A Phase I, Randomised, Open-Label, Three-way Crossover Comparative Pharmacokinetic Study of EMA401 Sodium Salt When Administered Orally in Fed (high fat meal or orange juice only) and Fasted Healthy Adult Males.
- Conditions
- Postherpetic NeuralgiaNeurological - Other neurological disorders
- Registration Number
- ACTRN12610000798066
- Lead Sponsor
- Spinifex Pharmaceuticals Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 15
Male and aged between 18 and 55 years (inclusive); 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 Electrocardiogram (ECG) and clinical laboratory determinations; Normotensive (systolic blood pressure between 90 mmHg and 140 mmHg inclusive and diastolic blood pressure between 60 mmHg and 90 mmHg inclusive); 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 100 ms; Semi-supine pulse rate after resting 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 adhere to dietary requirements; Agrees to use two approved methods of contraception from Screening and until 30 days after last drug administration of the study drug. Agreed methods of contraception may include condom, use of approved birth control pills, patches, implants or injections by the subject’s partner, use of diaphragm with vaginal spermacide by the subject’s partner, use of an IUD (intra uterine device) by the subject’s partner and/or surgical sterilization (vasectomy at least six months prior to dosing); Have given written informed consent to participate in this study in accordance with local regulations.
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 by the Medical Officer (Principal Investigator or medically qualified nominee) within 21 days of enrolment, including anaemia (haemoglobin less than 110 g/L), neutropenia, thrombocytopenia and elevated liver function test results (Aspartate transaminase (AST) and Alanine transaminase (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 which, in the opinion of the Principal Investigator (or medically qualified nominee) 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 (e.g. personal history or family history of syncope, long QT syndrome or sudden death); 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; Males who regularly drink more than four (4) units of alcohol daily (1 unit = 300 mL beer, 1 glass wine, 1 measure spirit); Males 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
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the effects of food on the pharmacokinetics of EMA401 after a single oral dose of EMA401 Sodium Salt, comparing dose administration following a high fat meal or with orange juice against dose administration in the fasted state, in healthy adult males.[In each of the 3 treatment periods, blood samples for pharmacokinetic analysis will be taken at pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose following each dose administration (18 samples in each period, 54 samples in total).]
- Secondary Outcome Measures
Name Time Method il[Nil]