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

Adrenal Insufficiency Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03019614
• Other study ID #: DIUR-001
• Status: Completed
• Phase: Phase 1
• First received: January 11, 2017
• Last updated: January 11, 2017
• Start date: March 2010
• Est. completion date: April 2010

Study information

• Verified date: January 2017
• Source: Diurnal Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adrenal Hyperplasia, Congenital
• Adrenal Insufficiency
• Adrenogenital Syndrome
• Congenital Adrenal Hyperplasia
• Hyperplasia

Intervention

Drug:
• Hydrocortisone
Generic hydrocortisone
• Chronocort
Modified formulation of hydrocortisone

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Diurnal Limited	Simbec Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Derived pharmacokinetic parameter: Tmax	Tmax measures the time at which Cmax - maximum serum concentration - is observed	24 hours	No
Primary	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)	24 hours	No
Primary	Derived pharmacokinetic parameter: Cmax	Cmax measures the time taken for the drug/metabolite to reach maximum serum concentration	24 hours	No
Primary	Derived pharmacokinetic parameter: AUC(0 - t) (Area under the curve)	Area under the serum concentration versus time curve from time	24 hours	No
Primary	Derived pharmacokinetic parameter: AUC(0-8)(Area under the curve)	Area under the serum concentration versus time curve from time = 0h extrapolated to infinity	24 hours	No
Primary	Derived pharmacokinetic parameter: CL	Time to drug clearance	24 hours	No
Primary	Derived pharmacokinetic parameter: T1/2	Time required to reach 1/2 Cmax	24 hours	No