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

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

This is a Phase 1, open-label, non-randomized, dose-finding, study of Vitamin E δ-Tocotrienol in subjects with resectable pancreatic tumors.

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.