Tolerability and Safety of Nano-Tocotrienols

Korábbi kezelés

• Receiving other investigational drugs and vitamin E
• Existing ischaemic heart disease, symptomatic heart failure, stroke or peripheral arterial disease/amputation and/or uncontrolled concurrent illness within three (3 months) of study randomization
• Current or prior history of either HIV, Hepatitis B, or Hepatitis C infection
• Recent participation (within 28 days or 10 half-lives of the drug before dosing, whichever is longer) in other clinical study involving a marketed or investigational drug
• Patients who are unable or unwilling to take Tocotrienols, herbal remedies, or non-prescription medications
• History of alcohol intake (≥ 14 units per week) within 6 months before dosing (1 unit of alcohol equals approximately ½ pint [285 mL] of beer, 1 glass [125 mL] of wine, or 1 shot [25 mL] of spirit).

Más betegség

• A history of significant adverse reactions or allergies to any medications.
• Active cancer in the last 5 years

Laborértékek

• Transaminitis defined by a raised ALT or AST >3 times upper limit normal
• Chronic kidney disease defined by either an estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m2 or urinary albumin:creatinine ratio >3 mg/mmol with two (2) samples for three (3) consecutive months
• Clinically significant medical history, physical examination findings or laboratory abnormalities at the investigators' discretion.

Egyéb

• Currently pregnant or on breast feeding
• Smoker ≥ 10 sticks of cigarettes a day, vape ≥ 20 mg of liquid nicotine a day, or equivalent.

• Adults ≥18 yrs old ≤60 yrs old (inclusive)
• Weight within the BMI of 18-35 kg/m2 (inclusive)
• Be willing and able to participate in all scheduled visits including follow-up, treatment plan, laboratory tests and other study procedures according to clinical protocol
• Able to provide written informed consent