MedDataX Logo

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

NCT ID: NCT03178214

Last Updated: 2017-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-22

Study Completion Date

2017-07-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Adrenal Insufficiency

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Infacort

Intervention Type DRUG

Immediate-release multiparticulate formulation of hydrocortisone.

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.

Group Type EXPERIMENTAL

Infacort

Intervention Type DRUG

Immediate-release multiparticulate formulation of hydrocortisone.

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.

Group Type ACTIVE_COMPARATOR

Infacort

Intervention Type DRUG

Immediate-release multiparticulate formulation of hydrocortisone.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Infacort

Immediate-release multiparticulate formulation of hydrocortisone.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Simbec Research

INDUSTRY

Sponsor Role collaborator

EMAS Pharma

INDUSTRY

Sponsor Role collaborator

Voet Consulting

INDUSTRY

Sponsor Role collaborator

Brush Clinical Research Ltd.

INDUSTRY

Sponsor Role collaborator

Medical Matters International Ltd

INDUSTRY

Sponsor Role collaborator

Neurocrine UK Limited

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Simbec Research Ltd.

Merthyr Tydfil, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Infacort 006

Identifier Type: -

Identifier Source: org_study_id