Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Hydrocortisone granules · 1 trial · 1 indication
Derived PK for Serum Cortisol: Maximum serum concentration (Cmax)
Derived PK for Serum Cortisol: Area under the curve from 0-24 hours
| Arm | Type | Description |
|---|---|---|
| Endogenous Cortisol | NO_INTERVENTION | No Study medication will be given during this study period, however various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points. |
| Dexamethasone | OTHER | 1mg Dexamethasone will be administered at 22:00 on Day 1 and at 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points. Dexamethasone is considered a challenge agent and therefore a non-IMP |
| Infacort® | EXPERIMENTAL | 20mg Infacort® will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous adrenocorticotropic Hormone (ACTH) and cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points. |
| Hydrocortisone Tablet | ACTIVE_COMPARATOR | 20mg Hydrocortisone Tablet will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous ACTH and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points. |
| i.v Hydrocortisone Injection | ACTIVE_COMPARATOR | 20mg i.v. Hydrocortisone Injection will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous ACTH and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points. |
| Name | Type | Description |
|---|---|---|
| Hydrocortisone granules | DRUG | Multi-particulate granules |
| Hydrocortisone Tablet | DRUG | Standard hydrocortisone tablets |
| i.v. Hydrocortisone Injection | DRUG | Standard hydrocortisone solution for intravenous injection |
| Dexamethasone | OTHER | Challenge agent |
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 urin...