Ignite Creation Date:
2024-05-05 @ 11:57 PM
Last Modification Date:
2024-10-26 @ 10:41 AM
Study NCT ID:
NCT01450046
Status:
COMPLETED
Last Update Posted:
2016-07-07
First Post:
2011-10-07
Brief Title:
Vitamin E δ-Tocotrienol Multiple Dose in Healthy Subjects
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
A Phase I Dose-Escalation Study of the Safety and Pharmacokinetics of Vitamin E δ-Tocotrienol Following Multiple Dose Administration in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The Principal Investigator believes that Vitamin E δ-Tocotrienol will slow the progression of pancreatic cancer cells Therefore the investigators must determine the safety and tolerability of Vitamin E δ-Tocotrienol in healthy participants before administering to cancer patients The investigators will do this by giving participants a dose of up to1600 mg twice a day not to exceed 3200 mg total for 14 consecutive days
Detailed Description:
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 procedures
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None