Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02408068 | Effect of Slow Release Hydrocortisone on Fed & Fasting Volunteers; Immediate Release on Fasting Only | PHASE1 | COMPLETED | 18 | — | — | Jan 1, 2015 | Mar 1, 2015 | May 4, 2022 | - | — |
Comparison of fed and fasted Chronocort Cmax for serum cortisol.
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.
Comparison of Fed and Fasted Chronocort based on the time to achive the maximum concentration of serum cortisol
Evaluation of the relative bioavailability of Chronocort® and immediate release hydrocortisone at a single dose of 20 mg in the fasted state by Cmax
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
To evaluate the relative bioavailability of Chronocort® and immediate release hydrocortisone at a single dose of 20 mg in the fasted state using Tmax.
| Arm | Type | Description |
|---|---|---|
| Chronocort : fed | ACTIVE_COMPARATOR | 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). |
| Immediate release hydrocortisone: fasted | ACTIVE_COMPARATOR | 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) |
| Chronocort: fasted | ACTIVE_COMPARATOR | 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) |
| Name | Type | Description |
|---|---|---|
| Dexamethasone | DRUG | Dexamethasone used to suppress endogenous cortisol secretion |
| Chronocort: fasted | DRUG | single dose of 20mg modified release hydrocortisone in the absence of food |
| Immediate release hydrocortisone: fasted | DRUG | single dose of 20mg immediate release hydrocortisone in the absence of food |
| Chronocort: fed | DRUG | single dose of 20mg modified release hydrocortisone in the presence of food |
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 a...