Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Hydrocortisone granules
Infacort · 5 trials · 1 indication
The primary endpoint was the nature and occurrence of serious adverse events (SAEs) and adverse events (AEs) observed throughout the study. AEs were recorded from the time of the first intake of Infacort until the final visit.
The primary endpoint will be the maximum levels of serum cortisol concentration up to 240 minutes after intake of study drug as determined by the central laboratory.
Comparing the maximum serum cortisol concentration (Cmax) of Infacort® compared to Cortef® immediate release hydrocortisone tablets.This PK endpoint will be derived from baseline adjusted and unadjusted serum cortisol concentration-time data following administration of each IMP.
Comparing the total drug exposure over time for Infacort® compared to Cortef®. This PK endpoint will be derived from baseline adjusted and unadjusted serum cortisol concentration-time data following administration of each IMP.
Comparing the total drug exposure over time for Infacort® compared to Cortef® extrapolated to infinity from dosing time, based on the last observed concentration. This This PK endpoint will be derived from baseline adjusted and unadjusted serum cortisol concentration-time data following administration of each IMP.
The pharmacokinetic parameter AUC0-inf of Infacort® administered as sprinkles with yoghurt and soft food compared to Infacort® administered as dry granules to the back of the tongue.
The pharmacokinetic parameter AUC0-inf of Infacort® administered as sprinkles with yoghurt and soft food compared to Infacort® administered as dry granules to the back of the tongue.
The pharmacokinetic parameter Cmax of Infacort® administered as sprinkles with yoghurt and soft food compared to Infacort® administered as dry granules to the back of the tongue.
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 |
|---|---|---|
| Infacort | EXPERIMENTAL | Infacort® granules |
| Cortef® Tablets - fasted | ACTIVE_COMPARATOR | Single dose of 20mg Cortef® Tablets - fasted arm |
| Infacort® - fasted | EXPERIMENTAL | Single dose of 20mg Infacort® - fasted arm |
| Cortef® Tablets - fed | ACTIVE_COMPARATOR | Single dose of 20mg Cortef® Tablets - fed arm |
| Infacort® - fed | EXPERIMENTAL | Single dose of 20mg Infacort® - fed arm |
| Infacort - Yoghurt | EXPERIMENTAL | One single 5mg dose of Infacort will be sprinkled onto 5mL of yoghurt and swallowed within three minutes. This will be taken with 240mL of water. |
| Infacort - Soft Food | EXPERIMENTAL | One single 5mg dose of Infacort will be sprinkled onto 5mL of soft food (such as applesauce) and swallowed within three minutes. This will be taken with 240mL of water. |
| Infacort - Dry Granules | ACTIVE_COMPARATOR | One single 5mg dose of Infacort will be administered as dry granules to the back of the tongue and swallowed. This will be taken with 240mL of water. |
| 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 |
|---|---|---|
| Infacort® | DRUG | Infacort® is a dry granule formulation of hydrocortisone stored in capsules available in different strengths (0.5, 1.0, 2.0 and 5.0 mg). |
| Cortef® | DRUG | Immediate release hydrocortisone tablets |
| Infacort | DRUG | Immediate-release multiparticulate formulation of hydrocortisone. |
| 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: Subjects successfully completing study Infacort 003, whose inclusion criteria were: 1. Male and female children less than 6 years of age. 2. A diagnosis of adrenal insufficiency (AI) as confirmed by an inappropriately low cortisol usually with other supporting tests. 3. Receivi...
Infacort is used to treat adrenal insufficiency, a condition in which the body does not produce enough of the hormone cortisol. It is being developed for both children and adults, with clinical trials enrolling patients from as young as one week old through adulthood. It is an oral small molecule therapy.
Infacort is being developed by Neurocrine Biosciences, Inc., which trades on the Nasdaq under the ticker NBIX. The company holds the development program for this adrenal insufficiency therapy.
Infacort is in Phase 3 clinical development for adrenal insufficiency. It is investigational and has not been approved by the FDA. Four clinical trials have been completed, including two Phase 3 studies and two Phase 1 studies, with no trials currently active.
Infacort has been studied in four completed trials. These include NCT02720952, a Phase 3 study of adrenal insufficiency treatment in children in Germany, and its extension study NCT02733367. Phase 1 trials NCT03311932 and NCT03178214 evaluated Infacort in healthy adult volunteers in the United Kingdom.
Yes, Infacort and Infacort® refer to the same product. Infacort® is the registered trademark form of the name used by Neurocrine Biosciences, Inc. for its adrenal insufficiency therapy. Both names describe the same oral small molecule treatment candidate.
Across the four completed Infacort clinical trials, a total of 112 participants have been enrolled. The studies include both healthy adult volunteers and patients with adrenal insufficiency, with enrollment ranging from 18 to 51 participants per trial.