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

Jason Klapman, M.D.H. Lee Moffitt Cancer Center and Research Institute

Ongoing

Study Type: Interventional

Study Design: Non-randomized, Open Label, Dose-finding, Safety Efficacy Study

Subjects: Healthy volunteers

Intervention: Vitamin E delta-tocotrienol (Davos Life Science Pte Ltd)

Primary Outcome:

  • Safety and tolerability of Vitamin E δ-Tocotrienol
  • Minimally effective dose (MED) or maximum tolerated dose (MTD) of Vitamin E δ-tocotrienol administered once.

Secondary Outcome:

  • Pharmacokinetic (PK) markers of Vitamin E δ-Tocotrienol in the plasma, urine, and neoplastic tissue of participants with pancreatic neoplasia.
  • Pharmacodynamic (PD) Markers of Vitamin E δ-Tocotrienol in the plasma, urine, and neoplastic tissue of participants with pancreatic neoplasia.

Methodology: Not available

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