Healthy SubjectsPhase 1NCT02777268

Comparison of Pharmacokinetics of Infacort® Versus Immediate-release Hydrocortisone

A Phase 1 study testing Infacort and Hydrocortisone in people with Healthy Subjects, run by Neurocrine UK Limited.

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

This was a single centre, open-label, randomised, 5-way crossover study. Read more about this study

Who is it for?: Ages 18 to 60 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy Subjects
What is being tested?: Infacort and Hydrocortisone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: No sites listed yet
Study dates: Jul 2013to Sep 2013
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 Visit).
Subjects with a Body Mass Index (BMI) of 21-28.
Subjects with no clinically significant abnormal serum biochemistry, haematology and urine examination values within 14 days prior to the first dose of investigational medicinal product (IMP).
Subjects with a negative urinary drugs of abuse screen determined within 14 days prior to the first dose of IMP. A positive alcohol test may have been repeated at the discretion of the Investigator.
Subjects with negative human immunodeficiency virus (HIV) and hepatitis B surface antigen (Hep B) and hepatitis C virus antibody (Hep C) results.
Subjects with no clinically significant abnormalities in 12-lead electrocardiogram (ECG) determined within 14 days prior to the first dose of IMP.

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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 was in-line with the preferred and usual lifestyle of the subject) and sexual partners used effective contraception methods during the trial and for 3 months after the last dose of IMP, for example; oral contraceptive + condom, intra-uterine device (IUD) + condom or diaphragm with spermicide + condom.
Subjects were available to complete the study.
Subjects satisfied a medical examiner about their fitness to participate in the study.
Subjects provided 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 the first dose of IMP (including high dose vitamins, dietary supplements or herbal remedies).
Receipt of any vaccination within 14 days prior to the first dose of IMP.
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).
Participated 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 was 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 had consumed more than 2 units of alcohol per day within 7 days prior to the first dose of IMP or had consumed any alcohol within the 48 hr period prior to the first dose of IMP.
Donation of 450 mL or more of blood within the previous 3 months.
Subjects who smoked (or ex-smokers who had smoked within 6 months prior to first dose of IMP).
Subjects who worked shifts (i.e. regularly alternated between days, afternoons and nights).

About this study

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

This was a single centre, open-label, randomised, 5-way crossover study.

Read the 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.

Conditions: Healthy Subjects
Being tested: Infacort, Hydrocortisone

What participants receive

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

InfacortDrug
Multi-particulate granules
HydrocortisoneDrug
Tablet

Study groups in NCT02777268
Study group	Role	What they receive
Infacort 0.5 mg	Experimental	Multi-particulate granules from 1 (0.5 mg) capsule Receives: Drug: Infacort
Infacort 2 mg	Experimental	Multi-particulate granules from 1 (2 mg) capsule Receives: Drug: Infacort
Infacort 5 mg	Experimental	Multi-particulate granules from 1 (5 mg) capsule Receives: Drug: Infacort
Infacort 10 mg	Experimental	Multi-particulate granules from 1 (10 mg) capsule Receives: Drug: Infacort
Hydrocortisone	Active comparator	1 (10 mg) tablet Receives: Drug: Hydrocortisone

What is being measured

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

Maximum Plasma Concentration (Cmax) of Infacort vs Hydrocortisone
To compare the Cmax of Infacort® versus immediate-release hydrocortisone in a single dose of 10 mg.
Measured: -1h, -0.5h, 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 6.5h, 7h, 7.5h, 8h, 9h, 10h, 11h, 12h
Time to Reach the Maximum Plasma Concentration (Tmax) of Infacort vs Hydrocortisone
To compare the Tmax of Infacort® versus immediate-release hydrocortisone in a single dose of 10 mg.
Measured: -1h, -0.5h, 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 6.5h, 7h, 7.5h, 8h, 9h, 10h, 11h, 12h
Area Under the Curve (AUC0-t) of Infacort vs Hydrocortisone
To compare the AUC0-t of Infacort® versus immediate-release hydrocortisone in a single dose of 10 mg. AUC0-t represents the total exposure to drug over time, hence the reporting of a single value below.
Measured: -1h, -0.5h, 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 6.5h, 7h, 7.5h, 8h, 9h, 10h, 11h, 12h

Secondary outcomes (4)

