NCT02777268

Comparison of Pharmacokinetics of Infacort® Versus Immediate-release Hydrocortisone

A Single Centre, Open Label, Randomised, Crossover Study in Dexamethasone-suppressed Healthy Adult Male Volunteers to Compare the Pharmacokinetics of Infacort® Versus Immediate-release Hydrocortisone Tablets at a Single Dose of 10 mg and to Evaluate the Dose Proportionality of Infacort® at Doses of 0.5 mg, 2 mg, 5 mg and 10 mg

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Neurocrine UK Limited · Industry
• Sex: Male
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This was a single centre, open-label, randomised, 5-way crossover study.

Detailed description

This was a single centre, open-label, randomised, 5-way crossover study design to compare the PK of Infacort® versus immediate-release hydrocortisone tablets and to evaluate the dose proportionality of 0.5 mg, 2 mg, 5 mg and 10 mg Infacort®. The study was conducted in 1 cohort of 16 healthy male subjects and comprised a Screening Visit, 5 treatment periods (Treatment Periods 1 to 5) and a Post-study Visit.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Infacort	Multi-particulate granules
DRUG	Hydrocortisone	Tablet

Timeline

• Start date: 2013-07-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2016-05-19
• Last updated: 2017-12-02
• Results posted: 2017-08-10