Ongoing
Study Type: Phase 1, Interventional
Study Design: Open Label, Safety Efficacy Study
Subjects: Healthy volunteers
Intervention: Vitamin E δ-tocotrienol (Davos Life Science Pte Ltd)
Primary Outcome:
- Safety and tolerability of Vitamin E δ-Tocotrienol
- Maximum administered dose (MAD) or maximum tolerated dose (MTD) of Vitamin E δ-Tocotrienol
Secondary Outcome:
- Effects of dose on the plasma pharmacokinetic (PK) of Vitamin E δ-Tocotrienol
- Biomolecular markers not limited to Erk, p-Erk, AKT, p-AKT, p27, Ki-67, and exportin.
Methodology: Vitamin E δ-Tocotrienol will be administered orally as a single agent twice daily for 14 consecutive days. Vitamin E δ-Tocotrienol is supplied as 100-mg, 200-mg, and 400-mg capsules. The first cohort will be dosed with δ-tocotrienol at 100 mg twice daily for 14 consecutive days. A minimum of 3 subjects is planned for each dosing cohort with Vitamin E δ-Tocotrienol dose escalation dependent on safety and available PK data from prior cohorts. At the MTD or MAD, 20 subjects will be enrolled.