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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02733367 | Extension Study for Patients Entered Into Study Infacort 003 | PHASE3 | COMPLETED | 18 | — | — | Mar 4, 2016 | Aug 10, 2018 | Nov 5, 2019 | 1 | Germany |
| NCT02720952 | Treatment of Adrenal Insufficiency in Children | PHASE3 | COMPLETED | 24 | — | — | Mar 1, 2015 | Jul 1, 2016 | May 4, 2022 | 1 | Germany |
| NCT03311932 | A Study of Infacort® Versus Cortef® in Healthy Adult Male and Female Subjects | PHASE1 | COMPLETED | 51 | — | — | Apr 16, 2018 | Jul 13, 2018 | Oct 29, 2019 | 1 | United Kingdom |
| NCT03178214 | Bioavailability of Infacort When Administered Onto Food Compared to Direct Oral Administration | PHASE1 | COMPLETED | 19 | — | — | May 22, 2017 | Jul 26, 2017 | Nov 9, 2017 | 1 | United Kingdom |
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.
| 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. |
| 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. |
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...