Vitamin E δ-Tocotrienol (VEDT) Single Dose in Healthy Subjects
|ClinicalTrials.gov Identifier: NCT01446952|
Recruitment Status : Completed
First Posted : October 5, 2011
Last Update Posted : April 11, 2016
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: Vitamin E δ-Tocotrienol||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Dose-Escalation Study of the Safety and Pharmacokinetics of Vitamin E δ-Tocotrienol Following Single Dose Administration in Healthy Subjects|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||April 2016|
Experimental: Dose Escalation
Vitamin E δ-Tocotrienol will be administered orally as a single agent once. Vitamin E δ-Tocotrienol is supplied as 100-mg, 200-mg, and 400-mg capsules.
Drug: Vitamin E δ-Tocotrienol
The first cohort will be dosed with δ-tocotrienol at 200 mg. A minimum of 3 participants is planned for each dosing cohort with Vitamin E δ-Tocotrienol dose escalation dependent on safety from prior cohorts.
Other Name: Delta-tocotrienol
- Number of Participants With Adverse Events [ Time Frame: 3 weeks per participant ]The primary objective of this study is to evaluate the safety and tolerability of Vitamin E δ-Tocotrienol and to determine the minimally effective dose (MED) or maximum tolerated dose (MTD) of Vitamin E δ-Tocotrienol administered once. Safety will be assessed by standard clinical findings and laboratory tests. Toxicity grade is defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE)v.4.0. Ninety-five percent confidence intervals may be calculated for selected safety and exploratory variables.
- Number of Participants With Pharmacokinetic (PK) Markers of Vitamin E δ-Tocotrienol [ Time Frame: 3 weeks per participant ]Pharmacokinetic (PK) markers of Vitamin E δ-Tocotrienol in the plasma, urine, and neoplastic tissue of participants with pancreatic neoplasia. To determine the effects of dose on the plasma pharmacokinetic (PK) of Vitamin E δ-Tocotrienol when orally administered as a single dose in healthy subjects. Ninety-five percent confidence intervals may be calculated for selected safety and exploratory variables. Dose escalation will be based on safety and available PK data.
- Number of Participants With Pharmacodynamic (PD) Markers of Vitamin E δ-Tocotrienol [ Time Frame: 3 weeks per participant ]Pharmacodynamic (PD) Markers of Vitamin E δ-Tocotrienol in the plasma, urine, and neoplastic tissue of participants with pancreatic neoplasia. To evaluate pharmacodynamic (PD) markers of Vitamin E δ-Tocotrienol activity in peripheral blood. Ninety-five percent confidence intervals may be calculated for selected safety and exploratory variables. Correlative analysis of PD data will be done.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01446952
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Jason Klapman, M.D.||H. Lee Moffitt Cancer Center and Research Institute|