None listed
Conditions
Brief summary
A multiple ascending dose study to determine the safety, tolerability and pharmacokinetics of EMA401 in healthy male volunteers aged 18-55
Interventions
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.
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 - 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.
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.
Outcome results
None listed