Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2025-12-26 @ 3:38 AM
Study NCT ID:
NCT01221818
Status:
COMPLETED
Last Update Posted:
2014-07-11
First Post:
2010-10-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Randomized, Double-Blind, Placebo-Controlled, Ascending Single Dose Study of E6007 in Healthy Subjects
Sponsor:
Eisai Inc.
Organization:
Study Overview
Official Title:
A Randomized, Double-Blind, Placebo-Controlled, Ascending Single Dose Study of E6007 in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2014-07
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 purpose of this study is to evaluate the safety and tolerability of single oral ascending doses of E6007 in healthy subjects.
Detailed Description:
This is a randomized, double-blind, placebo-controlled, ascending single dose study to evaluate the safety and tolerability of E6007 in healthy subjects. Six dose groups will be evaluated. Subjects will receive either 25 mg, 50 mg, 100 mg, 200 mg, 400 mg, or 600 mg E6007 or matching placebo tablets. Subjects will undergo screening evaluations, baseline evaluations, Day 1 (dosing day), and Days 2-5 evaluations. They will also have a follow-up visit on Day 90 and a Day 180 follow-up phone call.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: