NCT03343327

A Study of Chronocort® Versus Cortef ® in Healthy Adult Male Subjects

A Single Centre, Open-label, Randomised, Single Dose, Two Period, Crossover Relative Bioavailability Study of Chronocort® Versus Cortef® Immediate Release Hydrocortisone Tablets in Dexamethasone-suppressed Healthy Adult Male Subjects.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Neurocrine UK Limited · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This was a single centre, open label, randomised, two period, crossover study to evaluate the bioavailability of Chronocort® versus Cortef® immediate release hydrocortisone tablets in dexamethasone-suppressed healthy adult male subjects.

Detailed description

This study was an open-label, randomised, single dose, two-period, crossover study in 25 healthy male subjects. The study comprised of a pre-study screen, followed by 2 treatment periods (1 and 2) and a post-study followup. Screening (Day -28 to Day -1): Screening assessments were carried out within 28 days before first administration of IMP. Eligible subjects were asked to return for the treatment periods. Continued eligibility was confirmed pre-dose during each treatment period. Treatment Periods (Day -1 to Day 1): Eligible subjects received a single-dose of each IMP over 2 treatment periods (1/period as determined by the randomisation schedule), each separated by 7 days washout. Each study period was approximately 2 days in duration, from the afternoon of Day -1 to the morning of Day 1 at 24 hours (h) post-dose. During each treatment period, Subjects arrived at the Clinical Unit on Day -1, IMP was administered on the morning of Day 0 fasted (following an overnight fast of at least 10 h) and subjects were discharged following the 24 h post-dose blood samples and completion of the scheduled measurements. Pharmacokinetic (PK) samples were collected pre-dose at \~ -2min and up to 23 h post-dose (Day 1) (24 samples) for the measurement of cortisol. A further 3 baseline samples were taken for the measurement of cortisol. Safety was also evaluated throughout the study. Post Study: After completion of both study periods, the subjects returned 4-22 days later for the final followup visit.

Conditions

• Adrenal Insufficiency

Interventions

Type	Name	Description
DRUG	Chronocort®	Single dose of 20mg Chronocort® administered in one treatment period
DRUG	Cortef®	Single dose of 20mg Cortef® administered in one treatment period

Timeline

• Start date: 2018-02-19
• Primary completion: 2018-04-20
• Completion: 2018-04-20
• First posted: 2017-11-17
• Last updated: 2020-06-19

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study