortisol secretion
single dose of 20mg immediate release hydrocortisone in the absence of food
Other Names:
|
ACTIVE_COMPARATOR: Chronocort: fasted
Volunteers will be admitted, take dexamethasone at 22.00hrs, fast overnight, and take 20mg modified release hydrocortisone with 200millilitres of water on the morning of Day 1. Water will be allowed 1hr after the dose, but no food for at least 4hrs post dose.
Further dexamethasone doses will be given at 06:00, 12:00, 18:00 and 22:00 hours on Day 1.
One baseline pharmacokinetics (PK) sample will be taken prior to the dose, and then afterwards for over a 12 hour period (16 samples)
|
Dexamethasone used to suppress endogenous cortisol secretion
single dose of 20mg modified release hydrocortisone in the absence of food
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Chronocort Cmax
Time Frame: 24 hours
|
Comparison of fed and fasted Chronocort Cmax for serum cortisol.
|
24 hours
|
Comparison of Fed and Fasted Chronocort AUC0-t
Time Frame: 24 hours (at 0h, then 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 6.5h, 7h, 7.5h, 8h, 9h, 10h, 11h, 12h, 13h, 14h, 15h, 16h, 18h, 20h, 22h and 24h post-dose.)
|
Area under the curve from 0 to 24 hours for serum cortisol. Please note that the AUC0-t will be presented as a single figure (geometric mean) to represent exposure over time. N.B., the sampling points for Hydrocortisone are as follows: 0h, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 10h and 12h post-dose. However, the results for Hydrocortisone will not be incorporated into the analysis for this outcome measure. |
24 hours (at 0h, then 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 6.5h, 7h, 7.5h, 8h, 9h, 10h, 11h, 12h, 13h, 14h, 15h, 16h, 18h, 20h, 22h and 24h post-dose.)
|
Comparison of Fed and Fasted Chronocort Tmax
Time Frame: 24 hours
|
Comparison of Fed and Fasted Chronocort based on the time to achive the maximum concentration of serum cortisol
|
24 hours
|
Bioavailability of Chronocort® vs Hydrocortisone Tablets - Cmax
Time Frame: 24 hours
|
Evaluation of the relative bioavailability of Chronocort® and immediate release hydrocortisone at a single dose of 20 mg in the fasted state by Cmax
|
24 hours
|
Bioavailability of Chronocort® vs Hydrocortisone Tablets - Fasted Using AUC0-t
Time Frame: 24 hours
|
To evaluate the relative bioavailability of Chronocort® and immediate release hydrocortisone at a single dose of 20 mg in the fasted state using area under the curve
|
24 hours
|
Bioavailability of Chronocort® vs Hydrocortisone Tablets - Fasted Using Tmax.
Time Frame: 24 hours
|
To evaluate the relative bioavailability of Chronocort® and immediate release hydrocortisone at a single dose of 20 mg in the fasted state using Tmax.
|
24 hours
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Dexamethasone
- Hydrocortisone
- Hydrocortisone 17-butyrate 21-propionate
- Hydrocortisone acetate
- Hydrocortisone hemisuccinate
Other Study ID Numbers
- DIUR-004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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