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Trial registered on ANZCTR


Registration number
ACTRN12609000489291
Ethics application status
Approved
Date submitted
24/03/2009
Date registered
18/06/2009
Date last updated
19/10/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
A phase I, randomised, double-blind, placebo controlled, dose ranging study to evaluate the safety, tolerability and pharmacokinetics of EMA401 following multiple oral dosing in healthy male subjects.
Scientific title
A phase I, randomised, double-blind, placebo controlled, dose ranging study to evaluate the safety, tolerability and pharmacokinetics of EMA401 following multiple oral dosing in healthy male subjects.
Secondary ID [1] 252295 0
EMA401-001C. Spinifex Pharmaceuticals Pty Ltd
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postherpetic Neuralgia 4525 0
Condition category
Condition code
Neurological 4813 4813 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
EMA401 powder hand-filled into hard VCaps Plus (Registered Trademark) capsules. 8 subjects in each cohort group will take a single oral dose of the EMA401 for seven consecutive days. There are 3 cohort groups with dose levels of 10 mg (Group 1), 25 mg (Group 2) and 50 mg (Group 3). There will be 12 subjects per cohort group, 4 receiving placebo and 8 receiving the active drug.
Intervention code [1] 4284 0
Treatment: Drugs
Comparator / control treatment
Placebo - Lactose monohydrate hand-filled into hard VCaps Plus (Registered Trademark) capsules. 4 out of 12 subjects in each of the three cohort groups will take a single oral dose of the placebo for seven consecutive days.
Control group
Placebo

Outcomes
Primary outcome [1] 5672 0
To evaluate the safety and tolerability of a single dose of EMA401 administered for seven consecutive days.
Timepoint [1] 5672 0
EMA401 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) readings and continuous (whilst in-clinic) six lead telemetry will be performed. All subjects will be monitored for adverse events 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] 241562 0
To determine the pharmacokinetic profile of EMA401 following administration of a daily dose of EMA401 for seven consecutive days.
Timepoint [1] 241562 0
Pharmacokinetic (PK) blood samples will be collected pre-dose and post-dose.

Eligibility
Key inclusion criteria
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. Normotensive [systolic BP (blood pressure) between 90mmHg & 140 mmHg and diastolic BP between 60 mmHg & 90 mmHg]. No clinically relevant abnormality in an ECG; QTcF (QTc Fridericia’s correction) =450 ms, PR interval of 120-210 ms and a QRS duration = 100 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; Agrees to use two approved methods of contraception from Screening and until 30 days after administration of the study drug; 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 within 21 days before enrolment including anaemia (haemoglobin less than 11.0 g/decilitre), neutropenia, thrombocytopenia and elevated liver function test results [including aspartate transaminase (AST) and alanine aminotransferase (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. History of epilepsy. History or clinical evidence of significant cardiovascular disease. 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 and 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). Any subject who has previously enrolled in this or any clinical trial of EMA401.

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 a sequentially numbered randomisation number following confirmation of eligibility on day minus 1 (the day before dosing) and the screening visit results. The randomisation number will be matched to the treatment allocation from a randomisation schedule which is computer generated and maintained under controlled access. The subject and all clinical staff will be blinded to the treatment allocation. Only the unblinded staff members involved in the drug dispensing will be aware of the treatment allocation. Emergency codebreak envelopes are stored securely at the site should an emergency situation require the knowledge of what treatment the subject received.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated block randomisation per cohort.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Dose escalation study with multiple dosing at each level. 3 Dose levels.
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/04/2009
Actual
6/04/2009
Date of last participant enrolment
Anticipated
Actual
25/09/2009
Date of last data collection
Anticipated
Actual
Sample size
Target
36
Accrual to date
Final
96
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4713 0
Commercial sector/Industry
Name [1] 4713 0
Spinifex Pharmaceuticals Pty Ltd
Country [1] 4713 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Spinifex Pharmaceuticals Pty Ltd
Address
PO Box 2210
Wattletree Road LPO
Malvern East
3145 VIC
Country
Australia
Secondary sponsor category [1] 4259 0
None
Name [1] 4259 0
Address [1] 4259 0
Country [1] 4259 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239272 0
Bellberry Limited
Ethics committee address [1] 239272 0
229 Greenhill Road
Dulwich SA 5065
Ethics committee country [1] 239272 0
Australia
Date submitted for ethics approval [1] 239272 0
Approval date [1] 239272 0
06/04/2009
Ethics approval number [1] 239272 0
B46/09

Summary
Brief summary
A multiple ascending dose study to determine the safety, tolerability and pharmacokinetics of EMA401 in healthy male volunteers aged 18-55
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29433 0
Dr Sepehr Shakib
Address 29433 0
CMAX
Level 5, East Wing
Royal Adelaide Hospital, North Terrace
Adelaide, SA 5000
Country 29433 0
Australia
Phone 29433 0
61 8 8222 3923
Fax 29433 0
Email 29433 0
[email protected]
Contact person for public queries
Name 12680 0
Ms Tamara Murdock
Address 12680 0
Centre for Pharmaceutical Research
GPO Box 2471
Adelaide
South Australia
5001
Country 12680 0
Australia
Phone 12680 0
+61 8 8302 1392
Fax 12680 0
Email 12680 0
[email protected]
Contact person for scientific queries
Name 3608 0
Ms Tamara Murdock
Address 3608 0
Centre for Pharmaceutical Research
GPO Box 2471
Adelaide
South Australia
5001
Country 3608 0
Australia
Phone 3608 0
+61 8 8302 1392
Fax 3608 0
Email 3608 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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