Adrenal Insufficiency MedDRA version: 14.1 Level: LLT Classification code 10001369 Term: Adrenal insufficiency NOS System Organ Class: 100000004860
Conditions
Interventions
Product Name: Infacort (0.5mg granule)
Pharmaceutical Form: Granules
INN or Proposed INN: Hydrocortisone
CAS Number: 50237
Other descriptive name: Cortisol
Concentration unit: mg milligram(s)
Concentr
Sponsors
Diurnal Ltd
Eligibility
Sex/Gender
Male
Inclusion 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 prior to the first dose. •Subjects with a negative urinary drugs of abuse screen, determined within 14 days prior to the first dose. •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 prior to the first dose. •Subjects with no clinically-significant deviation outside the normal ranges for blood pressure and pulse measurements. •Subjects and sexual partners must use 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 spermicide + condom •Subjects must be available to complete the study. •Subjects must satisfy a medical examiner about their fitness to participate in the study. •Subjects must provide written informed consent to participate in the study. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 16 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: •A clinically significant history of gastrointestinal disorder likely to influence drug absorption. •Receipt of regular medication within 14 days prior to the first dose (including high dose vitamins, dietary supplements or herbal remedies). •Receipt of any vaccination within 14 days prior to the first dose. •Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction. •Presence of clinically significant infections (systemic fungal and viral infections, acute bacterial infections) •Current or previous history of tuberculosis •A clinically significant history of previous allergy / sensitivity to Hydrocortisone and/or Dexamethasone. •A clinically significant history or family history of psychiatric disorders/illnesses. •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. (N.B. The washout period between trials is defined as the period of time elapsed between the last dose of the previous study and the first dose of the next study) •Subjects who have consumed more than 2 units of alcohol per day within seven (7) days prior to the first dose or have consumed any alcohol within the 48 hour period prior to the first dose. •Donation of 450ml or more of blood within the previous 12 weeks. •Subjects who smoke (or ex-smokers who have smoked within 6 months prior to first dose). •Subjects who work shifts (i.e. regularly alternate between days, afternoons and nights).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objectives •To compare the pharmacokinetics of Infacort® versus immediate-release hydrocortisone in a single dose of 10mg. •To determine the dose proportionality for Infacort® at doses of 0.5mg, 2mg, 5mg and 10mg.;Secondary Objective: Secondary objective •To assess the safety and tolerability of Infacort® throughout the study. ;Primary end point(s): Pharmacokinetic Variables (Serum Cortisol concentrations) •Cmax Maximum plasma cortisol concentration •tmax The time to maximum observed cortisol concentration sampled during a dosing interval •?z Elimination rate constant •t1/2 Terminal half-life •AUC0-t Area under the plasma cortisol concentration-time curve (AUC) from the time of dosing to the time of the last observed concentration,regardless of whether or not the last concentration is measurable •AUC0-inf The area under the curve (AUC) extrapolated to infinity from dosing time, based on the last observed concentration •CL/F plasma clearance, calculated as Dose / AUC0-inf ;Timepoint(s) of evaluation of this end point: Treatment Periods 1, 2, 3, 4 and 5: Day 2: -1, -0.5, 0, 0.5 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 11, 12hr | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety: Adverse events, vital signs, 12-lead ECG and laboratory safety test results.;Timepoint(s) of evaluation of this end point: Adverse events: Continually monitored throughout study Vital Signs: Screening, Day 2 pre-dose, and at 12 hours post dose during each treatment period 12-lead ECG: Screening, Post Study Laboratory Safety tests: Screening, Day 1 (all treatment periods), Post Study | — |
Countries
United Kingdom
Contacts
Public ContactOliver Knott
Simbec Research Ltd
Outcome results
None listed