Maximum Serum Concentration (Cmax)
| Group | Value (nmol/L) | Spread |
|---|---|---|
| Infacort® | 940.012 | 283.773 |
| Hydrocortisone Tablet | 896.489 | 258.083 |
| i.v Hydrocortisone Injection | 1563.479 | 491.267 |
Trial · Interventional
CompletedPhase 1Results postedRegistry dataThis trial does not test a peptide that PepBank tracks.
United Kingdom
1 trial · 1 completed · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This study will investigate a new drug called Infacort®; a newly-developed immediate release formulation of a well-established drug called hydrocortisone. Hydrocortisone is used as a replacement treatment for people whose adrenal glands are not producing enough natural cortisol - a condition known as adrenal insufficiency. The study will assess how Infacort® acts once inside the body, by measuring cortisol and other hormone levels in the body, compared to already marketed hydrocortisone tablet and hydrocortisone intravenous (through the vein) injection. The population who are eligible to take part in the study are healthy male volunteers, aged between 18 and 60 years of age.
No intervention
Endogenous Cortisol
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.
Other
Dexamethasone
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
Experimental
Infacort®
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.
Active comparator
Hydrocortisone Tablet
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.
Active comparator
i.v Hydrocortisone Injection
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.
Outcomes the sponsor listed as primary.
Maximum Serum Concentration (Cmax)
Time frame · Hourly from 0 to 24 hours
Derived PK for Serum Cortisol: Maximum serum concentration (Cmax)
AUC0-t
Time frame · Hourly from 0 to 24 hours
Derived PK for Serum Cortisol: Area under the curve from 0-24 hours
Adverse Events (AEs)
Time frame · Days 1-2 during each Study Period
Number of subjects with adverse events throughout the study.
Concentrations of Cortisol Binding Protein
Time frame · Blood samples on Day 1 and/or Day 2 of each Study Period
Cortisol protein binding under physiological conditions and after the administration of dexamethasone and hydrocortisone.
Insulin Sensitivity Under Physiological Conditions and After Administration of Dexamethasone and Infacort®, Hydrocortisone Tablets and i.v Hydrocortisone.
Time frame · Blood samples on Day 1 and/or Day 2 of each Study Period
A standardised mixed meal elevates blood glucose and provides a reproducible stimulation of insulin release. Lower levels of insulin secretion, whilst maintaining normoglycaemia would indicate enhanced insulin sensitivity and glucose disposal; higher insulin levels will reflect insulin resistance.
PK and Metabolism of Cortisol
Time frame · Blood, urine & saliva samples on Day 1 and/or Day 2 of each Study Period
Blood: Serum cortisol under physiological conditions and after administration of dexamethasone and Infacort® Granules, Hydrocortisone Tablets and i.v Hydrocortisone Injection.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (nmol/L) | Spread |
|---|---|---|
| Infacort® | 940.012 | 283.773 |
| Hydrocortisone Tablet | 896.489 | 258.083 |
| i.v Hydrocortisone Injection | 1563.479 | 491.267 |
| Group | Value (nmol*h/L) | Spread |
|---|---|---|
| Infacort® | 2543.24 | 713.76 |
| Hydrocortisone Tablet | 2896.73 | 850.31 |
| i.v Hydrocortisone Injection | 2923.46 | 971.41 |
| Group | Value (participants) |
|---|---|
| Endogenous Cortisol | 3 |
| Dexamethasone | 3 |
| Infacort® | 0 |
| Hydrocortisone Tablet | 1 |
| i.v Hydrocortisone Injection | 2 |
| Group | Value (ug/mL) | Spread |
|---|---|---|
| Endogenous Cortisol | 22.950 | 2.7355 |
| Dexamethasone | 23.441 | 3.0381 |
| Infacort® | 22.386 | 2.8753 |
| Hydrocortisone Tablet | 21.757 | 3.6545 |
| i.v Hydrocortisone Injection | 21.482 | 3.2047 |
| Group | Value (uIU/mL) | Spread |
|---|---|---|
| Endogenous Cortisol | 70.529 | 17.975 |
| Dexamethasone | 80.668 | 40.801 |
| Infacort® | 77.575 | 32.195 |
| Hydrocortisone Tablet | 70.650 | 34.983 |
| i.v Hydrocortisone Injection | 70.121 | 27.140 |
| Group | Value (nmol/L) | Spread |
|---|---|---|
| Endogenous Cortisol | 447.355 | 77.005 |
| Dexamethasone | 19.349 | 9.567 |
| Infacort® | 963.134 | 283.376 |
| Hydrocortisone Tablet | 893.077 | 259.730 |
| i.v Hydrocortisone Injection | 1580.337 | 492.285 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Endogenous CortisolNo 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. | – | 0 / 14 | 3 / 14 |
| Dexamethasone1mg 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 | – | 0 / 14 | 3 / 14 |
| Infacort®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. Infacort | – | 0 / 14 | 0 / 14 |
| Hydrocortisone Tablet20mg 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. Hydrocortisone Tablet | – | 0 / 14 | 1 / 14 |
| i.v Hydrocortisone Injection20mg 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. i.v. Hydrocortisone Injection | – | 0 / 14 | 2 / 14 |
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