Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
i.v. Hydrocortisone · 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...
i.v. Hydrocortisone is an investigational small molecule being developed for the treatment of adrenal insufficiency, a condition in which the adrenal glands do not produce enough cortisol. It is administered intravenously and is currently in Phase 1 clinical development.
i.v. Hydrocortisone is being developed by Neurocrine Biosciences, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol NBIX. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with adrenal insufficiency.
i.v. Hydrocortisone is in Phase 1 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. A Phase 1 clinical trial has been completed to assess its safety and pharmacokinetics in healthy volunteers.
i.v. Hydrocortisone has one completed clinical trial, identified as NCT01960530, titled 'An Investigational Study of Hydrocortisone.' This Phase 1 study enrolled 14 healthy male volunteers aged 18 years and older in the United Kingdom and was actively controlled.
i.v. Hydrocortisone is a formulation of hydrocortisone, a corticosteroid hormone, administered intravenously. It is being studied specifically for adrenal insufficiency. The drug is in Phase 1 development by Neurocrine Biosciences, Inc., and is not yet approved for clinical use.