NCT03311932

A Study of Infacort® Versus Cortef® in Healthy Adult Male and Female Subjects

A Two-part, Single Centre, Open-label, Randomised, Single Dose, Two-period, Crossover, Relative Bioavailability Study of Infacort® Versus Cortef® in Dexamethasone-suppressed Healthy Adult Male and Female Subjects in the Fasted and Fed States.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Neurocrine UK Limited · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This was a two-part, single centre, open-label, randomised, single dose, two-period, crossover study to evaluate the bioavailability of Infacort® versus Cortef® immediate release hydrocortisone tablets in dexamethasone-suppressed healthy adult male and female subjects in the fasted and fed states.

Detailed description

The study was conducted in two parts (Part 1 and 2) which were not performed sequentially. In Part 1, 26 subjects were dosed in a fasted condition and in Part 2, 25 subjects were dosed in a fed condition. Each part comprised of a pre-study screen, followed by 2 treatment periods (1 and 2) and a post-study follow-up. Screening assessments (for Parts 1 and 2) were conducted within the 28 days before the first administration of a study intervention. Eligible participants were asked to return for the 2 treatment periods. Continued eligibility was confirmed pre-dose for each treatment period. Part 1 (fasted state): Treatment Periods: Eligible participants received a single dose of each study intervention over 2 treatment periods (1 per treatment period). Each treatment period was approximately 1.5 days in duration. Participants arrived at the Clinical Unit on Day -1 and dexamethasone 1 mg was administrated at approximately 22:00 hours and then again at approximately 06:00 and 12:00 of Day 0 of each treatment period to suppress endogenous cortisol production. The study intervention was administered at approximately 08:00 on Day 0 in the fasted state (after an overnight fast of at least 10 hours). Participants were discharged following the 12-hour post-dose blood sampling and consumption of a snack (Day 0). Part 2 (fed state): The same procedures were followed as for Part 1 except that study interventions were administered in a fed condition (30 minutes after the start of a standardised high-fat breakfast). PK samples in both study parts were collected pre-dose and up to 12 hours post-dose (19 samples for each treatment period) for measurement of cortisol levels. Safety was evaluated throughout the study. There was at least a 7-day washout period (up to a maximum of 14 days) between dose administrations. After completion of both study periods, participants were to return 7±2 days later for a final follow-up visit.

Conditions

• Adrenal Insufficiency

Interventions

Type	Name	Description
DRUG	Infacort®	Immediate release multiparticulate formulation (granules) of hydrocortisone
DRUG	Cortef®	Immediate release hydrocortisone tablets

Timeline

• Start date: 2018-04-16
• Primary completion: 2018-07-13
• Completion: 2018-07-13
• First posted: 2017-10-17
• Last updated: 2019-10-29

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study