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Trial registered on ANZCTR


Registration number
ACTRN12610000961044
Ethics application status
Approved
Date submitted
8/11/2010
Date registered
9/11/2010
Date last updated
19/10/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase I, Open-Label, Twice Daily Dose, Pharmacokinetic Study of EMA401 Sodium Salt Administered Orally in Healthy Elderly Subjects
Scientific title
A Phase I, Open-Label, Twice Daily Dose, Pharmacokinetic Study of EMA401 Sodium Salt Administered Orally in Healthy Elderly Subjects
Secondary ID [1] 253026 0
EMA401-001E, Spinifex Pharmaceuticals Pty Ltd
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postherpetic Neuralgia 258587 0
Condition category
Condition code
Neurological 258724 258724 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
EMA401 Sodium Salt will be administered as two single oral doses of 100 mg EMA401 equivalent (4 x 25 mg capsules) on the same day with a 10 hour interval between doses, for a total daily dose of 200 mg. The treatment phase of the study will last for 1 day.
All subjects will be required to fast for at least 10 hours overnight prior to the first dose. The second dose will be administered 10 hours later. Subjects will be allowed a light lunch between the first and second dosing occasion. Each dose will be administered with a minimum of 240 mL of non-carbonated water. All subjects will consume no food until 4 hours post-dose.
Intervention code [1] 257555 0
Treatment: Drugs
Comparator / control treatment
Not Applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259606 0
To evaluate the pharmacokinetics of EMA401 in healthy elderly subjects, following two oral doses of EMA401 sodium salt, with a ten (10) hour interval between doses.
Timepoint [1] 259606 0
A total of twenty-five (25) blood samples for pharmacokinetic analysis will be taken at pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4 and 6 hours post-dose for the first dose, and at pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36 and 48 hours post-dose for the second dose.
Secondary outcome [1] 266248 0
To determine the safety and tolerability of EMA401 in healthy elderly subjects, following two oral doses of EMA401 sodium salt, with a ten (10) hour interval between doses.
Timepoint [1] 266248 0
The treatment phase of the study will last for 1 day. A single oral dose of 100 mg will be administered in the morning followed by a second oral dose of 100 mg 10 hours later. In this study, subjects will be confined to the study centre from the evening of Day -1 until the last pharmacokinetic blood sample is taken on the evening of Study Exit (Day 3), 48 hours post the second dose. During this time vital signs, physical examination, clinical laboratory determinations and 12 lead electrocardiogram (ECG) readings will be performed. All subjects will be monitored for adverse events and concomitant medications for the duration of the study. All information received between consent and Study Exit (Day 3) will be recorded in the case report form.

Eligibility
Key inclusion criteria
Males and post-menopausal females aged 56 years of age or older; Healthy subjects, 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; Systolic blood pressure between 90 mmHg and 160 mmHg inclusive and Diastolic blood pressure less than or equal to 90 mmHg; 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 of less than or equal to 110 ms; Resting pulse rate after sitting 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; For males only: Agrees to use two approved methods of contraception from Screening and until 30 days after 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
56 Years
Maximum age
No limit
Gender
Both males and females
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 and includes the taking of permitted medications that have not been stable in dosage and regimen for a minimum of 3 months prior to the first day 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 within 28 days before 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; 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 55 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) which in the opinion of the Principal Investigator (or medically qualified nominee) would compromise the participant’s safety or other aspects of the study; 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; 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; Subjects who have received blood or blood products within 90 days before the first dose administration; Subjects who regularly drink more than four (4) units (males) or more than two (2) units (females) of alcohol daily (1 unit = 300 mL beer, 1 glass wine, 1 measure spirit); Subjects who are unwilling to abide by the study restrictions.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint(s)
Pharmacokinetics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258018 0
Commercial sector/Industry
Name [1] 258018 0
Spinifex Pharmaceuticals Pty Ltd
Address [1] 258018 0
South Yarra Corporate Centre, Suite T18, Level 1, 122 Toorak Road, South Yarra, Victoria, 3141
Country [1] 258018 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] 257212 0
None
Name [1] 257212 0
Address [1] 257212 0
Country [1] 257212 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260014 0
Bellberry Limited
Ethics committee address [1] 260014 0
229 Greenhill Road, Dulwich SA 5065
Ethics committee country [1] 260014 0
Australia
Date submitted for ethics approval [1] 260014 0
20/10/2010
Approval date [1] 260014 0
16/11/2010
Ethics approval number [1] 260014 0

Summary
Brief summary
This study is designed to evaluate the pharmacokinetics, safety and tolerability EMA401 in healthy elderly subjects (56 years and over) after two single oral doses of EMA401 Sodium Salt administered on the same day with a 10 hour interval between doses, for a total daily dose of 200 mg.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31872 0
Dr Sepehr Shakib
Address 31872 0
CMAX
Level 5, East Wing
Royal Adelaide Hospital, North Terrace
Adelaide, SA 5000
Country 31872 0
Australia
Phone 31872 0
61 8 8222 3923
Fax 31872 0
Email 31872 0
Sepehr.Shakib@health.sa.gov.au
Contact person for public queries
Name 15119 0
Mr Lien Ho
Address 15119 0
CPR Pharma Services Pty Ltd, Suite C, 32 West Thebarton Road, Thebarton, SA 5031
Country 15119 0
Australia
Phone 15119 0
+61 8 8125 1909
Fax 15119 0
+61 8 8354 3146
Email 15119 0
lien.ho@cprservices.com.au
Contact person for scientific queries
Name 6047 0
Mr Nuket Desem
Address 6047 0
South Yarra Corporate Centre, Suite T18, Level 1, 122 Toorak Road, South Yarra, Victoria 3141
Country 6047 0
Australia
Phone 6047 0
+61 3 9938 1205
Fax 6047 0
+61 3 9820 8262
Email 6047 0
nuket.desem@spinifexpharma.com.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary