A Phase I, Open-Label, Twice Daily Dose, Pharmacokinetic Study of EMA401 Sodium Salt Administered Orally in Healthy Elderly Subjects

Phase 1

Completed

• Conditions: Postherpetic Neuralgia; Neurological - Other neurological disorders

• Registration Number: ACTRN12610000961044
• Lead Sponsor: Spinifex Pharmaceuticals Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-11-09
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

Males and post-menopausal females aged 56 years of age or older; Healthy subjects, 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; Systolic blood pressure between 90 mmHg and 160 mmHg inclusive and Diastolic blood pressure less than or equal to 90 mmHg; 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 of less than or equal to 110 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; For males only: Agrees to use two approved methods of contraception from Screening and until 30 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 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.

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 and includes the taking of permitted medications that have not been stable in dosage and regimen for a minimum of 3 months prior to the first day 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 within 28 days before 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; 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 55 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) which in the opinion of the Principal Investigator (or medically qualified nominee) would compromise the participant’s safety or other aspects of the study; 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; 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; Subjects who have received blood or blood products within 90 days before the first dose administration; Subjects who regularly drink more than four (4) units (males) or more than two (2) units (females) of alcohol daily (1 unit = 300 mL beer, 1 glass wine, 1 measure spirit); Subjects who are unwilling to abide by the study restrictions.

Study & Design

• Study Type: Interventional
• Study Design: Not specified