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Trial registered on ANZCTR


Registration number
ACTRN12610000798066
Ethics application status
Approved
Date submitted
24/09/2010
Date registered
24/09/2010
Date last updated
19/10/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Phase I, Randomised, Open-Label, Three-way Crossover Comparative Pharmacokinetic Study of EMA401 Sodium Salt When Administered Orally in Fed (high fat meal or orange juice only) and Fasted Healthy Adult Males.
Scientific title
A Phase I, Randomised, Open-Label, Three-way Crossover Comparative Pharmacokinetic Study of EMA401 Sodium Salt When Administered Orally in Fed (high fat meal or orange juice only) and Fasted Healthy Adult Males.
Secondary ID [1] 252750 0
EMA401-001D, Spinifex Pharmaceuticals Pty Ltd
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postherpetic Neuralgia 258251 0
Condition category
Condition code
Neurological 258445 258445 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
EMA401 Sodium Salt at a dose level of 50 mg EMA401 equivalent (2 x 25 mg capsules) will be administered orally as a single dose to subjects in each dosing period, either in the fasted state, following a standard high fat meal, or with 250 mL of orange juice with no added sugar.
All subjects will be required to fast for at least 10 hours overnight prior to dosing. EMA401 will be administered to the following treatment groups:
Fasted; two 25 mg capsules with 240 mL of non-carbonated water.
High fat meal; two 25 mg capsules with 240 mL of non-carbonated water, following a standardised high fat and high caloric breakfast (50% fat and 800 to 1000 Kcal), starting 30 minutes prior to dose administration.
Orange juice only: two 25 mg capsules with 250 mL of commercially available orange juice with no added sugar.
All subjects will then consume no further food until 4 hours post-dose. There will be a minimum 7-day wash-out between each treatment period.
Intervention code [1] 257269 0
Treatment: Drugs
Comparator / control treatment
This study is a three-period, three-way crossover design. In each period, following an overnight fast of at least 10 hours, five subjects will be randomised to the fasted dose administration, another five subjects will be randomised to the fed dose administration and the remaining five subjects randomised to receiving orange juice only. Over the three periods, each subject will be allocated once to each mode of dose administration.
Control group
Active

Outcomes
Primary outcome [1] 259280 0
To determine the effects of food on the pharmacokinetics of EMA401 after a single oral dose of EMA401 Sodium Salt, comparing dose administration following a high fat meal or with orange juice against dose administration in the fasted state, in healthy adult males.
Timepoint [1] 259280 0
In each of the 3 treatment periods, blood samples for pharmacokinetic analysis will be taken at pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose following each dose administration (18 samples in each period, 54 samples in total).
Secondary outcome [1] 265703 0
Nil
Timepoint [1] 265703 0
Nil

