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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03019614
• Date of registration: 11/01/2017
• Prospective Registration: No
• Primary sponsor: Diurnal Limited
• Public title: An Open Label Study in Healthy Volunteers to Compare Chronocort® to Hydrocortisone
• Scientific 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
• Date of first enrolment: March 2010
• Target sample size: 30
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03019614
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Contacts

• Name: Salvatore Febbraro
• Affiliation: Simbec Research

Key inclusion & exclusion 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).



Age minimum: 18 Years
Age maximum: 60 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Congenital Adrenal Hyperplasia

Adrenal Insufficiency

Intervention(s)

Drug: Hydrocortisone

Drug: Chronocort

Primary Outcome(s)

Derived pharmacokinetic parameter: AUC(0 - t) (Area under the curve) [Time Frame: 24 hours]

Derived pharmacokinetic parameter: Tmax [Time Frame: 24 hours]

Derived pharmacokinetic parameter: Tlag [Time Frame: 24 hours]

Derived pharmacokinetic parameter: CL [Time Frame: 24 hours]

Derived pharmacokinetic parameter: Cmax [Time Frame: 24 hours]

Derived pharmacokinetic parameter: AUC(0-8)(Area under the curve) [Time Frame: 24 hours]

Derived pharmacokinetic parameter: T1/2 [Time Frame: 24 hours]

Secondary ID(s)

DIUR-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Simbec Research