A Randomized, Double-blind, Placebo-controlled, Sequential Ascending, Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2212 in Healthy Subjects
NCT ID: NCT01221259
Last Updated: 2013-05-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
60 participants
INTERVENTIONAL
2010-01-31
2012-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
TRIPLE
Study Groups
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Drug E2212
E2212
single ascending doses ranging from 10mg to 250mg
Placebo
placebo
a single dose of matching placebo
Interventions
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E2212
single ascending doses ranging from 10mg to 250mg
placebo
a single dose of matching placebo
Eligibility Criteria
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Inclusion Criteria
2. Body mass index (BMI) 18 and 30 kg/m2 at Screening;
3. Are willing and able to comply with all aspects of the protocol; and
4. Provide written informed consent.
Exclusion Criteria
2. History of serious medical illness
3. Smoking or use of tobacco-containing products within past 3 months
4. History of alcohol or drug abuse within past 2 years
18 Years
55 Years
ALL
Yes
Sponsors
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Eisai Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Philip Lee, Md
Role: PRINCIPAL_INVESTIGATOR
Quintiles Phase One Service
Locations
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Overland Park, Kansas, United States
Countries
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Other Identifiers
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E2212-A001-001
Identifier Type: -
Identifier Source: org_study_id
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