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An Open Label Study in Healthy Volunteers to Compare Chronocort® to Hydrocortisone

Primary Purpose

Congenital Adrenal Hyperplasia, Adrenal Insufficiency

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Hydrocortisone

Chronocort

About this trial

This is an interventional treatment trial for Congenital Adrenal Hyperplasia

Eligibility Criteria

18 Years - 60 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

Healthy male volunteers between 18 and 60 years of age, inclusive (at screening).
Subjects with a Body Mass Index (BMI) of 21-28. Body Mass Index = Body weight (kg) / (Height (m))2.
Subjects with no clinically significant abnormal serum biochemistry, haematology and urine examination values within 14 days of the start of the study. The parameters measured included those shown in Appendix 3 of the Study Protocol.
Subjects with a negative urinary drugs of abuse screen (including alcohol), determined within 14 days of the start of the study.
Subjects with negative HIV and Hepatitis B and C results.
Subjects with no clinically significant abnormalities in 12-lead electrocardiogram (ECG) determined within 14 days of the start of the study.
Subjects with no clinically-significant deviation outside the normal ranges for blood pressure and pulse measurements.
Subjects and sexual partners must have used 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 spermacide + condom
Subjects must have been available to complete the study.
Subjects must have satisfied a medical examiner about their fitness to participate in the study.
Subjects must have 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 of the first study day (including high dose vitamins, dietary supplements or herbal remedies).
Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction.
A clinically significant history of previous allergy / sensitivity to Hydrocortisone.
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 clinical study within the previous 16 weeks or a marketed drug clinical study within the previous 12 weeks.
Subjects who had consumed more than 2 units of alcohol per day within seven (7) days prior to the first dose or had consumed any alcohol within the 48 hour period prior to the first dose.
Donation of 450ml or more blood within the previous 12 weeks.
Subjects who worked shifts (i.e. regularly alternated between days, afternoons and nights).

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Group 1

Group 2

Arm Description

Volunteers in group 1 received the following interventions: Chronocort® 30 mg given at night (~ 23:00h) as a combination of one 10mg capsule and one 20mg capsule (n=18). Chronocort® 30mg given as one 20mg capsule at night (~ 23:00h) and as one 10mg capsule in the morning (~ 7:00h) following the initial night-time dose (n=18). Hydrocortisone 30mg given at night (~ 23:00h) given as three 10mg tablets (n=18). Each administration of IMP was separated by a washout period of at least 7 days.

Volunteers in group 2 received the following interventions: Chronocort® 5mg given at night (~ 23:00h) as one 5mg capsule (n=12). Chronocort® 10mg given at night (~ 23:00h) as one 10mg capsule (n=12). Chronocort® 20mg given at night (~ 23:00h) as one 20mg capsule (n=12). Each administration of IMP was separated by a washout period of at least 7 days.

Outcomes

Primary Outcome Measures

Derived pharmacokinetic parameter: Tmax

Tmax measures the time at which Cmax - maximum serum concentration - is observed

Derived pharmacokinetic parameter: Tlag

Tlag measures the delay between dosing and being able to observe the drug/metabolite within the sampling area (e.g., blood serum)

Derived pharmacokinetic parameter: Cmax

Cmax measures the time taken for the drug/metabolite to reach maximum serum concentration

Derived pharmacokinetic parameter: AUC(0 - t) (Area under the curve)

Area under the serum concentration versus time curve from time

Derived pharmacokinetic parameter: AUC(0-∞)(Area under the curve)

Area under the serum concentration versus time curve from time = 0h extrapolated to infinity

Derived pharmacokinetic parameter: CL

Time to drug clearance

Derived pharmacokinetic parameter: T1/2

Time required to reach 1/2 Cmax

Secondary Outcome Measures

Full Information

NCT ID

NCT03019614

First Posted

January 11, 2017

Last Updated

January 11, 2017

Sponsor

Diurnal Limited

Collaborators

Simbec Research

1. Study Identification

Unique Protocol Identification Number

NCT03019614

Brief Title

An Open Label Study in Healthy Volunteers to Compare Chronocort® to Hydrocortisone

