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Bioavailability of Infacort When Administered Onto Food Compared to Direct Oral Administration | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Bioavailability of Infacort When Administered Onto Food Compared to Direct Oral Administration

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

NCT03178214•Neurocrine UK Limited

View on ClinicalTrials.gov

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. The study will comprise of a pre-study screen, followed by 3 treatment periods and a post-study follow-up.

Eligibility

Age

18 - 45 years

Sex

MALE

Healthy Volunteers

Yes

Inclusion Criteria

•1. Healthy male subjects between 18 and 45 years of age, inclusive (at screening).
•2. A BMI of 18-30 kg/m2 (inclusive).
•3. No clinically significant abnormal serum biochemistry, haematology or urine examination values as defined by the Investigator.
•4. A negative urinary drugs of abuse screen. A positive alcohol test may be repeated at the discretion of the Investigator.
•5. Negative HIV and Hepatitis B and C results.
•6. No clinically significant abnormalities in 12-lead ECG as defined by the Investigator.
•7. 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).
•8. 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
+4 more criteria

Exclusion Criteria

•1. A clinically significant history of gastrointestinal disorder likely to influence drug absorption.
•2. 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).
•3. Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction.
•4. Receipt of any vaccination within the previous one month.
•5. Presence of infections (systemic fungal and viral infections, acute bacterial infections).
•6. Current or previous history of tuberculosis.
•7. 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).
•8. Meeting any of the contraindications for dexamethasone, as detailed in the Summary of Product Characteristics (SmPC).
•9. A clinically significant history of drug or alcohol abuse.
•10. Inability to communicate well with the Investigator (i.e., language problem, poor mental development or impaired cerebral function).
+5 more criteria

Locations (1)

Simbec Research Ltd.

Merthyr Tydfil, United Kingdom

Key Dates

Start Date

May 22, 2017

Primary Completion Date

July 26, 2017

Completion Date

July 26, 2017

Last Updated

November 9, 2017

Enrollment

ACTUAL participants

Conditions

Adrenal Insufficiency

Interventions

Infacort

DRUG

Evaluation of Children With Endocrine and Metabolic-Related Conditions

NCT02769975

Adrenal InsufficiencyGrowth Disorder+3 more

View study

TERMINATED

A European Post-Authorisation Observational Study (Registry) of Patients With Chronic Adrenal Insufficiency (AI)

NCT01661387

Chronic Adrenal Insufficiency

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 9, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Bioavailability of Infacort When Administered Onto Food Compared to Direct Oral Administration

Inclusion Criteria

Exclusion Criteria

Evaluation of Children With Endocrine and Metabolic-Related Conditions

A European Post-Authorisation Observational Study (Registry) of Patients With Chronic Adrenal Insufficiency (AI)

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