NCT03178214 is a Phase 1 clinical trial of Infacort in Adrenal Insufficiency, sponsored by Neurocrine UK Limited.

Who is sponsoring NCT03178214?

NCT03178214 is sponsored by Neurocrine UK Limited.

What drugs are being tested in NCT03178214?

Interventions in NCT03178214: Infacort.

What condition does NCT03178214 study?

NCT03178214 studies Adrenal Insufficiency.

Is NCT03178214 still recruiting?

NCT03178214 is currently completed. Last updated 9 November 2017.

Last reviewed 2017-11-09 · How we verify

NCT03178214

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Last updated 9 November 2017

What this trial tests

Phase 1 trial testing Infacort in Adrenal Insufficiency in 19 participants. Completed in 26 July 2017.

Timeline

22 May 2017

Primary endpoint
26 July 2017

26 July 2017

Quick facts

Lead sponsor	Neurocrine UK Limited
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	19
Start date	22 May 2017
Primary completion	26 July 2017
Estimated completion	26 July 2017
Sites	1 location across United Kingdom

Drugs / interventions tested

Infacort

Conditions studied

Adrenal Insufficiency — all drugs for Adrenal Insufficiency →

Sponsor

Neurocrine UK Limited — full company profile →

Who can join

Adults 18 to 45, male only, with Adrenal Insufficiency. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Hydrocortisone Granules Are Bioequivalent When Sprinkled Onto Food or Given Directly on the Tongue.
Daniel E, Digweed D, Quirke J, Voet B, et al · · 2019 · cited 6× · PMID 30993254 · DOI 10.1210/js.2018-00380
Abstracts des Kongresses für Kinder- und Jugendmedizin 2019
· 2019

Verify or expand the search:

Other recruiting trials for Adrenal Insufficiency

Currently open trials in the same condition.

NCT07168122 — Establishment and Clinical Application of Reference Intervals of Salivary Cortisol · recruiting
NCT06955286 — Study on the Incidence of Adrenal Insufficiency After Surgery in Primary Aldosteronism Patients Concurrent With or Witho · recruiting
NCT06861530 — A Swiss Assessment of Hypothalamic-pituitary-adrenal Axis Suppression After Glucocorticoid Therapy for Leukemia and Lymp · recruiting
NCT05435781 — Effect of Supplemental Hydrocortisone During Stress in Prednisolone-induced Adrenal Insufficiency · Phase 4 · recruiting
NCT05149638 — Updated Diagnostic Cortisol Values for Adrenal Insufficiency · NA · recruiting

Other Neurocrine UK Limited trials

Trials by the same sponsor.

NCT05063994 — Comparison of Chronocort Versus Standard Hydrocortisone Replacement Therapy in Participants Aged 16 Years and Over With · Phase 3 · completed
NCT05299554 — Long-term Safety Study of Chronocort in the Treatment of Participants With Congenital Adrenal Hyperplasia · Phase 3 · completed
NCT05222152 — Chronocort Versus Plenadren Replacement Therapy in Adults With Adrenal Insufficiency · Phase 2 · completed
NCT03532022 — Open-label Comparison of Chronocort® Versus Standard Glucocorticoid Replacement Therapy · Phase 3 · withdrawn
NCT03311932 — A Study of Infacort® Versus Cortef® in Healthy Adult Male and Female Subjects · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03178214 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Neurocrine UK Limited
Last refreshed: 9 November 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03178214.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing