Vitamin E δ-Tocotrienol (VEDT) Single Dose in Healthy Subjects

Vitamin E tocotrienols have been shown to exhibit cancer-preventive activities in
preclinical studies. Vitamin E tocotrienols are composed of α-, β-, δ-, and γ-tocotrienols.
The investigators preclinical studies indicate that δ-tocotrienol possesses the most potent
antitumor activity against pancreatic cancer. It is believed that this micronutrient may
have a role in the prevention of pancreatic cancer in healthy participants who are at
increased risk of developing the disease.

Inclusion Criteria:

- The participant is ≥ 18 years old

- The participant has an Eastern Cooperative Oncology Group (ECOG) performance status
of ≤ 2.

- The participant has adequate organ function as follows:

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

- Bilirubin ≤ the institutional upper limits of normal (ULN)

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

- Absolute neutrophil count (ANC) ≥ 1000mm³

- Platelet count ≥ 100,000/mm³

- The participant 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.

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

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

Exclusion Criteria:

- The participant is receiving investigational therapy (other than the investigational
therapy under study).

- The participant has 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.

- The participant has had prior major surgery within 30 days prior to first dose of
study drug.

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

- The participant has 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.

- The participant is unable or unwilling to stop taking vitamins, herbal remedies, or
nonprescription medications.

- The participant is pregnant or breastfeeding.

- The participant is unable or unwilling to abide by the study protocol or cooperate
fully with the investigator or designee.