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
Overview
- Phase
- Phase 1
- Intervention
- Infacort
- Conditions
- Adrenal Insufficiency
- Sponsor
- Diurnal Limited
- Enrollment
- 19
- Locations
- 1
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
- •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
Exclusion Criteria
- •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.
- •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).
Arms & Interventions
Infacort - Yoghurt
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.
Intervention: Infacort
Infacort - Soft Food
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.
Intervention: Infacort
Infacort - Dry Granules
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.
Intervention: Infacort
Outcomes
Primary Outcomes
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.
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.
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.
Secondary Outcomes
- Tmax of Infacort® administered as sprinkles with yoghurt and soft food compared to Infacort® administered as dry granules to the back of the tongue.(Up to 12 hours post-IMP administration)