Vitamin E δ-Tocotrienol (VEDT) Single Dose in Healthy Subjects
Raktažodžiai
Santrauka
apibūdinimas
Vitamin E tocotrienols have been shown to exhibit cancer-preventive activities in preclinical studies. Vitamin E tocotrienols are composed of α-, β-, δ-, and γ-tocotrienols. The investigators preclinical studies indicate that δ-tocotrienol possesses the most potent antitumor activity against pancreatic cancer. It is believed that this micronutrient may have a role in the prevention of pancreatic cancer in healthy participants who are at increased risk of developing the disease.
Datos
| Paskutinį kartą patikrinta: | 03/31/2016 |
| Pirmasis pateikimas: | 09/27/2011 |
| Numatytas registravimas pateiktas: | 10/03/2011 |
| Pirmas paskelbtas: | 10/04/2011 |
| Paskutinis atnaujinimas pateiktas: | 04/07/2016 |
| Paskutinis atnaujinimas paskelbtas: | 04/10/2016 |
| Faktinė studijų pradžios data: | 08/31/2011 |
| Numatoma pirminio užbaigimo data: | 08/31/2012 |
| Numatoma studijų užbaigimo data: | 03/31/2016 |
Būklė ar liga
Intervencija / gydymas
Drug: Dose Escalation
Fazė
Rankų grupės
| Ranka | Intervencija / gydymas |
|---|---|
| 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: Dose Escalation 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. |
Tinkamumo kriterijai
| Amžius, tinkami studijuoti | 18 Years Į 18 Years |
| Tinkamos studijoms lytys | All |
| Priima sveikus savanorius | Taip |
| Kriterijai | Inclusion Criteria: - The participant is ≥ 18 years old - The participant has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2. - The participant has adequate organ function as follows: - Serum creatinine ≤ 1.5 mg/dL or calculated creatinine clearance ≥ 60 mL/min. - Bilirubin ≤ the institutional upper limits of normal (ULN) - Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) to be within institutional normal range. - Absolute neutrophil count (ANC) ≥ 1000mm³ - Platelet count ≥ 100,000/mm³ - The participant has the capability of understanding the informed consent document and has signed the informed consent document. - Sexually active participants (male and female) must use medically acceptable methods of contraception during the course of the study. - Female participants of childbearing potential must have a negative pregnancy test at screening. - Able to understand and comply with the requirements of the protocol. Exclusion Criteria: - The participant is receiving investigational therapy (other than the investigational therapy under study). - The participant has received investigational therapy within 30 days prior to first dose of study drug. - Patients who are unable to swallow capsules. - Patients with prior malignancies, other than squamous or basal cell carcinomas, unless disease free for ≥ 5 years. - The participant has had prior major surgery within 30 days prior to first dose of study drug. - The participant has active infection or fever >38.5C within 3 days prior to first dose of study drug. - The participant has uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, hypertension, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. - The participant is unable or unwilling to stop taking vitamins, herbal remedies, or nonprescription medications. - The participant is pregnant or breastfeeding. - The participant is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee. |
Rezultatas
Pirminės rezultatų priemonės
1. Number of Participants With Adverse Events [3 weeks per participant]
Antrinės rezultatų priemonės
1. Number of Participants With Pharmacokinetic (PK) Markers of Vitamin E δ-Tocotrienol [3 weeks per participant]
2. Number of Participants With Pharmacodynamic (PD) Markers of Vitamin E δ-Tocotrienol [3 weeks per participant]
