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

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

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).
    


Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Derived pharmacokinetic parameter: Tmax


Condition

Congenital Adrenal Hyperplasia

Intervention

Hydrocortisone

Study Arms / Comparison Groups

 Group 1
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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

30

Start Date

March 2010

Completion Date

April 2010

Primary Completion Date

April 2010

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).
      

Gender

Male

Ages

18 Years - 60 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Salvatore Febbraro, , 



Administrative Informations


NCT ID

NCT03019614

Organization ID

DIUR-001


Responsible Party

Sponsor

Study Sponsor

Diurnal Limited

Collaborators

 Simbec Research

Study Sponsor

Salvatore Febbraro, Principal Investigator, Simbec Research


Verification Date

January 2017