Adrenal InsufficiencyPhase 1NCT03178214
Bioavailability of Infacort When Administered Onto Food Compared to Direct Oral Administration
A Phase 1 study testing Infacort in people with Adrenal Insufficiency, run by Neurocrine UK Limited at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Adrenal Insufficiency
- What is being tested?
- Infacort
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 May 2017to 26 Jul 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects between 18 and 45 years of age, inclusive (at screening).
- A BMI of 18-30 kg/m2 (inclusive).
- No clinically significant abnormal serum biochemistry, haematology or urine examination values as defined by the Investigator.
- A negative urinary drugs of abuse screen. A positive alcohol test may be repeated at the discretion of the Investigator.
- Negative HIV and Hepatitis B and C results.
- No clinically significant abnormalities in 12-lead ECG as defined by the Investigator.
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- No clinically significant deviation outside the normal ranges for blood pressure and heart rate measurements as defined by the Investigator (please refer to appendix 1 for normal ranges).
- 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 2 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 all three periods of the study and the follow-up visit.
- Subjects must satisfy a medical examiner about their fitness to participate in the study.
- Subjects must be able to read and understand the informed consent form and 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 any medication other than paracetamol within the 14 days prior to dosing (including topical steroids, high dose vitamins, dietary supplements or herbal remedies).
- Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction.
- Receipt of any vaccination within the previous one month.
- Presence of 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, dexamethasone and/or any of the ingredients contained within the yoghurt or soft food (this includes lactose intolerance).
- Meeting any of the contraindications for dexamethasone, as detailed in the Summary of Product Characteristics (SmPC).
- 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 or marketed drug clinical study within the previous 3 months or, five half-lives of study drug, whichever is the longer period. (NB. the three month 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 two units of alcohol per day within seven days prior to the first dose or have consumed any alcohol within the 48-hour period prior to the first dose.
- Donation or receipt of equal to/more than 450 mL of blood within the previous three months.
- Subjects who smoke (or ex-smokers who have smoked within six months prior to first dose. This includes e-cigarette and shisha users).
- Subjects who work shifts (i.e. regularly alternate between days, afternoons and nights).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
- Conditions
- Adrenal Insufficiency
- Being tested
- Infacort
- Medical subject headings
- Adrenal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InfacortDrug
Immediate-release multiparticulate formulation of hydrocortisone.
| Study group | Role | What they receive |
|---|---|---|
| Infacort - Yoghurt | Experimental | One single 5mg dose of Infacort will be sprinkled onto 5mL of yoghurt and swallowed within three minutes. This will be taken with 240mL of water. Receives: Drug: Infacort |
| Infacort - Soft Food | Experimental | One single 5mg dose of Infacort will be sprinkled onto 5mL of soft food (such as applesauce) and swallowed within three minutes. This will be taken with 240mL of water. Receives: Drug: Infacort |
| Infacort - Dry Granules | Active comparator | One single 5mg dose of Infacort will be administered as dry granules to the back of the tongue and swallowed. This will be taken with 240mL of water. Receives: Drug: Infacort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve (AUC) (0-t) of Infacort administered with yoghurt and soft food compared to dry granules administered to the back of the tongue
The pharmacokinetic parameter AUC0-inf of Infacort® administered as sprinkles with yoghurt and soft food compared to Infacort® administered as dry granules to the back of the tongue.
Measured: 12 hours post-IMP administration
Area under the curve (AUC) (0-infinity) of Infacort administered with yoghurt and soft food compared to dry granules administered to the back of the tongue
The pharmacokinetic parameter AUC0-inf of Infacort® administered as sprinkles with yoghurt and soft food compared to Infacort® administered as dry granules to the back of the tongue.
Measured: 12 hours post-IMP administration
Cmax of Infacort administered with yoghurt and soft food compared to dry granules administered to the back of the tongue.
The pharmacokinetic parameter Cmax of Infacort® administered as sprinkles with yoghurt and soft food compared to Infacort® administered as dry granules to the back of the tongue.