Official Title

An Open Label, Randomised, Single Dose, 3-period Crossover Study in Healthy Volunteers to: a) Compare the Pharmacokinetics of Chronocort® Formulations Versus Immediate Release Hydrocortisone, and (b) Determine the Dose Proportionality of Chronocort® Formulations

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Completed

Study Start Date

March 2010 (undefined)

Primary Completion Date

April 2010 (Actual)

Study Completion Date

April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Diurnal Limited

Collaborators

Simbec Research

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This was an open label, randomized, single dose, three period crossover pharmacokinetic study of Chronocort® in 30 healthy male volunteers. The study was conducted in smaller sub groups (Group 1, n=18 and Group 2, n=12).

6. Conditions and Keywords

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

Congenital Adrenal Hyperplasia, Adrenal Insufficiency

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

Experimental

Arm Description

Arm Title

Group 2

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Hydrocortisone

Intervention Description

Generic hydrocortisone

Intervention Type

Drug

Intervention Name(s)

Chronocort

Intervention Description

Modified formulation of hydrocortisone

Primary Outcome Measure Information:

Title

Derived pharmacokinetic parameter: Tmax

Description

Tmax measures the time at which Cmax - maximum serum concentration - is observed

Time Frame

24 hours

Title

Derived pharmacokinetic parameter: Tlag

Description

Tlag measures the delay between dosing and being able to observe the drug/metabolite within the sampling area (e.g., blood serum)

Time Frame

24 hours

Title

Derived pharmacokinetic parameter: Cmax

Description

Cmax measures the time taken for the drug/metabolite to reach maximum serum concentration

Time Frame

24 hours

Title

Derived pharmacokinetic parameter: AUC(0 - t) (Area under the curve)

Description

Area under the serum concentration versus time curve from time

Time Frame

24 hours

Title

Derived pharmacokinetic parameter: AUC(0-∞)(Area under the curve)

Description

Area under the serum concentration versus time curve from time = 0h extrapolated to infinity

Time Frame

24 hours

Title

Derived pharmacokinetic parameter: CL

Description

Time to drug clearance

Time Frame

24 hours

Title

Derived pharmacokinetic parameter: T1/2

Description

Time required to reach 1/2 Cmax

Time Frame

24 hours

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy male volunteers between 18 and 60 years of age, inclusive (at screening). Subjects with a Body Mass Index (BMI) of 21-28. Body Mass Index = Body weight (kg) / (Height (m))2. Subjects with no clinically significant abnormal serum biochemistry, haematology and urine examination values within 14 days of the start of the study. The parameters measured included those shown in Appendix 3 of the Study Protocol. Subjects with a negative urinary drugs of abuse screen (including alcohol), determined within 14 days of the start of the study. Subjects with negative HIV and Hepatitis B and C results. Subjects with no clinically significant abnormalities in 12-lead electrocardiogram (ECG) determined within 14 days of the start of the study. Subjects with no clinically-significant deviation outside the normal ranges for blood pressure and pulse measurements. Subjects and sexual partners must have used 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 spermacide + condom Subjects must have been available to complete the study. Subjects must have satisfied a medical examiner about their fitness to participate in the study. Subjects must have 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 of the first study day (including high dose vitamins, dietary supplements or herbal remedies). Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction. A clinically significant history of previous allergy / sensitivity to Hydrocortisone. 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 clinical study within the previous 16 weeks or a marketed drug clinical study within the previous 12 weeks. Subjects who had consumed more than 2 units of alcohol per day within seven (7) days prior to the first dose or had consumed any alcohol within the 48 hour period prior to the first dose. Donation of 450ml or more blood within the previous 12 weeks. Subjects who worked shifts (i.e. regularly alternated between days, afternoons and nights).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Salvatore Febbraro

Organizational Affiliation

Simbec Research

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

An Open Label Study in Healthy Volunteers to Compare Chronocort® to Hydrocortisone

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