Maximum Plasma Concentration (Cmax) of Infacort at Doses of 0.5, 2, 5 and 10 mg
To determine the dose proportionality for Infacort® at doses of 0.5 mg, 2 mg, 5 mg and 10 mg.
Measured: -1h, -0.5h, 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 6.5h, 7h, 7.5h, 8h, 9h, 10h, 11h, 12h
Time to Maximum Plasma Concentration (Tmax) of Infacort at Doses of 0.5, 2, 5 and 10 mg
To determine the dose proportionality for Infacort® at doses of 0.5 mg, 2 mg, 5 mg and 10 mg.
Measured: -1h, -0.5h, 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 6.5h, 7h, 7.5h, 8h, 9h, 10h, 11h, 12h
Area Under the Curve (AUC0-t) of Infacort at Doses of 0.5, 2, 5 and 10 mg
To determine the dose proportionality for Infacort® at doses of 0.5 mg, 2 mg, 5 mg and 10 mg.
Measured: 1 day
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) as Assessed by Medical Dictionary for Regulatory Activities (MedDRA) Dictionary, Version 16.0.
To assess the safety and tolerability of Infacort® throughout the study. For a full list of TEAEs per arm, please refer to the Adverse Events section.
Measured: 1 day

Timeline

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

Jul 2013Sep 2013

First posted19 May 2016 (estimated)
Study startJul 2013
Primary completionSep 2013
Study completionSep 2013

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 Healthy SubjectsStudies 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: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02777268
Sponsor's protocol ID: Infacort 001
Status last verified: Sep 2026
First submitted: 27 Apr 2016
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?

Official record

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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: 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
ClinicalTrials.gov ID: NCT02777268
Acronym / sponsor ID: Infacort 001
Conditions: Healthy Subjects
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Neurocrine UK LimitedIndustry (pharma, biotech, devices)
Collaborators: Simbec Research
Study start: Jul 2013
Primary completion: Sep 2013 (actual)
Study completion: Sep 2013 (actual)
First posted: 19 May 2016 (estimated)
Results: Posted 10 Aug 2017

Clinical summary

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

This was a single centre, open-label, randomised, 5-way crossover study.

Detailed description

Study design

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

Arm	Type	Receives
Infacort 0.5 mg	Experimental	Drug: InfacortMulti-particulate granules from 1 (0.5 mg) capsule
Infacort 2 mg	Experimental	Drug: InfacortMulti-particulate granules from 1 (2 mg) capsule
Infacort 5 mg	Experimental	Drug: InfacortMulti-particulate granules from 1 (5 mg) capsule
Infacort 10 mg	Experimental	Drug: InfacortMulti-particulate granules from 1 (10 mg) capsule
Hydrocortisone	Active comparator	Drug: Hydrocortisone1 (10 mg) tablet

Who may qualify

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

Key inclusion criteria (11 listed)

Healthy male volunteers between 18 and 60 years of age, inclusive (at Screening Visit).
Subjects with a Body Mass Index (BMI) of 21-28.
Subjects with no clinically significant abnormal serum biochemistry, haematology and urine examination values within 14 days prior to the first dose of investigational medicinal product (IMP).
Subjects with a negative urinary drugs of abuse screen determined within 14 days prior to the first dose of IMP. A positive alcohol test may have been repeated at the discretion of the Investigator.
Subjects with negative human immunodeficiency virus (HIV) and hepatitis B surface antigen (Hep B) and hepatitis C virus antibody (Hep 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 the first dose of IMP (including high dose vitamins, dietary supplements or herbal remedies).
Receipt of any vaccination within 14 days prior to the first dose of IMP.
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
InfacortMulti-particulate granules	Drug	Infacort 0.5 mg, Infacort 10 mg, Infacort 2 mg, Infacort 5 mg
HydrocortisoneTablet	Drug	Hydrocortisone

