A Phase I Dose-Escalation Study of the Safety and Pharmacokinetics of Vitamin E δ-Tocotrienol Following Multiple Dose Administration in Healthy Subjects

Inclusion Criteria:

- Equal to or greater than 18 years of age

- Eastern Cooperative Oncology Group (ECOG) performance status of ≤2

- Adequate organ function:

- Serum creatinine ≤1.5 mg/dL or calculated creatinine clearance ≥60 mL/min.

- Bilirubin ≤ the intuitional upper limits of normal

- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) to be within
institutional normal range

- Absolute neutrophil count (ANC) ≥1000mm³

- Platelet count ≥100,000mm³

- Has the capability of understanding the informed consent document and has signed the
informed consent document

- Sexually active participants (male and female) must use medically acceptable methods
of contraception during the course of the study.

- Women of childbearing potential must have a negative pregnancy test at screening.

- Able to understand and comply with the requirements of the protocol

Exclusion Criteria:

- receiving investigational therapy (other than the investigational therapy under
study)

- Have received investigational therapy within 30 days prior to first dose of study
drug

- Patients who are unable to swallow capsules

- Patients with prior malignancies, other than squamous or basal cell carcinomas,
unless disease free for ≥ 5 years

- Have had prior major surgery within 30 days prior to first dose of study drug

- The patient has active infection or fever >38.5C within 3 days prior to first dose of
study drug.

- Have uncontrolled intercurrent illness including, but not limited to, ongoing or
active infection, hypertension, symptomatic congestive heart failure, unstable angina
pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would
limit compliance with study requirements

- Unable or unwilling to stop taking vitamins, herbal remedies, or nonprescription
medications

- Pregnant or breastfeeding

- Unable or unwilling to abide by the study protocol or cooperate fully with the
investigator or designee