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

NCT ID: NCT03019614

Last Updated: 2017-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2010-04-30

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).

Conditions

Congenital Adrenal Hyperplasia; Adrenal Insufficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1

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.

Group Type: EXPERIMENTAL

Hydrocortisone

Intervention Type: DRUG

Generic hydrocortisone

Chronocort

Intervention Type: DRUG

Modified formulation of hydrocortisone

Group 2

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.

Group Type: EXPERIMENTAL

Chronocort

Intervention Type: DRUG

Modified formulation of hydrocortisone

Interventions

Hydrocortisone

Generic hydrocortisone

Intervention Type: DRUG

Chronocort

Modified formulation of hydrocortisone

Intervention Type: DRUG

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Simbec Research

INDUSTRY

Sponsor Role: collaborator

Neurocrine UK Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Salvatore Febbraro

Role: PRINCIPAL_INVESTIGATOR

Simbec Research

Other Identifiers

DIUR-001

Identifier Type: -

Identifier Source: org_study_id