Eligibility
Key inclusion criteria
Male and aged between 18 and 55 years (inclusive); Healthy subjects - healthy subjects are defined as individuals who are free from clinically significant illness or disease as determined by their medical/surgical history, physical examination (including height and weight), 12-lead Electrocardiogram (ECG) and clinical laboratory determinations; Normotensive (systolic blood pressure between 90 mmHg and 140 mmHg inclusive and diastolic blood pressure between 60 mmHg and 90 mmHg inclusive); No clinically relevant abnormality in an ECG; QTcF (QTc Fridericia’s correction) less than or equal to 450 ms, PR interval of 120-210 ms and a QRS duration less than or equal to 100 ms; Semi-supine pulse rate after resting for 5 minutes greater than 45 bpm (beats per minute) and less than 100 bpm; Individuals who smoked less than 5 cigarettes or tobacco forms (including cigars) per month in the last 12 months; Adequate venous access in the left or right arm to allow collection of a number of blood samples; Body Mass Index (BMI) between 18.5 kg/m2 and 32.0 kg/m2 inclusive; Agrees to adhere to dietary requirements; Agrees to use two approved methods of contraception from Screening and until 30 days after last drug administration of the study drug. Agreed methods of contraception may include condom, use of approved birth control pills, patches, implants or injections by the subject’s partner, use of diaphragm with vaginal spermacide by the subject’s partner, use of an IUD (intra uterine device) by the subject’s partner and/or surgical sterilization (vasectomy at least six months prior to dosing); Have given written informed consent to participate in this study in accordance with local regulations.
Minimum age
18 Years
Maximum age
55 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Have received or is anticipated to receive a new prescription systemic or topical medication within 14 days prior to the start of dosing or an over–the-counter medicine 48 hours prior to the start of dosing; Any condition that would interfere with drug absorption (e.g. chronic diarrhoea); Abnormal laboratory test results deemed clinically significant by the Medical Officer (Principal Investigator or medically qualified nominee) within 21 days of enrolment, including anaemia (haemoglobin less than 110 g/L), neutropenia, thrombocytopenia and elevated liver function test results (Aspartate transaminase (AST) and Alanine transaminase (ALT)) more than 1.5 times the upper limit of normal; Males known to have experienced elevated liver enzymes or altered white cell counts in any previous clinical study; Evidence of significant renal insufficiency, as indicated by an estimated creatinine clearance using the Cockcroft-Gault formula of less than 75 mL/min at Screening; As a result of medical review, physical examination (including height and weight) or Screening investigations, the Medical Officer considers the subject unfit for the study; Known history of lactose intolerance or allergy to milk products; Positive urine drug test or alcohol breath test; Use of macrolide antibiotics (eg. erythromycin), azole antifungal agents (eg. Ketoconazole) within 30 days of study dosing; History or clinical evidence of oral, cardiovascular, cerebrovascular, haematological, gastrointestinal, hepatic, renal, endocrine, pulmonary, neurological, psychiatric or skin disorder which, in the opinion of the Principal Investigator (or medically qualified nominee) would compromise the participant’s safety or other aspects of the study; History of epilepsy; History or clinical evidence of significant cardiovascular disease including ischaemic heart disease, peripheral vascular disease, uncontrolled hypertension and history of, or risk factors for, cardiac ventricular arrhythmias (e.g. personal history or family history of syncope, long QT syndrome or sudden death); Acute therapy for a serious infection within 30 days of study entry; History of significant drug allergies or significant allergic reaction or currently suffers from clinically significant systemic allergic disease; Positive Screening test for Hepatitis B surface antigen, or Hepatitis C antibody, or HIV (human immunodeficiency virus); Have participated in a clinical trial or have received an experimental therapy within 30 days or 10 half-lives of the drug, whichever is the longer, prior to dosing; Receipt of blood or blood products, or loss or donation of 450 mL or more of blood within 90 days before the first dose administration; Males who regularly drink more than four (4) units of alcohol daily (1 unit = 300 mL beer, 1 glass wine, 1 measure spirit); Males who are unwilling to abide by the study restrictions; Any subject who has previously enrolled in this or any clinical trial of EMA401 Sodium Salt.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects will be allocated to a sequentially numbered treatment in accordance with the randomisation schedule following confirmation of eligibility on Day -1. The Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation schedule created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
This is an open label study. However, the analyst performing the assay of pharmacokinetic blood samples will be blinded to the mode of administration for subjects in each period, and so will not have access to the randomisation schedules during the course of analysis.
Phase
Phase 1
Type of endpoint/s
Pharmacokinetics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
27/09/2010
Actual
17/09/2010
Date of last participant enrolment
Anticipated
Actual
12/10/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
96
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257710 0
Commercial sector/Industry
Name [1] 257710 0
Spinifex Pharmaceuticals Pty Ltd
Country [1] 257710 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Spinifex Pharmaceuticals Pty Ltd
Address
South Yarra Corporate Centre, Suite T18, Level 1, 122 Toorak Road, South Yarra, Victoria, 3141
Country
Australia
Secondary sponsor category [1] 256927 0
None
Name [1] 256927 0
Address [1] 256927 0
Country [1] 256927 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259747 0
Bellberry Limited
Ethics committee address [1] 259747 0
Ethics committee country [1] 259747 0
Australia
Date submitted for ethics approval [1] 259747 0
Approval date [1] 259747 0
30/06/2010
Ethics approval number [1] 259747 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31686 0
Dr Sepehr Shakib
Address 31686 0
CMAX
Level 5, East Wing
Royal Adelaide Hospital, North Terrace
Adelaide, SA 5000
Country 31686 0
Australia
Phone 31686 0
61 8 8222 3923
Fax 31686 0
Email 31686 0
[email protected]
Contact person for public queries
Name 14933 0
Sarah Vickery
Address 14933 0
CPR Pharma Services Pty Ltd, Suite C, 32 West Thebarton Road, Thebarton, SA 5031
Country 14933 0
Australia
Phone 14933 0
+61 8 8125 1926
Fax 14933 0
+61 8 8354 3146
Email 14933 0
[email protected]
Contact person for scientific queries
Name 5861 0
Nuket Desem
Address 5861 0
South Yarra Corporate Centre, Suite T18, Level 1, 122 Toorak Road, South Yarra, Victoria 3141
Country 5861 0
Australia
Phone 5861 0
+61 3 9938 1205
Fax 5861 0
+61 3 9820 8262
Email 5861 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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