ACTRN12610000620022CompletedPhase 1
A Phase I Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of EMA401 Sodium Salt Administered Orally in Healthy Elderly Subjects
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 32
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 56 Years to o limit (—)
- Sex
- All
Inclusion Criteria
- •Males and post-menopausal females aged 56 years of age or older; 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; Systolic blood pressure between 90 mmHg and 160 mmHg inclusive; 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 less than or equal to 110ms; No clinically significant abnormal rhythm disturbance from a 48 hours pre-dose cardiac telemetry screen; resting pulse rate after sitting for 5 minutes greater than 45 beats per minute and less than 100 beats per minute; 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; A Body Mass Index between 18.5 kg/m2 and 32.0 kg/m2 inclusive; For males only - Agree to use two approved methods of contraception from Screening and until 30 days after administration of the investigational product; 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. This 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 35 days before enrollment; 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. Erhythromycin), 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 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 which in the opinion of the Principal Investigator 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 (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; 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; Any subject who has previously enrolled in this or any clinical trial of EMA401 Sodium Salt.
Investigators
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