Ignite Creation Date:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2026-02-25 @ 4:58 PM
Study NCT ID:
NCT02777268
Status:
COMPLETED
Last Update Posted:
2017-12-02
First Post:
2016-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of Pharmacokinetics of Infacort® Versus Immediate-release Hydrocortisone
Sponsor:
Neurocrine UK Limited
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: