None listed
Conditions
Brief summary
This research project is being conducted to look at the safety, tolerability, pharmacokinetics (PK, how the human body processes a substance) and pharmacodynamics (PD, how the human body interacts with a substance) of SIR1-365 when given to healthy volunteers as a single oral dose or as multiple oral doses for up to 10 consecutive days.
Interventions
Part 1 includes 5 dosing cohorts with 8 subjects in each cohort, 6 subjects to be treated with SIR1-365 and 2 subjects with placebo. Two subjects to be enrolled in each of the 5 dosing cohorts will be treated first (one subject with SIR1-365 and another subject with matching placebo). If there is no significant safety concern within 48 hours after dosing in those two subjects, the rest of the subjects in the dose cohort will then be treated at the same time with a single oral dose of either plac
Part 1 includes 5 dosing cohorts with 8 subjects in each cohort, 6 subjects to be treated with SIR1-365 and 2 subjects with placebo. Two subjects to be enrolled in each of the 5 dosing cohorts will be treated first (one subject with SIR1-365 and another subject with matching placebo). If there is no significant safety concern within 48 hours after dosing in those two subjects, the rest of the subjects in the dose cohort will then be treated at the same time with a single oral dose of either placebo or SIR1-365. Subjects in cohorts 1-5 will receive a single 10mg, 30mg, 100mg, 200mg or 300mg oral dose of SIR1-365 or placebo instead of SIR1-365. Dose escalation will not occur until a decision is made by the Safety Review Committee based on the review of safety and tolerability data from the previous dose cohort. Each subject will remain in the study unit for 5 days. Part 2 will include 3 dosing cohorts with 10 subjects in each cohort. Eight subjects will be treated with SIR1-365 and two subjects with placebo in each cohort. Subjects enrolled in the Part 2 2nd cohort, will have one CSF sample collected during Days 5-9. The three doses for Part 2 will be decided after the completion of Part 1. The potential dose range for Part 2 is 10-300mg. Each subject will receive oral administrations of either placebo or SIR1-365 to be administered twice daily for 10 days. Each subject will remain in the study unit for 14 days. All Part 1 and Part 2 subjects will complete 1 additional outpatient visit for safety assessment. Study staff will instruct subjects to take the study medication exactly as instructed as compliance is necessary for subject safety and for the validity of the study.
Sponsors
Sironax Aus Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Are capable of signing informed consent form (ICF) and complying with study procedures; 2. Women of childbearing potential (WOCBP) must have a negative pregnancy test and be practicing a medically acceptable method of contraception. All male patients with female partners of child-bearing potential must use two acceptable methods of contraception, during and for 3 months after participation in the study. 3. Nonsmoker, defined as not having smoked more than 2 cigarettes a day during the 6 months before screening. During the study, subject should be able to limit the use of tobacco products to 2 cigarettes a day; 4. Able to abstain from the consumption of alcohol and any alcohol-containing products from 48 hours before dosing through the end of the study; 5. Able to limit the consumption of coffee and any caffeine-containing products to four cups a day during the study; 6. Body mass index (BMI) of 18 to 32 kg/m2 inclusive and body weight not less than 50 kg;
Exclusion criteria
1. Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity 2. Clinically significant findings of screening clinical safety laboratory tests 3. Subjects with a mean systolic blood pressure of three measurements >150 mmHg, or a mean diastolic blood pressure of three measurements >90 mmHg at screening. Blood pressure will be measured at sitting position 4. Known or suspected malignancy, except adequately treated basal cell carcinoma 5. Positive blood screen for human immunodeficiency virus (HIV), or hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) 6. A history of seizure. However, a history of febrile seizure is allowed 7. A hospital admission or major surgery within 60 days prior to screening 8. Participation in any other investigational drug trial within 30 days prior to screening 9. DSM-V substance use disorders within 6 months prior to screening 10. A positive result for alcohol or drugs of abuse at screening or admission. 11. Donation or blood collection of more than 1 unit (approximate 450 mL) of blood (or blood products) or acute loss of blood during the 30 days prior to screening 12. Use of prescription or over-the-counter (OTC) medications, and herbal medicines within 30 days prior to dosing 13. A history of suicide attempt in the past 12 months and/or seen by the investigator as having a significant history of risk of suicide or homicide
Outcome results
None listed