NCT03178214

Bioavailability of Infacort When Administered Onto Food Compared to Direct Oral Administration

A Single Centre, Open-label, Randomised, Single Dose, Three-period, Crossover Study to Evaluate the Bioavailability of Infacort Administered as Sprinkles With Soft Food and Yoghurt Compared With Direct Administration to the Back of the Tongue in Dexamethasone-suppressed Healthy Adult Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Neurocrine UK Limited · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a single centre, open-label, randomised, single dose, three-period, crossover study to evaluate the bioavailability of Infacort® administered as 'sprinkles' with soft food and yoghurt compared with direct administration to the back of the tongue in dexamethasone-suppressed healthy adult male subjects. The study will comprise of a pre-study screen, followed by 3 treatment periods and a post-study follow-up.

Conditions

• Adrenal Insufficiency

Interventions

Type	Name	Description
DRUG	Infacort	Immediate-release multiparticulate formulation of hydrocortisone.

Timeline

• Start date: 2017-05-22
• Primary completion: 2017-07-26
• Completion: 2017-07-26
• First posted: 2017-06-06
• Last updated: 2017-11-09

Locations

1 site across 1 country: United Kingdom