None listed
Conditions
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.
Interventions
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.
Sponsors
Spinifex Pharmaceuticals Pty Ltd.
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
Male
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
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.
Outcome results
None listed