CompletedNCT01960530Updated Oct 2, 2026Results posted

An Investigational Study of Hydrocortisone

A Phase 1 interventional study of Hydrocortisone granules and Hydrocortisone Tablet in Adrenal Insufficiency, sponsored by Neurocrine UK Limited. Completed at 1 site in United Kingdom. Open to male participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-02.

Sponsored by Neurocrine UK Limited · Phase 1, Interventional, and Other

Phase: Phase 1
Study type: Interventional
Enrollment: 14
Allocation: Randomized
Ages: 18 Years to 60 Years
Sex: Male

Study 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.

Read the detailed description

The study will evaluate the normal physiology, PK and metabolism of cortisol, investigate the PK and bioavailability of cortisol from the test Infacort® Granules (hydrocortisone) and the reference hydrocortisone tablets and i.v injection in healthy adult male volunteers and explore the role of cortisol in the regulation of metabolic pathways.

Conditions studied

Adrenal Insufficiency

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Adrenal Insufficiency 132

In context

Adrenal Insufficiency

132 studies on the registry are indexed under Adrenal Insufficiency; 26 are open to participants now.

This study's enrollment of 14 is below the median of 37 across 70 interventional studies indexed under Adrenal Insufficiency.

Browse Adrenal Insufficiency studies →

Lead sponsor

Neurocrine UK Limited is the lead sponsor of 18 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 60 Years
Sexes eligible: Male
Accepts healthy volunteers: Yes

Inclusion criteria

Healthy male volunteers between 18 and 60 years of age, inclusive (at screening).
Subjects with a Body Mass Index (BMI) of 21-28. Body Mass Index = Body weight (kg) / (Height (m))*2.
Subjects with no clinically significant abnormal serum biochemistry, haematology and urinalysis values within 14 days prior to Day 1 of Study Period 1.
Subjects with a negative urinary drugs of abuse screen, determined within 14 days prior to Day 1 of Study Period 1. A positive alcohol test may be repeated at the discretion of the Investigator.
Subjects with negative HIV and Hepatitis B and C results.
Subjects with no clinically significant abnormalities in 12-lead electrocardiogram (ECG) determined within 14 days prior to Day 1 of Study Period 1.
Subjects with no clinically-significant deviation outside the normal ranges for blood pressure and pulse measurements.
Subjects (unless anatomically sterile or where abstaining from sexual intercourse is in line with the preferred and usual lifestyle of the subject) and sexual partners must use effective contraception methods during the trial and for 3 months after the last dose, for example:
- Oral contraceptive + condom
- Intra-uterine device (IUD) + condom
- Diaphragm with spermicide + condom
Subjects must be available to complete the study.
Subjects must satisfy a medical examiner about their fitness to participate in the study.
Subjects must provide written informed consent to participate in the study.

Exclusion criteria

Exclusion Criteria:

A clinically significant history of gastrointestinal disorder likely to influence drug absorption.
Receipt of regular medication within 14 days prior to Day 1 of Study Period 1 (including high dose vitamins, dietary supplements or herbal remedies).
Receipt of any vaccination within 14 days prior to Day 1 of Study Period 1.
Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction.
Presence of clinically significant infections (systemic fungal and viral infections, acute bacterial infections).
Current or previous history of tuberculosis.
A clinically significant history of previous allergy / sensitivity to Hydrocortisone and/or Dexamethasone.
A clinically significant history or family history of psychiatric disorders/illnesses.
A clinically significant history of drug or alcohol abuse.
Inability to communicate well with the Investigator (i.e., language problem, poor mental development or impaired cerebral function).
Participation in a New Chemical Entity clinical study within the previous 4 months or a marketed drug clinical study within the previous 3 months. (N.B. The washout period between trials is defined as the period of time elapsed between the last dose of the previous study and the first dose of the next study)
Subjects who have consumed more than 2 units of alcohol per day within seven (7) days prior to Day 1 of Study Period 1or have consumed any alcohol within the 48 hour period prior to Day 1 of Study Period 1.
Donation of 450ml or more of blood within the previous 3 months.
Subjects who smoke (or ex-smokers who have smoked within 6 months prior to Day 1 of Study Period 1).
Subjects who work shifts (i.e. regularly alternate between days, afternoons and nights).

