MedTrace Logo

An Investigational Study of Hydrocortisone

NCT01960530 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2022-04-26

Study results available
· View outcomes & findings →

Summary

This study will investigate a new drug called Infacort®; a newly-developed immediate release formulation of a well-established drug called hydrocortisone. Hydrocortisone is used as a replacement treatment for people whose adrenal glands are not producing enough natural cortisol - a condition known as adrenal insufficiency. The study will assess how Infacort® acts once inside the body, by measuring cortisol and other hormone levels in the body, compared to already marketed hydrocortisone tablet and hydrocortisone intravenous (through the vein) injection.

The population who are eligible to take part in the study are healthy male volunteers, aged between 18 and 60 years of age.

Conditions

Interventions

DRUG

Hydrocortisone granules

Multi-particulate granules

DRUG

Hydrocortisone Tablet

Standard hydrocortisone tablets

DRUG

i.v. Hydrocortisone Injection

Standard hydrocortisone solution for intravenous injection

OTHER

Dexamethasone

Challenge agent

Sponsors & Collaborators

  • Simbec Research

    collaborator INDUSTRY

  • Neurocrine UK Limited

    lead INDUSTRY

Principal Investigators

  • Girish Sharma · Simbec Research

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2014-11-30
Completion
2014-11-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01960530 on ClinicalTrials.gov