Primary outcome

Maximum Plasma Concentration (Cmax) of Infacort vs Hydrocortisone
Time frame: -1h, -0.5h, 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 6.5h, 7h, 7.5h, 8h, 9h, 10h, 11h, 12h
To compare the Cmax of Infacort® versus immediate-release hydrocortisone in a single dose of 10 mg.
Time to Reach the Maximum Plasma Concentration (Tmax) of Infacort vs Hydrocortisone
Time frame: -1h, -0.5h, 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 6.5h, 7h, 7.5h, 8h, 9h, 10h, 11h, 12h
To compare the Tmax of Infacort® versus immediate-release hydrocortisone in a single dose of 10 mg.
Area Under the Curve (AUC0-t) of Infacort vs Hydrocortisone
Time frame: -1h, -0.5h, 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 6.5h, 7h, 7.5h, 8h, 9h, 10h, 11h, 12h
To compare the AUC0-t of Infacort® versus immediate-release hydrocortisone in a single dose of 10 mg. AUC0-t represents the total exposure to drug over time, hence the reporting of a single value below.

4 secondary outcomes

Maximum Plasma Concentration (Cmax) of Infacort at Doses of 0.5, 2, 5 and 10 mg
Time frame: -1h, -0.5h, 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 6.5h, 7h, 7.5h, 8h, 9h, 10h, 11h, 12h
Time to Maximum Plasma Concentration (Tmax) of Infacort at Doses of 0.5, 2, 5 and 10 mg
Time frame: -1h, -0.5h, 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 6.5h, 7h, 7.5h, 8h, 9h, 10h, 11h, 12h
Area Under the Curve (AUC0-t) of Infacort at Doses of 0.5, 2, 5 and 10 mg
Time frame: 1 day
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) as Assessed by Medical Dictionary for Regulatory Activities (MedDRA) Dictionary, Version 16.0.
Time frame: 1 day

Results and safety

Results posted to the registry on 10 Aug 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
All Study Participants	16	16

Primary outcome: Maximum Plasma Concentration (Cmax) of Infacort vs Hydrocortisone

Time frame: -1h, -0.5h, 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 6.5h, 7h, 7.5h, 8h, 9h, 10h, 11h, 12h. Geometric mean (Geometric Coefficient of Variation). Unit: nmol/L

Measure	Infacort 10mg n = 14	Hydrocortisone n = 14
Value	601.843 (21.5)	622.384 (15.8)

Population analysed: Two subjects were excluded from the Infacort 10mg analysis population due to inadequate endogenous cortisol suppression prior to dosing.

Primary outcome: Time to Reach the Maximum Plasma Concentration (Tmax) of Infacort vs Hydrocortisone

Time frame: -1h, -0.5h, 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 6.5h, 7h, 7.5h, 8h, 9h, 10h, 11h, 12h. Median (Standard Deviation). Unit: Hour

Measure	Infacort 10mg n = 14	Hydrocortisone n = 14
Value	0.500 (0.4031)	1 (0.4171)

Population analysed: Two subjects were excluded from the Infacort 10mg analysis population due to inadequate endogenous cortisol suppression prior to dosing.

Primary outcome: Area Under the Curve (AUC0-t) of Infacort vs Hydrocortisone

Time frame: -1h, -0.5h, 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 6.5h, 7h, 7.5h, 8h, 9h, 10h, 11h, 12h. Geometric mean (Geometric Coefficient of Variation). Unit: hr*nmol/L

Measure	Infacort 10 mg n = 14	Hydrocortisone n = 14
Value	1836.718 (17.8)	1803.278 (14.6)

Population analysed: Two subjects were excluded from the Infacort 10mg analysis population due to inadequate endogenous cortisol suppression prior to dosing.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From study start (19 July 2013) to completion (9 September 2013). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Infacort 0.5 mg	0 of 16 (0%)	1 of 16 (6.3%)	Not reported
Infacort 2 mg	0 of 16 (0%)	1 of 16 (6.3%)	Not reported
Infacort 5 mg	0 of 16 (0%)	0 of 16 (0%)	Not reported
Infacort 10 mg	0 of 16 (0%)	4 of 16 (25%)	Not reported
Hydrocortisone	0 of 16 (0%)	1 of 16 (6.3%)	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

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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, MD principal investigator

Simbec Research

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Infacort and Hydrocortisone in people with Healthy Subjects, run by Neurocrine UK Limited.

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 11 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.

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 10 Aug 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 Plasma Concentration (Cmax) of Infacort vs Hydrocortisone (time frame: -1h, -0.5h, 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 6.5h, 7h, 7.5h, 8h, 9h, 10h, 11h, 12h). The study lists 3 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 NCT02777268.

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.