An Open-label, Single Dose Study to Determine the Metabolism and Elimination of [14C]E2609 in Healthy Male Subjects
NCT01975636 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 113
Last updated 2016-01-08
Summary
This is an open-label, single dose study in healthy male subjects.
Conditions
- Metabolism and Elimination
Interventions
- DRUG
-
E2609
Single oral 100 mg +/- 10 mg E2609 with a level of radioactive exposure consistent with the Radioactive Drug Research Committee allowance
Sponsors & Collaborators
-
Eisai Inc.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2013-06-30
- Primary Completion
- 2013-11-30
- Completion
- 2014-03-31
Countries
- United States
Study Locations
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