Clinical trial NCT03019614: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Congenital Adrenal Hyperplasia
Adrenal Insufficiency
Lead sponsor: Neurocrine UK Limited
Sponsor class: INDUSTRY
Collaborators: name: Simbec Research
First posted: 2017-01-12
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).


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).

Primary outcomes:
measure: Derived pharmacokinetic parameter: Tmax
timeFrame: 24 hours
measure: Derived pharmacokinetic parameter: Tlag
timeFrame: 24 hours
measure: Derived pharmacokinetic parameter: Cmax
timeFrame: 24 hours
measure: Derived pharmacokinetic parameter: AUC(0 - t) (Area under the curve)
timeFrame: 24 hours
measure: Derived pharmacokinetic parameter: AUC(0-∞)(Area under the curve)
timeFrame: 24 hours
measure: Derived pharmacokinetic parameter: CL
timeFrame: 24 hours
measure: Derived pharmacokinetic parameter: T1/2
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Simbec Research
name: Salvatore Febbraro
role: PRINCIPAL_INVESTIGATOR
References: