search
Back to results

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

Primary Purpose

Adrenal Insufficiency

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Infacort
Sponsored by
Diurnal Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adrenal Insufficiency

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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
    • Diaphragm with spermicide + condom
  9. Subjects must be available to complete all three periods of the study and the follow-up visit.
  10. Subjects must satisfy a medical examiner about their fitness to participate in the study.
  11. Subjects must be able to read and understand the informed consent form and must provide written informed consent to participate in the study.

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).
  11. 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).
  12. 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.
  13. Donation or receipt of equal to/more than 450 mL of blood within the previous three months.
  14. Subjects who smoke (or ex-smokers who have smoked within six months prior to first dose. This includes e-cigarette and shisha users).
  15. Subjects who work shifts (i.e. regularly alternate between days, afternoons and nights).

Sites / Locations

  • Simbec Research Ltd.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Infacort - Yoghurt

Infacort - Soft Food

Infacort - Dry Granules

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
May 27, 2017
Last Updated
November 7, 2017
Sponsor
Diurnal Limited
Collaborators
Simbec Research, EMAS Pharma, Voet Consulting, Brush Clinical Research Ltd., Medical Matters International Ltd
search

1. Study Identification

Unique Protocol Identification Number
NCT03178214
Brief Title
Bioavailability of Infacort When Administered Onto Food Compared to Direct Oral Administration
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
May 22, 2017 (Actual)
Primary Completion Date
July 26, 2017 (Actual)
Study Completion Date
July 26, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Diurnal Limited
Collaborators
Simbec Research, EMAS Pharma, Voet Consulting, Brush Clinical Research Ltd., Medical Matters International Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adrenal Insufficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Infacort - Yoghurt
Arm Type
Experimental
Arm Description
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.
Arm Title
Infacort - Soft Food
Arm Type
Experimental
Arm Description
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.
Arm Title
Infacort - Dry Granules
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Infacort
Intervention Description
Immediate-release multiparticulate formulation of hydrocortisone.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
12 hours post-IMP administration
Title
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
Description
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.
Time Frame
12 hours post-IMP administration
Title
Cmax of Infacort administered with yoghurt and soft food compared to dry granules administered to the back of the tongue.
Description
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.
Time Frame
Up to 12 hours post-IMP adminstration
Secondary Outcome Measure Information:
Title
Tmax of Infacort® administered as sprinkles with yoghurt and soft food compared to Infacort® administered as dry granules to the back of the tongue.
Description
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 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. 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). 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).
Facility Information:
Facility Name
Simbec Research Ltd.
City
Merthyr Tydfil
ZIP/Postal Code
CF48 4DR
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs