A Phase 1, Adaptive, Single and Multiple Ascending Dose Study of EMA401 Sodium Salt Administered Orally in Healthy, Adult Males to Determine the Maximum Tolerated Dose and Pharmacokinetic Profiles

Phase 1

Completed

• Conditions: europathic Pain; Neuropathic Pain; Neurological - Other neurological disorders

• Registration Number: ACTRN12614000802606
• Lead Sponsor: Spinifex Pharmaceuticals Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-07-29
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 84

Inclusion Criteria

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 ECG and clinical laboratory determinations; Normotensive blood pressure (systolic blood pressure between 100 mmHg and 160 mmHg inclusive and diastolic blood pressure between 60 mmHg and 95 mmHg inclusive); No clinically relevant abnormality in an ECG; QTcF (QTc Fridericia’s correction) less than or equal to 450 ms, PR interval of 120-220 ms and a QRS duration less than or equal to 120 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 90 days after 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 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). If the subject’s partner is pregnant barrier contraception should be used to prevent potential exposure of the foetus to EMA401 in the ejaculate; 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; Subjects receiving medications (within the last 7 days prior to screening) that have the potential to prolong the QT interval or who may require such medications during the course of the study; Any condition that would interfere with drug absorption (e.g. chronic diarrhoea); Subjects with abnormal laboratory test results deemed clinically significant by the Medical Officer (Principal Investigator or medically qualified nominee) within 21 days before enrolment, including anaemia (haemoglobin less than 11.0 g/decilitre), neutropenia, thrombocytopenia, elevated liver function test results (AST and ALT) above the upper limit of normal and, serum potassium or magnesium concentrations outside of the normal range; Subjects with calcium concentrations greater than 10% outside of the normal range (this variation is to allow for artifactual results due to variations in sampling conditions); 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; Positive urine drug test or alcohol breath test.; Use of macrolide antibiotics (e.g. Erythromycin), azole antifungal agents (e.g. 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 including subjects with complete left bundle branch block (LBBB) 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 is equal to 300 mL beer, 1 glass wine, 1 measure spirit); Males who are unwilling to abide by the study restrictions listed in Section 8.3; Any subject who has previously enrolled in this or any clinical trial of EMA401; Any subject that would have difficulty swallowing multiple (up to 20) capsules of the study drug.

Study & Design

• Study Type: Interventional
• Study Design: Not specified