A Randomised, Double-Blind and Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SIR9900 after Oral Administrations in Healthy Elderly Volunteers. (Multiple Ascending Dose (MAD), Part 2 Cohort 5).
- Conditions
- Inflammatory diseases, particularly in central nervous systemDegenerative diseases, particularly in central nervous systemInflammatory and Immune System - Other inflammatory or immune system disordersNeurological - Neurodegenerative diseases
- Registration Number
- ACTRN12623000790640
- Lead Sponsor
- Sironax Aus Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 8
Potential participants must fulfil all the following inclusion criteria to be eligible for the study:
1. Are capable of signing the Participant Informed Consent Form (PICF) and complying with study procedures.
2. Male or female participants aged greater than or equal to 65 years old who are healthy or have managed, stabilised disease in the opinion of the Investigator for the healthy elderly volunteer cohort in Part 2 (MAD) only.
3. Women of childbearing potential (WOCBP) must agree to practice a double method of contraception of a medically acceptable method of contraception with an annual failure rate of less than 1% with a barrier contraceptive (such as condom) during the study and for 30 days after discontinuation of study treatment. Unless she is exclusively in same-sex relationships. Women are considered not of childbearing potential if they are surgically sterile (i.e., hysterectomy, bilateral oophorectomy, or bilateral salpingectomy) or > 1 year postmenopausal.
4. All male participants with female partners of childbearing potential must agree to practice a double method of contraception of a medically acceptable method of contraception with an annual failure rate of less than 1% with a barrier contraceptive (such as condom), and must agree to abstain from sperm donation during and for 90 days after participation in the study. Unless he is exclusively in same-sex relationships.
5. Considered healthy by the Principal Investigator (PI) or delegate, based on a detailed medical history, full physical examination, clinical laboratory tests, 12-lead ECG and vital signs.
6. Non-smoker/Social smoker, defined as not having smoked more than 5 cigarettes or equivalent per day in the last 3 months before screening. During screening till the end of the confinement period, participant must be able to and must agree to abstain from the use of nicotine/tobacco containing products. Positive result of cotinine screen at admission will be excluded.
7. Able to abstain from the consumption of alcohol and any alcohol-containing products from 48 hours before dosing to the end of the confinement period
8. Able to abstain from the consumption of coffee and any caffeine-containing products from 48 hours before dosing to the end of the confinement period.
9. Body mass index (BMI) of 18 to 30 kg/m2 inclusive and body weight not less than 50 kg.
10. Willing and able to adhere to study restrictions and to be confined at the clinical research unit.
Potential participants will be excluded from study entry if any of the following exclusion criteria are present at screening or admission:
1. Clinically significant haematological findings at screening.
2. Abnormal findings indicating hepatic impairment, such as aspartate transaminase (AST), alanine transaminase (ALT), or alkaline phosphatase greater than or equal to 1.5 times upper limit of normal (ULN), total bilirubin > ULN, albumin less than or equal to 3 g/dL, serum amylase or lipase greater than or equal to 1.5 times ULN at screening.
3. Abnormal findings indicating renal impairment, such as creatinine greater than or equal to 1.5 times ULN, estimated glomerular filtration rate of 80 mL/minute or less calculated by the Cockcroft-Gault formula, at screening.
4. Clinically significant ECG findings including QTcF value > 450 ms for male or > 470 ms for female at screening/pre-dose day 1.
5. Participants with a mean systolic blood pressure (SBP) of three measurements >140 mmHg, or a mean diastolic blood pressure (DBP) of three measurements > 90 mmHg at screening. Blood pressure will be measured at sitting position at screening.
6. Positive blood screen for human immunodeficiency virus (HIV), or hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV), or syphilis at screening or at any time during the screening period pre-dose.
7. A history of seizure. However, a history of febrile seizure is allowed.
8. Positive results of pregnancy test at screening or admission. Pregnant or breast feeding, or planning to become pregnant, breast feed or donate ova during the study and within 30 days after the study.
9. A hospital admission or major surgery within 60 days prior to screening and/or planned surgery for the duration of the study and follow up period.
10. Receipt of any other investigational drug product within 30 days or 5 half-lives of the other investigational drug (whichever is longer) prior to dosing.
11. Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, (DSM-V) substance use disorders and alcohol abuse within 12 months prior to screening and/or positive alcohol breath test at screening or admission.
12. A positive result for drugs of abuse at screening or admission. One repeat test will be allowed if false positive is considered by the PI or designee.
13. An unwillingness or inability to comply with food and beverage restrictions during study participation, including consumption of grapefruit (or pomelo or start fruit) or grapefruit juice, Seville oranges, Seville orange marmalade or other products containing grapefruit, pomelo, star fruit or Seville oranges within 7 days before dosing and until final discharge from the CRU.
14. Donation or blood collection of more than 1 unit (approximately 450 mL) of blood (or blood products) or acute loss of blood during the 30 days prior to screening and/or planning to donate blood during the study and follow up period.
15. Continued stable use within three months prior to screening of prescription and non-prescription medications, vitamins, and supplements that are not potential index substrates for CYP450 isoform 1A2, or inhibitor/inducers of isoforms 3A4 or 2C8 enzymes, and are used to manage and stabilise existing conditions or diseases are permitted at the discretion of the Investigator. The following is not permitted prior to dosing: use of prescription medicines or other products that are potential index substrates for CYP450 isoform 1A2, or inhi
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method