A Phase 1 Study to Evaluate a Tablet Formulation of PBT434 in Healthy Volunteers
- Conditions
- Multiple System AtrophyParkinson's diseaseNeurological - Neurodegenerative diseasesNeurological - Parkinson's disease
- Registration Number
- ACTRN12620001244998
- Lead Sponsor
- Alterity Therapeutics Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 42
1. Male or female between 18 and 65 years old (inclusive) (Parts I and II) or 18-75 years old (Part III) at the time of consent.
Note: Part III will include at least 4 subjects =50 years old
2. In good general health, free from clinically significant medical or psychiatric illness
based on medical/surgical history, physical examination, 12-lead ECG, and clinical laboratory tests
3. Vital signs within ranges and stable (measured in supine position after 5 minutes rest)
4. Body Mass Index greater than or equal to 18kg/m2 and less than or equal to 30 kg/m2
5. Adequate venous access in the left or right arm to allow collection of the required number of blood samples
6. Provides written informed consent
7. Willing to comply with all study procedures and requirements, including consumption of a standardized high-fat, high calorie meal
8. Women of childbearing potential are using two acceptable methods of contraception through 90 days after the final dose
9. Male subjects must be using an acceptable birth control method through 90 days after the final dose
10. Female subjects must agree to not donate ova for 90 days after the final dose. Male subjects must agree to not donate sperm for 90 days after the final dose
11. No significant changes to diet within the 30 days prior to dosing through study completion
12. Willing and able to abstain from caffeine from 48 hours prior to check-in through 48 hours after dosing in each study period
1. Women who are pregnant or breastfeeding
2. History or presence of malignancy, with the exception of adequately treated localized skin cancer (basal cell or squamous cell carcinoma) or carcinoma in-situ of the cervix, which are allowed
3. Evidence of any clinically relevant medical illness, including cardiovascular, hematological, gastrointestinal, hepatic, renal, rheumatologic, endocrine, pulmonary, neurologic, psychiatric or skin disorders
4. Clinically significant surgical procedure within 3 months prior to screening or anticipated surgery during the study
5. History of epilepsy (other than febrile seizures during childhood)
6. History of head trauma with loss of consciousness, amnesia or skull fracture
7. Currently suffers from clinically significant systemic allergic disease or has a history of significant drug allergies including a history of anaphylactic reaction; allergic reaction due to any drug which led to significant morbidity
8. Unable to swallow study medication
9. History or presence of cardiac arrhythmia or congenital long QT syndrome
10. QTcF >450 msec for men or >470 msec for women on screening or baseline ECG
11. Use of any tobacco or nicotine containing products (including social use) in the 3 months prior to dosing or a positive urine cotinine test prior to dosing
12. Regular alcohol consumption >2 units/day (1 unit = 250 mL of beer, 100 mL of wine, or 30 mL of distilled spirits or liquor) or alcohol consumption within 24 hours prior to dosing until study completion
13. Positive urine drug or alcohol breathalyzer test prior to study entry (during screening or Day -1) or during the study, or history of alcohol or drug abuse in the 12 months prior to dosing
14. Evidence of renal insufficiency, as indicated by an estimated creatinine clearance <90 mL/min using the Cockcroft-Gault equation
15. Any of the following abnormalities in liver enzymes at Screening or Baseline:
a. Aspartate transaminase (AST) or alanine aminotransferase (ALT) >1.5 times the upper limit of normal (ULN)
b. Alkaline phosphatase (ALP) or total bilirubin (TBil) >2 times the ULN
16. Hemoglobin value less than the lower limit of normal
17. Positive results of serology screening for hepatitis B (hepatitis B surface antigen [HBsAg]), hepatitis C (anti-hepatitis C virus [HCV] antibodies) or HIV (HIV antibodies type 1 and 2)
18. Any acute illness, clinically significant infection or clinically significant abnormal laboratory result within 28 days prior to dosing
19. Use of any prescription medication within 28 days prior to dosing
20. Use of any non-prescription medication (including non-steroidal anti-inflammatory drugs), herbal remedy (including St. John’s Wort) or vitamin supplement, within 14 days prior to dosing and throughout the study
Note: Approved doses of paracetamol (acetaminophen, up to a maximum of 2,000 mg/day) may be permitted during Screening and while on study at the investigator’s discretion.
21. Use of an investigational drug or device within 28 days or 10 half-lives of the drug, whichever is longer, prior to start of dosing (or within 6 months prior to Day -1 if investigational drug was a biologic)
22. Clinically significant blood loss or blood or plasma donation >550 mL within 90 days prior to start of dosing
23. As a result of history and physical examination, the Investigator considers the subject unfit for the study
24. Any condition (e.g., chronic diarrhea,
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method