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.
The study will evaluate the normal physiology, PK and metabolism of cortisol, investigate the PK and bioavailability of cortisol from the test Infacort® Granules (hydrocortisone) and the reference hydrocortisone tablets and i.v injection in healthy adult male volunteers and explore the role of cortisol in the regulation of metabolic pathways.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
14
Multi-particulate granules
Standard hydrocortisone tablets
Standard hydrocortisone solution for intravenous injection
Challenge agent
Simbec Research Limited
Merthyr Tydfil, United Kingdom
Maximum Serum Concentration (Cmax)
Derived PK for Serum Cortisol: Maximum serum concentration (Cmax)
Time frame: Hourly from 0 to 24 hours
AUC0-t
Derived PK for Serum Cortisol: Area under the curve from 0-24 hours
Time frame: Hourly from 0 to 24 hours
Adverse Events (AEs)
Number of subjects with adverse events throughout the study.
Time frame: Days 1-2 during each Study Period
Concentrations of Cortisol Binding Protein
Cortisol protein binding under physiological conditions and after the administration of dexamethasone and hydrocortisone.
Time frame: Blood samples on Day 1 and/or Day 2 of each Study Period
Insulin Sensitivity Under Physiological Conditions and After Administration of Dexamethasone and Infacort®, Hydrocortisone Tablets and i.v Hydrocortisone.
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.
Time frame: Blood samples on Day 1 and/or Day 2 of each Study Period
PK and Metabolism of Cortisol
Blood: Serum cortisol under physiological conditions and after administration of dexamethasone and Infacort® Granules, Hydrocortisone Tablets and i.v Hydrocortisone Injection.
Time frame: Blood, urine & saliva samples on Day 1 and/or Day 2 of each Study Period
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