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.
- Conditions
- Postherpetic NeuralgiaNeurological - Other neurological disorders
- Registration Number
- ACTRN12608000335392
- Lead Sponsor
- Spinifex Pharmaceuticals Pty Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 36
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.
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
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the safety and tolerability of a single dose of EMA401[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 Measures
Name Time Method To determine the pharmacokinetic profile of EMA401 following a single oral dose in healthy fasting volunteers.[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.];To determine the effects of food on the pharmacokinetics of EMA401 following a single oral dose in healthy volunteers.[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.]