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Comparison of Pharmacokinetics of Infacort® Versus Immediate-release Hydrocortisone

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ClinicalTrials.gov Identifier: NCT02777268
Recruitment Status : Completed
First Posted : May 19, 2016
Results First Posted : August 10, 2017
Last Update Posted : December 2, 2017
Sponsor:
Collaborator:
Simbec Research
Information provided by (Responsible Party):
Diurnal Limited

Brief Summary:
This was a single centre, open-label, randomised, 5-way crossover study.

Condition or disease Intervention/treatment Phase
Healthy Subjects Drug: Infacort Drug: Hydrocortisone Phase 1

Detailed Description:
This was a single centre, open-label, randomised, 5-way crossover study design to compare the PK of Infacort® versus immediate-release hydrocortisone tablets and to evaluate the dose proportionality of 0.5 mg, 2 mg, 5 mg and 10 mg Infacort®. The study was conducted in 1 cohort of 16 healthy male subjects and comprised a Screening Visit, 5 treatment periods (Treatment Periods 1 to 5) and a Post-study Visit.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Single Centre, Open Label, Randomised, Crossover Study in Dexamethasone-suppressed Healthy Adult Male Volunteers to Compare the Pharmacokinetics of Infacort® Versus Immediate-release Hydrocortisone Tablets at a Single Dose of 10 mg and to Evaluate the Dose Proportionality of Infacort® at Doses of 0.5 mg, 2 mg, 5 mg and 10 mg
Study Start Date : July 2013
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013


Arm Intervention/treatment
Experimental: Infacort 0.5 mg
Multi-particulate granules from 1 (0.5 mg) capsule
Drug: Infacort
Multi-particulate granules

Experimental: Infacort 2 mg
Multi-particulate granules from 1 (2 mg) capsule
Drug: Infacort
Multi-particulate granules

Experimental: Infacort 5 mg
Multi-particulate granules from 1 (5 mg) capsule
Drug: Infacort
Multi-particulate granules

Experimental: Infacort 10 mg
Multi-particulate granules from 1 (10 mg) capsule
Drug: Infacort
Multi-particulate granules

Active Comparator: Hydrocortisone
1 (10 mg) tablet
Drug: Hydrocortisone
Tablet




Primary Outcome Measures :
  1. Maximum Plasma Concentration (Cmax) of Infacort vs Hydrocortisone [ Time Frame: -1h, -0.5h, 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 6.5h, 7h, 7.5h, 8h, 9h, 10h, 11h, 12h ]
    To compare the Cmax of Infacort® versus immediate-release hydrocortisone in a single dose of 10 mg.

  2. Time to Reach the Maximum Plasma Concentration (Tmax) of Infacort vs Hydrocortisone [ Time Frame: -1h, -0.5h, 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 6.5h, 7h, 7.5h, 8h, 9h, 10h, 11h, 12h ]
    To compare the Tmax of Infacort® versus immediate-release hydrocortisone in a single dose of 10 mg.

  3. Area Under the Curve (AUC0-t) of Infacort vs Hydrocortisone [ Time Frame: -1h, -0.5h, 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 6.5h, 7h, 7.5h, 8h, 9h, 10h, 11h, 12h ]
    To compare the AUC0-t of Infacort® versus immediate-release hydrocortisone in a single dose of 10 mg. AUC0-t represents the total exposure to drug over time, hence the reporting of a single value below.


Secondary Outcome Measures :
  1. Maximum Plasma Concentration (Cmax) of Infacort at Doses of 0.5, 2, 5 and 10 mg [ Time Frame: -1h, -0.5h, 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 6.5h, 7h, 7.5h, 8h, 9h, 10h, 11h, 12h ]
    To determine the dose proportionality for Infacort® at doses of 0.5 mg, 2 mg, 5 mg and 10 mg.

  2. Time to Maximum Plasma Concentration (Tmax) of Infacort at Doses of 0.5, 2, 5 and 10 mg [ Time Frame: -1h, -0.5h, 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 6.5h, 7h, 7.5h, 8h, 9h, 10h, 11h, 12h ]
    To determine the dose proportionality for Infacort® at doses of 0.5 mg, 2 mg, 5 mg and 10 mg.

  3. Area Under the Curve (AUC0-t) of Infacort at Doses of 0.5, 2, 5 and 10 mg [ Time Frame: 1 day ]
    To determine the dose proportionality for Infacort® at doses of 0.5 mg, 2 mg, 5 mg and 10 mg.

  4. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) as Assessed by Medical Dictionary for Regulatory Activities (MedDRA) Dictionary, Version 16.0. [ Time Frame: 1 day ]
    To assess the safety and tolerability of Infacort® throughout the study. For a full list of TEAEs per arm, please refer to the Adverse Events section.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male volunteers between 18 and 60 years of age, inclusive (at Screening Visit).
  • Subjects with a Body Mass Index (BMI) of 21-28.
  • Subjects with no clinically significant abnormal serum biochemistry, haematology and urine examination values within 14 days prior to the first dose of investigational medicinal product (IMP).
  • Subjects with a negative urinary drugs of abuse screen determined within 14 days prior to the first dose of IMP. A positive alcohol test may have been repeated at the discretion of the Investigator.
  • Subjects with negative human immunodeficiency virus (HIV) and hepatitis B surface antigen (Hep B) and hepatitis C virus antibody (Hep C) results.
  • Subjects with no clinically significant abnormalities in 12-lead electrocardiogram (ECG) determined within 14 days prior to the first dose of IMP.
  • Subjects with no clinically-significant deviation outside the normal ranges for blood pressure and pulse measurements.
  • Subjects (unless anatomically sterile or where abstaining from sexual intercourse was in-line with the preferred and usual lifestyle of the subject) and sexual partners used effective contraception methods during the trial and for 3 months after the last dose of IMP, for example; oral contraceptive + condom, intra-uterine device (IUD) + condom or diaphragm with spermicide + condom.
  • Subjects were available to complete the study.
  • Subjects satisfied a medical examiner about their fitness to participate in the study.
  • Subjects provided written informed consent to participate in the study.

Exclusion Criteria:

  • A clinically significant history of gastrointestinal disorder likely to influence drug absorption.
  • Receipt of regular medication within 14 days prior to the first dose of IMP (including high dose vitamins, dietary supplements or herbal remedies).
  • Receipt of any vaccination within 14 days prior to the first dose of IMP.
  • Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction.
  • Presence of clinically significant 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 and/or dexamethasone.
  • A clinically significant history or family history of psychiatric disorders/illnesses.
  • 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).
  • Participated in a New Chemical Entity clinical study within the previous 4 months or a marketed drug clinical study within the previous 3 months. (N.B. The washout period between trials was 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 had consumed more than 2 units of alcohol per day within 7 days prior to the first dose of IMP or had consumed any alcohol within the 48 hr period prior to the first dose of IMP.
  • Donation of 450 mL or more of blood within the previous 3 months.
  • Subjects who smoked (or ex-smokers who had smoked within 6 months prior to first dose of IMP).
  • Subjects who worked shifts (i.e. regularly alternated between days, afternoons and nights).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02777268


Sponsors and Collaborators
Diurnal Limited
Simbec Research
Investigators
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Principal Investigator: Girish Sharma, MD Simbec Research

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Responsible Party: Diurnal Limited
ClinicalTrials.gov Identifier: NCT02777268     History of Changes
Other Study ID Numbers: Infacort 001
First Posted: May 19, 2016    Key Record Dates
Results First Posted: August 10, 2017
Last Update Posted: December 2, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Anti-Inflammatory Agents