Gamma-delta Tocotrienol as Potential Maintenance Treatment in Women With Metastatic Breast Cancer

Study Overview
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Brief Summary
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Twelve healthy volunteers who fit the inclusion and exclusion criteria and provide written informed consent to participate in the trial will be recruited to compare the rate and extent of absorption and pharmacokinetics of the newly formulated Gamma-Delta formulation with TRF.

Detailed Description
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Twelve healthy subjects will be admitted to a clinical study ward on the Day 0. Physical check up and the health status will be confirmed during check in. After fasting for a minimum of 10 hours overnight, each subject will be administered a single dose of TRF or Gamma-Delta after taking a standardized high-fat meal breakfast on Day 1. Thereafter, standard meals will be provided at 4 and 12 hours after dosing. Blood samples (5mL will be taken using an in-dwelling canula placed in the antecubital vein immediately before and at 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 14, and 24 hours after dosing. Subjects will be admitted for 24 hours and discharged after the last blood sampling. During the study, blood pressure and the heart rate will be monitored regularly for safety profile. After a one week wash out period, subject will return to the ward and be given the other formulation (TRF or GDT) and the same procedures will be repeated. Any adverse events that arise during the treatment will be recorded and followed up till resolution.

Official Title
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Phase 1a: A Randomized, 2-period Cross-over Study to Compare the Bioavailability of Gamma-Delta Tocotrienol (GDT) With That of Tocotrienol Rich Fraction (TRF) in Twelve Healthy Subjects

Conditions
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Healthy Subjects

Intervention / Treatment
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* Dietary Supplement: Gamma-Delta Tocotrienol and Tocotrienol Rich Fraction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female aged 21-55 years old Good health No allergy to vitamin E/ palm oil No past (within 3 months) / current use of dietary supplements containing vitamin E Exclusion Criteria: History of bleeding tendencies or any condition predisposing to bleeding e.g. thrombocytopenia, abnormal liver function, liver disease (e.g. chronic hepatitis), gastrointestinal ulcers Candidate for surgery or had undergone surgery in the past 6 months Current or past use (last 3 months) of antithrombotic drugs such as antiplatelets (aspirin, ticlopidine), anticoagulants (heparin, warfarin), thrombolytic agents (streptokinase), etc Current or past history of cancer Pregnant/ breastfeeding women Smokers Drug or alcohol abuse Hypercholesterolemia Chronic conditions such as uncontrolled hypertension, heart disease (ischemic heart disease, heart failure, cardiac arrhythmia), uncontrolled diabetes, HIV infection, or other psychiatric illness/ social situations that might limit adherence to study protocol. Unable or unwilling to stop taking vitamins, herbal preparations or nonprescription medications

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gamma-Delta Tocotrienol<br> | Dietary Supplement: Gamma-Delta Tocotrienol and Tocotrienol Rich Fraction<br>* Single oral TRF or Gamma-Delta Tocotrienol dosage<br>|
| Active Comparator: TRF<br> | Dietary Supplement: Gamma-Delta Tocotrienol and Tocotrienol Rich Fraction<br>* Single oral TRF or Gamma-Delta Tocotrienol dosage<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Plasma Concentration (Cmax)of drug |  | 0 to 24 hours after dosing |