Measured: Up to 12 hours post-IMP adminstration
Secondary outcomes (1)
Tmax of Infacort® administered as sprinkles with yoghurt and soft food compared to Infacort® administered as dry granules to the back of the tongue.
Tmax of Infacort® administered as sprinkles with yoghurt and soft food compared to Infacort® administered as dry granules to the back of the tongue.
Measured: Up to 12 hours post-IMP administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2017
- Study start22 May 2017
- Primary completion26 Jul 2017
- Study completion26 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurocrine UK Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Simbec Research, EMAS Pharma, Voet Consulting, Brush Clinical Research Ltd., Medical Matters International Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03178214
- Sponsor's protocol ID
- Infacort 006
- Status last verified
- Sep 2026
- First submitted
- 27 May 2017
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03178214
- Acronym / sponsor ID
- Infacort 006
- Conditions
- Adrenal Insufficiency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Neurocrine UK LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Simbec Research, EMAS Pharma, Voet Consulting, Brush Clinical Research Ltd., Medical Matters International Ltd
- Study start
- 22 May 2017 (actual)
- Primary completion
- 26 Jul 2017 (actual)
- Study completion
- 26 Jul 2017 (actual)
- First posted
- 6 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Infacort - Yoghurt | Experimental | Drug: InfacortOne single 5mg dose of Infacort will be sprinkled onto 5mL of yoghurt and swallowed within three minutes. This will be taken with 240mL of water. |
| Infacort - Soft Food | Experimental | Drug: InfacortOne single 5mg dose of Infacort will be sprinkled onto 5mL of soft food (such as applesauce) and swallowed within three minutes. This will be taken with 240mL of water. |
| Infacort - Dry Granules | Active comparator | Drug: InfacortOne single 5mg dose of Infacort will be administered as dry granules to the back of the tongue and swallowed. This will be taken with 240mL of water. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Healthy male subjects between 18 and 45 years of age, inclusive (at screening).
- A BMI of 18-30 kg/m2 (inclusive).
- No clinically significant abnormal serum biochemistry, haematology or urine examination values as defined by the Investigator.
- A negative urinary drugs of abuse screen. A positive alcohol test may be repeated at the discretion of the Investigator.
- 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 any medication other than paracetamol within the 14 days prior to dosing (including topical steroids, high dose vitamins, dietary supplements or herbal remedies).
- Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction.
- Receipt of any vaccination within the previous one month.
- Presence of 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 |
|---|---|---|
| InfacortImmediate-release multiparticulate formulation of hydrocortisone. | Drug | Infacort - Dry Granules, Infacort - Soft Food, Infacort - Yoghurt |
Primary outcome
Area under the curve (AUC) (0-t) of Infacort administered with yoghurt and soft food compared to dry granules administered to the back of the tongue
Time frame: 12 hours post-IMP administration
The pharmacokinetic parameter AUC0-inf of Infacort® administered as sprinkles with yoghurt and soft food compared to Infacort® administered as dry granules to the back of the tongue.
Area under the curve (AUC) (0-infinity) of Infacort administered with yoghurt and soft food compared to dry granules administered to the back of the tongue
Time frame: 12 hours post-IMP administration
The pharmacokinetic parameter AUC0-inf of Infacort® administered as sprinkles with yoghurt and soft food compared to Infacort® administered as dry granules to the back of the tongue.
Cmax of Infacort administered with yoghurt and soft food compared to dry granules administered to the back of the tongue.
Time frame: Up to 12 hours post-IMP adminstration
The pharmacokinetic parameter Cmax of Infacort® administered as sprinkles with yoghurt and soft food compared to Infacort® administered as dry granules to the back of the tongue.
1 secondary outcome
Tmax of Infacort® administered as sprinkles with yoghurt and soft food compared to Infacort® administered as dry granules to the back of the tongue.
Time frame: Up to 12 hours post-IMP administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Infacort in people with Adrenal Insufficiency, run by Neurocrine UK Limited at 1 site in United Kingdom.
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 14 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Area under the curve (AUC) (0-t) of Infacort administered with yoghurt and soft food compared to dry granules administered to the back of the tongue (time frame: 12 hours post-IMP administration). 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?
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 14 Sep 2026.