Study design

Phase: Phase 1
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 14 participants (actual)

Study arms

No intervention
Endogenous Cortisol
No Study medication will be given during this study period, however various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.
Other
Dexamethasone
1mg Dexamethasone will be administered at 22:00 on Day 1 and at 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points. Dexamethasone is considered a challenge agent and therefore a non-IMP
Other: Dexamethasone
Experimental
Infacort®
20mg Infacort® will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous adrenocorticotropic Hormone (ACTH) and cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.
Drug: Hydrocortisone granules
Active comparator
Hydrocortisone Tablet
20mg Hydrocortisone Tablet will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous ACTH and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.
Drug: Hydrocortisone Tablet
Active comparator
i.v Hydrocortisone Injection
20mg i.v. Hydrocortisone Injection will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous ACTH and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.
Drug: i.v. Hydrocortisone Injection

Interventions

DrugHydrocortisone granules
Multi-particulate granules
Also known as: Infacort
DrugHydrocortisone Tablet
Standard hydrocortisone tablets
Also known as: Commerical supply
Drugi.v. Hydrocortisone Injection
Standard hydrocortisone solution for intravenous injection
Also known as: Commerical supply
OtherDexamethasone
Challenge agent
Also known as: Non-IMP

What researchers measure

Primary outcomes

Maximum Serum Concentration (Cmax)
Derived PK for Serum Cortisol: Maximum serum concentration (Cmax)
Time frame: Hourly from 0 to 24 hours
AUC0-t
Derived PK for Serum Cortisol: Area under the curve from 0-24 hours
Time frame: Hourly from 0 to 24 hours

Secondary outcomes

Adverse Events (AEs)
Number of subjects with adverse events throughout the study.
Time frame: Days 1-2 during each Study Period
Concentrations of Cortisol Binding Protein
Cortisol protein binding under physiological conditions and after the administration of dexamethasone and hydrocortisone.
Time frame: Blood samples on Day 1 and/or Day 2 of each Study Period
Insulin Sensitivity Under Physiological Conditions and After Administration of Dexamethasone and Infacort®, Hydrocortisone Tablets and i.v Hydrocortisone.
A standardised mixed meal elevates blood glucose and provides a reproducible stimulation of insulin release. Lower levels of insulin secretion, whilst maintaining normoglycaemia would indicate enhanced insulin sensitivity and glucose disposal; higher insulin levels will reflect insulin resistance.
Time frame: Blood samples on Day 1 and/or Day 2 of each Study Period
PK and Metabolism of Cortisol
Blood: Serum cortisol under physiological conditions and after administration of dexamethasone and Infacort® Granules, Hydrocortisone Tablets and i.v Hydrocortisone Injection.
Time frame: Blood, urine & saliva samples on Day 1 and/or Day 2 of each Study Period

Results

Posted Apr 13, 2017

Participant flow

Participant flow — Overall Study
Milestone	5-period Crossover
Started	14
Completed	14
Not completed	0

Outcome measures

PrimaryMaximum Serum Concentration (Cmax)

Derived PK for Serum Cortisol: Maximum serum concentration (Cmax)

Time frame:: Hourly from 0 to 24 hours
Reported as:: Geometric mean · nmol/L

Maximum Serum Concentration (Cmax)
nmol/L	Infacort®	Hydrocortisone Tablet	i.v Hydrocortisone Injection
Maximum Serum Concentration (Cmax)	940.012 ± 283.773	896.489 ± 258.083	1563.479 ± 491.267

Statistical analysis

Infacort® vs i.v Hydrocortisone Injection · Geometric lsmean ratio: 60.12 · 90% CI 54.69 to 66.10
Infacort® vs Hydrocortisone Tablet · Geometric lsmean ratio: 106.83 · 90% CI 96.92 to 117.76

SecondaryAdverse Events (AEs)

Number of subjects with adverse events throughout the study.

Time frame:: Days 1-2 during each Study Period
Reported as:: Number · participants

Adverse Events (AEs)
participants	Endogenous Cortisol	Dexamethasone	Infacort®	Hydrocortisone Tablet	i.v Hydrocortisone Injection
Adverse Events (AEs)	3	3	0	1	2

SecondaryConcentrations of Cortisol Binding Protein

Cortisol protein binding under physiological conditions and after the administration of dexamethasone and hydrocortisone.

Time frame:: Blood samples on Day 1 and/or Day 2 of each Study Period
Reported as:: Mean · ug/mL

Concentrations of Cortisol Binding Protein
ug/mL	Endogenous Cortisol	Dexamethasone	Infacort®	Hydrocortisone Tablet	i.v Hydrocortisone Injection
Concentrations of Cortisol Binding Protein	22.950 ± 2.7355	23.441 ± 3.0381	22.386 ± 2.8753	21.757 ± 3.6545	21.482 ± 3.2047

SecondaryInsulin Sensitivity Under Physiological Conditions and After Administration of Dexamethasone and Infacort®, Hydrocortisone Tablets and i.v Hydrocortisone.

A standardised mixed meal elevates blood glucose and provides a reproducible stimulation of insulin release. Lower levels of insulin secretion, whilst maintaining normoglycaemia would indicate enhanced insulin sensitivity and glucose disposal; higher insulin levels will reflect insulin resistance.

