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Trial registered on ANZCTR


Registration number
ACTRN12610000620022
Ethics application status
Approved
Date submitted
25/07/2010
Date registered
29/07/2010
Date last updated
24/08/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Phase I Multiple Ascending Dose Study of EMA401 Sodium Salt Administered Orally in Healthy Elderly Subjects
Scientific title
A Phase I Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of EMA401 Sodium Salt Administered Orally in Healthy Elderly Subjects
Secondary ID [1] 252294 0
EMA401-002, Spinifex Pharmaceuticals Pty Ltd
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postherpetic Neuralgia 257811 0
Condition category
Condition code
Neurological 257981 257981 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
EMA401 Sodium Salt administered orally once daily for 7 days. The starting dose level is 50 mg for 7 days (Cohort 1) with provision to escalate to 100 mg for 7 days (Cohort 2) subject to Data Safety Monitoring Committee (DSMC) review.
Intervention code [1] 256872 0
Treatment: Drugs
Comparator / control treatment
Placebo comparator - Lactose monohydrate hand-filled into hard VCaps Plus (Registered Trademark) capsules. Within each dose level 8 subjects will be randomised to receive active EMA401 Sodium Salt and 8 will be randomised to receive placebo.
Control group
Placebo

Outcomes
Primary outcome [1] 258846 0
To evaluate the safety and tolerability of a single dose of EMA401 Sodium Salt administered once daily for seven consecutive days in a healthy elderly population.
Timepoint [1] 258846 0
EMA401 Sodium Salt will be administered for seven consecutive days, followed by monitoring for 48 hours. Subjects will then be discharged on Day 9 with follow-up on Days 11, 13 and 15, and an exit visit on Day 17. During this time vital signs, physical examination, clinical laboratory determinations, 12 lead electrocardiogram (ECG) reading and continuous (whilst in-clinic) five lead telemetry will be performed. All subjects will be monitored for adverse events (eg. nausea, dizziness, fatigue etc.) and concomitant medications for the duration of the study and all information received between consent and final visit (Day 17) will be recorded in the case report form.
Secondary outcome [1] 264963 0
To determine the pharmacokinetic profile of EMA401 Sodium Salt following administration of a daily dose of EMA401 for seven consecutive days.
Timepoint [1] 264963 0
A total of thirty-three (33) pharmacokinetic (PK) blood samples will be collected including five (5) pre-dose samples, one sample to be collected on each of Days 1, 4, 5, 6 and 7; thirteen (13) samples post-Day 1 dosing at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 16 and 24 hours post-dose; and fifteen (15) samples post-Day 7 dosing at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose.

Eligibility
Key inclusion criteria
Males and post-menopausal females aged 56 years of age or older; 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 ECG and clinical laboratory determinations; Systolic blood pressure between 90 mmHg and 160 mmHg inclusive; 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 less than or equal to 110ms; No clinically significant abnormal rhythm disturbance from a 48 hours pre-dose cardiac telemetry screen; resting pulse rate after sitting for 5 minutes greater than 45 beats per minute and less than 100 beats per minute; 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; A Body Mass Index between 18.5 kg/m2 and 32.0 kg/m2 inclusive; For males only - Agree to use two approved methods of contraception from Screening and until 30 days after administration of the investigational product; Have given written informed consent to participate in this study in accordance with local regulations.
Minimum age
56 Years
Maximum age
No limit
Sex
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. This 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 35 days before enrollment; 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. Erhythromycin), 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 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 which in the opinion of the Principal Investigator 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 (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; 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; 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 -2. The randomisation schedule will be maintained under controlled access and sealed subject-specific code break envelopes will be kept at the clinical study site in a secure, accessible location.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule will be created using computer-generated block randomisation, stratified equally to males and females.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
25/07/2010
Actual
14/07/2010
Date of last participant enrolment
Anticipated
Actual
21/10/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
32
Accrual to date
Final
32
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257332 0
Commercial sector/Industry
Name [1] 257332 0
Spinifex Pharmaceuticals Pty Ltd
Country [1] 257332 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] 256575 0
None
Name [1] 256575 0
Address [1] 256575 0
Country [1] 256575 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259358 0
Bellberry Limited
Ethics committee address [1] 259358 0
Ethics committee country [1] 259358 0
Date submitted for ethics approval [1] 259358 0
Approval date [1] 259358 0
30/06/2010
Ethics approval number [1] 259358 0

Summary
Brief summary
This study is designed to assess the safety, tolerability and pharmacokinetic profile of seven (7) consecutive daily doses of EMA401 Sodium Salt in an elderly population (aged 56 years and over) at dose levels of 50 and 100 mg.
Trial website
Trial related presentations / publications
Not applicable
Public notes

Contacts
Principal investigator
Name 31432 0
Dr Sepehr Shakib
Address 31432 0
CMAX (A Division of IDT Australia Ltd)
Level 5, East Wing
Royal Adelaide Hospital, North Terrace
Adelaide, SA 5000
Country 31432 0
Australia
Phone 31432 0
+61 8 8222 3923
Fax 31432 0
Email 31432 0
Sepehr.Shakib@health.sa.gov.au
Contact person for public queries
Name 14679 0
Lien Ho
Address 14679 0
CPR Pharma Services Pty Ltd
Suite C
32 West Thebarton Road
Thebarton, SA 5031
Country 14679 0
Australia
Phone 14679 0
+61 8 8125 1909
Fax 14679 0
Email 14679 0
lien.ho@cprservices.com.au
Contact person for scientific queries
Name 5607 0
Lien Ho
Address 5607 0
CPR Pharma Services Pty Ltd
Suite C
32 West Thebarton Road
Thebarton, SA 5031
Country 5607 0
Australia
Phone 5607 0
+61 8 8125 1909
Fax 5607 0
Email 5607 0
lien.ho@cprservices.com.au

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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