Adrenal InsufficiencyPhase 1NCT01960530

An Investigational Study of Hydrocortisone

A Phase 1 study testing Hydrocortisone granules, Hydrocortisone Tablet and i.v. Hydrocortisone Injection in people with Adrenal Insufficiency, run by Neurocrine UK Limited at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 60 years, men onlyHealthy volunteers can take part
Conditions the study is for: Adrenal Insufficiency
What is being tested?: Hydrocortisone granules, Hydrocortisone Tablet and i.v. Hydrocortisone Injection
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: 1 siteUnited Kingdom
Study dates: Oct 2013to Nov 2014
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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.

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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.

Who cannot join

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.

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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).

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Simbec Research Limited
Merthyr Tydfil, CF48 4DR

Other trials in United Kingdom

About this study

Official title: An Open Label, Partially Randomised, Single Dose, Crossover Study to Evaluate the PK, Oral Bioavailability and Relationship to Metabolic Parameters of Hydrocortisone and Infacort® in Healthy Adult Male Volunteers.

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: Adrenal Insufficiency
Being tested: Hydrocortisone granules, Hydrocortisone Tablet, i.v. Hydrocortisone Injection, Dexamethasone
Medical subject headings: Adrenal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Hydrocortisone granulesDrug
Also called Infacort
Multi-particulate granules
Hydrocortisone TabletDrug
Also called Commerical supply
Standard hydrocortisone tablets
i.v. Hydrocortisone InjectionDrug
Also called Commerical supply
Standard hydrocortisone solution for intravenous injection
DexamethasoneOther
Also called Non-IMP
Challenge agent

Study groups in NCT01960530
Study group	Role	What they receive
Endogenous Cortisol	No intervention	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.
Dexamethasone	Other	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 Receives: Other: Dexamethasone
Infacort®	Experimental	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. Receives: Drug: Hydrocortisone granules
Hydrocortisone Tablet	Active comparator	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. Receives: Drug: Hydrocortisone Tablet
i.v Hydrocortisone Injection	Active comparator	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. Receives: Drug: i.v. Hydrocortisone Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (4)

Adverse Events (AEs)
Number of subjects with adverse events throughout the study.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Blood, urine & saliva samples on Day 1 and/or Day 2 of each Study Period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2013Nov 2014

First posted10 Oct 2013 (estimated)
Study startOct 2013
Primary completionNov 2014
Study completionNov 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Adrenal InsufficiencyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01960530
Sponsor's protocol ID: Infacort 002
Status last verified: Sep 2026
First submitted: 6 Oct 2013
Last updated: 2 Oct 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Adrenal Insufficiency trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Label, Partially Randomised, Single Dose, Crossover Study to Evaluate the PK, Oral Bioavailability and Relationship to Metabolic Parameters of Hydrocortisone and Infacort® in Healthy Adult Male Volunteers.
ClinicalTrials.gov ID: NCT01960530
Acronym / sponsor ID: Infacort 002
Conditions: Adrenal Insufficiency
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: Neurocrine UK LimitedIndustry (pharma, biotech, devices)
Collaborators: Simbec Research
Study start: Oct 2013
Primary completion: Nov 2014 (actual)
Study completion: Nov 2014 (actual)
First posted: 10 Oct 2013 (estimated)
Results: Posted 13 Apr 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
Endogenous Cortisol	No intervention	–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.
Dexamethasone	Other	Other: Dexamethasone1mg 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
Infacort®	Experimental	Drug: Hydrocortisone granules20mg 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.
Hydrocortisone Tablet	Active comparator	Drug: Hydrocortisone Tablet20mg 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.
i.v Hydrocortisone Injection	Active comparator	Drug: i.v. Hydrocortisone Injection20mg 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.

Who may qualify

Ages: 18 to 60 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (14 listed)

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.

Key exclusion criteria (15 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Hydrocortisone granulesAlso: InfacortMulti-particulate granules	Drug	Infacort®
Hydrocortisone TabletAlso: Commerical supplyStandard hydrocortisone tablets	Drug	Hydrocortisone Tablet
i.v. Hydrocortisone InjectionAlso: Commerical supplyStandard hydrocortisone solution for intravenous injection	Drug	i.v Hydrocortisone Injection
DexamethasoneAlso: Non-IMPChallenge agent	Other	Dexamethasone

Primary outcome

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

4 secondary outcomes

Adverse Events (AEs)
Time frame: Days 1-2 during each Study Period
Concentrations of Cortisol Binding Protein
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.
Time frame: Blood samples on Day 1 and/or Day 2 of each Study Period
PK and Metabolism of Cortisol
Time frame: Blood, urine & saliva samples on Day 1 and/or Day 2 of each Study Period

Results and safety

Results posted to the registry on 13 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
5-period Crossover	14	14

Primary outcome: Maximum Serum Concentration (Cmax)

Time frame: Hourly from 0 to 24 hours. Geometric mean (Standard Deviation). Unit: nmol/L

Measure	Infacort® n = 14	Hydrocortisone Tablet n = 14	i.v Hydrocortisone Injection n = 14
Value	940.012 (283.773)	896.489 (258.083)	1563.479 (491.267)

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)

Population analysed: All randomised subjects who received no IMP (no treatment), dexamethasone, oral Infacort®, hydrocortisone tablet and i.v. hydrocortisone, had sufficient serum cortisol concentration by time profiles and who did not violate the protocol

Primary outcome: AUC0-t

Time frame: Hourly from 0 to 24 hours. Geometric mean (Standard Deviation). Unit: nmol*h/L

Measure	Infacort® n = 14	Hydrocortisone Tablet n = 13	i.v Hydrocortisone Injection n = 14
Value	2543.24 (713.76)	2896.73 (850.31)	2923.46 (971.41)

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)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 8 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Endogenous Cortisol	0 of 14 (0%)	3 of 14 (21.4%)	Not reported
Dexamethasone	0 of 14 (0%)	3 of 14 (21.4%)	Not reported
Infacort®	0 of 14 (0%)	0 of 14 (0%)	Not reported
Hydrocortisone Tablet	0 of 14 (0%)	1 of 14 (7.1%)	Not reported
i.v Hydrocortisone Injection	0 of 14 (0%)	2 of 14 (14.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Adrenal Insufficiency

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RecruitingObservational study
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RecruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Girish Sharma principal investigator

Simbec Research

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Serum Concentration (Cmax) (time frame: Hourly from 0 to 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01960530.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.