NCT01960530

An Investigational Study of Hydrocortisone

An Open Label, Partially Randomised, Single Dose, Crossover Study to Evaluate the PK, Oral Bioavailability and Relationship to Metabolic Parameters of Hydrocortisone and Infacort® in Healthy Adult Male Volunteers.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Neurocrine UK Limited · Industry
• Sex: Male
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Adrenal Insufficiency

Interventions

Type	Name	Description
DRUG	Hydrocortisone granules	Multi-particulate granules
DRUG	Hydrocortisone Tablet	Standard hydrocortisone tablets
DRUG	i.v. Hydrocortisone Injection	Standard hydrocortisone solution for intravenous injection
OTHER	Dexamethasone	Challenge agent

Timeline

• Start date: 2013-10-01
• Primary completion: 2014-11-01
• Completion: 2014-11-01
• First posted: 2013-10-10
• Last updated: 2022-04-26
• Results posted: 2017-04-13

Locations

1 site across 1 country: United Kingdom