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

Diurnal

Status and phase: Completed; Phase 1

Conditions: Adrenal Insufficiency; Congenital Adrenal Hyperplasia

Treatments: Drug: Hydrocortisone; Drug: Chronocort

Study type: Interventional

Funder types: Industry

Identifiers

NCT03019614

DIUR-001

Details and patient eligibility

About

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).

Enrollment: 30 patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: Accepts 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Group 1

Experimental group

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.

Treatment:

Drug: Chronocort

Drug: Hydrocortisone

Group 2

Experimental group

Description:

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.

Treatment:

Drug: Chronocort