A Phase I Dose-Escalation Study of the Safety and Pharmacokinetics of Vitamin E δ-Tocotrienol Following Multiple Dose Administration in Healthy Subjects
Participants will be accrued in cohorts of three. The decision to dose escalate will be made
by the Cohort Review Committee (CRC) based on safety after the last subject in the current
cohort has completed the Study Treatment Period. The study will consist of the following
- Pre-Treatment Period: The screening period must occur within 7 days of dosing.
- Study Treatment Period (14 days): Vitamin E δ-Tocotrienol will be administered orally
twice daily for 14 consecutive days
- Post-Treatment Period: Subject will return to the study site 7 days after the dose of
Vitamin E δ-Tocotrienol for an end-of-treatment assessment. On day 8 (± 2 days) after
the last dose of study drug, the investigator will obtain follow-up information. Any
serious adverse events (SAEs) present at 7 days after the last dose and possibly
related to study drug will be followed until resolution, stabilization, or initiation
of treatment that confounds the ability to assess the event.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Number of Participants With Treatment Related Adverse Events
The primary objective of this study is to evaluate the safety and tolerability of Vitamin E δ-Tocotrienol and to determine the maximum administered dose (MAD) or maximum tolerated dose (MTD) of Vitamin E δ-Tocotrienol administered twice daily for 14 days. Safety analyses and summary tables will include data collected for all subjects who receive at least one dose of study drug.
3 Weeks Per Participant
Shivakumar Vignesh, M.D.
H. Lee Moffitt Cancer Center and Research Institute
United States: Food and Drug Administration
|H. Lee Moffitt Cancer Center and Research Institute||Tampa, Florida 33612|