A Randomized, Double-Blind, Placebo-Controlled, Ascending Single Dose Study of E6007 in Healthy Subjects
NCT01221818 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48
Last updated 2014-07-11
Summary
The purpose of this study is to evaluate the safety and tolerability of single oral ascending doses of E6007 in healthy subjects.
Conditions
Interventions
- DRUG
-
E6007
E6007 25mg single dose or matching placebo
- DRUG
-
E6007
E6007 50mg single dose or matching placebo
- DRUG
-
E6007
E6007 100mg single dose or matching placebo
- DRUG
-
E6007
E6007 200mg single dose or matching placebo
- DRUG
-
E6007
E6007 400mg single dose or matching placebo
- DRUG
-
E6007
E6007 600 mg single dose or matching placebo
Sponsors & Collaborators
-
Eisai Inc.
lead INDUSTRY
Principal Investigators
-
Gina Pastino · Eisai Inc.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2010-09-30
- Primary Completion
- 2011-10-31
Countries
- United States
Study Locations
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