Time frame:: Blood samples on Day 1 and/or Day 2 of each Study Period
Reported as:: Mean · uIU/mL

Insulin Sensitivity Under Physiological Conditions and After Administration of Dexamethasone and Infacort®, Hydrocortisone Tablets and i.v Hydrocortisone.
uIU/mL	Endogenous Cortisol	Dexamethasone	Infacort®	Hydrocortisone Tablet	i.v Hydrocortisone Injection
Insulin Sensitivity Under Physiological Conditions and After Administration of Dexamethasone and Infacort®, Hydrocortisone Tablets and i.v Hydrocortisone.	70.529 ± 17.975	80.668 ± 40.801	77.575 ± 32.195	70.650 ± 34.983	70.121 ± 27.140

SecondaryPK and Metabolism of Cortisol

Blood: Serum cortisol under physiological conditions and after administration of dexamethasone and Infacort® Granules, Hydrocortisone Tablets and i.v Hydrocortisone Injection.

Time frame:: Blood, urine & saliva samples on Day 1 and/or Day 2 of each Study Period
Reported as:: Mean · nmol/L

PK and Metabolism of Cortisol
nmol/L	Endogenous Cortisol	Dexamethasone	Infacort®	Hydrocortisone Tablet	i.v Hydrocortisone Injection
PK and Metabolism of Cortisol	447.355 ± 77.005	19.349 ± 9.567	963.134 ± 283.376	893.077 ± 259.730	1580.337 ± 492.285

PrimaryAUC0-t

Derived PK for Serum Cortisol: Area under the curve from 0-24 hours

Time frame:: Hourly from 0 to 24 hours
Reported as:: Geometric mean · nmol*h/L

AUC0-t
nmol*h/L	Infacort®	Hydrocortisone Tablet	i.v Hydrocortisone Injection
AUC0-t	2543.24 ± 713.76	2896.73 ± 850.31	2923.46 ± 971.41

Statistical analysis

Infacort® vs i.v Hydrocortisone Injection · Mean difference (final values): 86.99 · 90% CI 79.23 to 95.52
Infacort® vs Hydrocortisone Tablet · Mean difference (final values): 89.96 · 90% CI 81.72 to 99.04

Adverse events

Collected over 8 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Endogenous Cortisol	—	0/14 (0%)	3/14 (21.4%)
Dexamethasone	—	0/14 (0%)	3/14 (21.4%)
Infacort®	—	0/14 (0%)	0/14 (0%)
Hydrocortisone Tablet	—	0/14 (0%)	1/14 (7.1%)
i.v Hydrocortisone Injection	—	0/14 (0%)	2/14 (14.3%)

Most frequent other events

Most frequent other events
Event	Endogenous Cortisol	Dexamethasone	Infacort®	Hydrocortisone Tablet	i.v Hydrocortisone Injection
FatigueGeneral disorders	0/14	0/14	0/14	0/14	1/14
PyrexiaGeneral disorders	1/14	0/14	0/14	0/14	0/14
Vision blurredEye disorders	0/14	1/14	0/14	0/14	0/14
DyspepsiaGastrointestinal disorders	0/14	0/14	0/14	1/14	0/14
NasopharyngitisInfections and infestations	1/14	1/14	0/14	0/14	0/14
HeadacheNervous system disorders	1/14	1/14	0/14	0/14	0/14
Mood swingsPsychiatric disorders	0/14	0/14	0/14	0/14	1/14

Baseline characteristics

Healthy volunteers

Age, Categorical
Age, Categorical(Participants)	All Participants
<=18 years	0
Between 18 and 65 years	14
>=65 years	0

Age, Continuous
Age, Continuous(years)	All Participants
Mean	32.9 ± 11.66

Sex: Female, Male
Sex: Female, Male(Participants)	All Participants
Female	0
Male	14

Region of Enrollment
Region of Enrollment(participants)	All Participants
United Kingdom	14

Study locations

1 site

Simbec Research Limited
Merthyr Tydfil, CF48 4DR, United Kingdom

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

1 registry update since Sep 25, 2026

Minor edits

Nothing that changes what the study is or who can join. Edited: verification date and index terms

1 update, last Oct 2, 2026

Show all 1 update

Oct 2, 2026
Minor edits only
+ 2 other changes: verification date and index terms

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01960530
Lead sponsor: Neurocrine UK Limited
Collaborators: Simbec Research
Responsible party: Sponsor
First posted: Oct 10, 2013
Start date: Oct 2013
Primary completion: Nov 2014
Completion: Nov 2014
Results posted: Apr 13, 2017
Last update: Oct 2, 2026

Study contacts

Girish Sharma

principal investigator · Simbec Research

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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