Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000335392
Ethics application status
Approved
Date submitted
18/06/2008
Date registered
16/07/2008
Date last updated
18/06/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Phase I, Randomized, Double-Blind, Placebo-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of EMA401 Following Single Ascending Oral Dosing of EMA401.Na in Healthy Volunteers Administered Orally in the Fasted and Fed State.
Scientific title
A Phase I, Randomized, Double-Blind, Placebo-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of EMA401 Following Single Ascending Oral Dosing of EMA401.Na in Healthy Volunteers Administered Orally in the Fasted and Fed State.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postherpetic Neuralgia 3276 0
Condition category
Condition code
Neurological 3556 3556 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
EMA401 powder hand-filled into hard gelatin capsules.
4 out of 6 subjects in each cohort will take a single oral dose of the EMA401 following an overnight fast. There are 6 cohorts with dose levels of 100mg, 200mg, 400mg, 600mg, 800mg, 1000mg. One dose level (cohort) will be asked to return to repeat the study with the drug being taken following a standard meal. There will be 6 subjects per cohort, 2 receiving placebo and 4 receiving the active drug.
Intervention code [1] 3017 0
Treatment: Drugs
Comparator / control treatment
Placebo - Lactose monohydrate hand-filled into hard gelatin capsules.
2 out of 6 subjects in each cohort will take a single oral dose of the placebo following an overnight fast. There are 6 cohorts with dose levels for the active drug of 100mg, 200mg, 400mg, 600mg, 800mg, 1000mg. One dose level (cohort) will be asked to return to repeat the study with the drug being taken following a standard meal. There will be 6 subjects per cohort, 2 receiving placebo and 4 receiving the active drug.
Control group
Placebo

Outcomes
Primary outcome [1] 4335 0
To evaluate the safety and tolerability of a single dose of EMA401
Timepoint [1] 4335 0
Vital signs (x10), clinical laboratory results(x6) and Electrocardiograms (ECGs) (x12) will be recorded over a 48 hour time period post dose and 24 hour cardiac telemetry for the first 24 hours post-dose. Vital signs measurements include resting heart rate, Blood Pressure readings, respiratory rate and body temperature recording. The clinical laboratory results will be from blood samples taken at the screening visit, the day prior to dosing, at 4, 24 and 48 hours post-dose and again at the follow up visit, 7 days post-dose. Adverse events and concomitant medications required will be monitored over the 48 hour time period post dose. A final follow up evaluation including a physical examination will be performed 7 days post dose.
Secondary outcome [1] 7307 0
To determine the pharmacokinetic profile of EMA401 following a single oral dose in healthy fasting volunteers.
Timepoint [1] 7307 0
1 x pre-dose and 18 post-dose blood samples will be collected over a 48 hour period. Urine will be collected for 24 hours post-dose. Both blood and urine samples will be analysed to profile the pharmacokinetics.
Secondary outcome [2] 7308 0
To determine the effects of food on the pharmacokinetics of EMA401 following a single oral dose in healthy volunteers.
Timepoint [2] 7308 0
Dosing will be repeated in one dose level, with dosing occurring after a standard meal. 1 x pre-dose and 18 post-dose blood samples will be collected over a 48 hour period. Urine will be collected for 24 hours post-dose. Both blood and urine samples will be analysed to profile the food-effect pharmacokinetics.

Eligibility
Key inclusion criteria
Healthy subjects- defined as individuals who are free from clinically significant illnesss or disease as determined by their medical / surgical history, physical examination (including height & weight), 12 lead electrocardiogram (ECG) and clincial laboratory determinations.
Normotensive - Systolic between 90 and 140 mmHg, diastolic between 60 & 90 mmHg.
No clincially relevant abnormality in an electrocardiogram (ECG) - QTc < 450ms, PR interval 120-210 ms, QRS duration <100ms. (QTc = QT interval corrected for heart rate, where QT = a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle, PR interval = measured from the beginning of the P wave to the beginning of the QRS complex and QRS duration (complex) = a structure on the ECG that corresponds to the depolarization of the ventricles.
Resting pulse rate - between 40 and 100 bpm
Body Mass Index (BMI)- between 19 and 30 kg/m2
Human Immunodefeciency Virus (HIV), Hepatitis B virus and Hepatitis C virus negative
Smoked less than 5 cigarettes or equivalent per month in last 12 months.
Agrees to use 2 methods of contraception during study.
Minimum age
18 Years
Maximum age
55 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Has received / anticipates receiving a new prescription systemic / topical mediction within 14 days prior to dosing.
Any disease interfering with drug absorption.
Any abnormal clincial laboratory findings deemed significant by the Medical Officer.
Positive urine drug test /alcohol breath test
History of coronary /cardiovascular/ cerebrovsacular disease, uncontrolled hypertension
Any acute therapy for a serious infection within 30 days of study entry.
Blood donation greater than 550mL within 90 days of dosing.
participation in a clinical trial /received experimental therapy within 30 days of dosing.
Consumption of grapefruit juice/products within 14 days prior to study confinement.
Unwilling to provide consent.

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 -1 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)
Randomisation computer generated block randomisation per cohort.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Dose escalation with single dosing per dose level -6 dose levels + one dose level is repeated for the food effect cohort.
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/07/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3492 0
Commercial sector/Industry
Name [1] 3492 0
Spinifex Pharmaceuticals Pty Ltd.
Country [1] 3492 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Spinifex Pharmaceuticals Pty Ltd.
Address
PO Box 2210, Wattletree Road LPO
Malvern East, Victoria,
3145
Country
Australia
Secondary sponsor category [1] 3135 0
None
Name [1] 3135 0
Address [1] 3135 0
Country [1] 3135 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5529 0
The Alfred Research Ethics Committee
Ethics committee address [1] 5529 0
Ethics committee country [1] 5529 0
Australia
Date submitted for ethics approval [1] 5529 0
04/06/2008
Approval date [1] 5529 0
Ethics approval number [1] 5529 0

Summary
Brief summary
This study is to evaluate the pharmacokinetics (the way the body absorbs the drug) and to determine what the safest that can be used.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28676 0
Address 28676 0
Country 28676 0
Phone 28676 0
Fax 28676 0
Email 28676 0
Contact person for public queries
Name 11833 0
Tamara Murdock
Address 11833 0
Centre for Pharmaceutical Research
University of South Australia
Level 4 Reid Building
Frome Road, Adelaide
SA 5000
Country 11833 0
Australia
Phone 11833 0
0061 8 8302 2311
Fax 11833 0
Email 11833 0
[email protected]
Contact person for scientific queries
Name 2761 0
Tamara Murdock
Address 2761 0
Centre for Pharmaceutical Research
University of South Australia
Level 4 Reid Building
Frome Road, Adelaide
SA 5000
Country 2761 0
Australia
Phone 2761 0
0061 8 8302 2311
Fax 2761 0
Email 2761 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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