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NCT02116907 · ClinicalTrials.gov registry record · Phase 1
An Open-Label, Single-Dose Study to Determine the Metabolism and Elimination of 14C-Perampanel in Healthy Male Subjects
A Phase 1 study of Healthy Subjects, sponsored by Eisai.
- Completed
- Registry status
- Phase 1
- Development phase
- 7
- Enrollment target
- 1
- Study location
NCT02116907: Completed Phase 1 study of Healthy Subjects, sponsored by Eisai.
NCT02116907 is a Phase 1 study of Healthy Subjects that has completed, run by Eisai. The registered enrollment target is 7 participants, below the 129-participant average among 69 other Healthy Subjects trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02116907, a Phase 1 study of Healthy Subjects, has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 7 participants
- Enrollment target
- 1
- Study location
Study Summary
This is an open-label, single-dose study in healthy male subjects. The study will have 2 phases: Pretreatment and Treatment. The Pretreatment Phase will last up to 21 days and will consist of a Screening Period and a Baseline Period, during which each subject's study eligibility will be determined and baseline assessments will be conducted.
Primary Outcome
These will be guided by analysis of 14C-perampanel, perampanel, and metabolites in the biological matrices.
Conditions Studied
Interventions
- DRUG E2007
Study Locations (1)
Wisconsin
- Covance Clinical Research Unit Inc. - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2014-05 |
| Est. Completion | 2014-09 |
| Phase | Phase 1 |
What the finished NCT02116907 record still lists
NCT02116907 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 129-participant average among 69 other Healthy Subjects trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Healthy Subjects appearing as the primary indexed condition, and to 1 intervention - of which E2007 is the first listed.
NCT02116907 reports a single indexed study location in Wisconsin.
Frequently Asked Questions
What is clinical trial NCT02116907 about?
NCT02116907 is a clinical study titled "An Open-Label, Single-Dose Study to Determine the Metabolism and Elimination of 14C-Perampanel in Healthy Male Subjects". This is an open-label, single-dose study in healthy male subjects. The study will have 2 phases: Pretreatment and Treatment. The Pretreatment Phase will last up to 21 days and will consist of a Screening Period and a Baseline Period, during which each subject's study eligibility will be determined a...
What is the current status of trial NCT02116907?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2014-05. Estimated completion is 2014-09.
What conditions does trial NCT02116907 study?
This clinical trial studies the following conditions: Healthy Subjects.
What interventions are being tested in trial NCT02116907?
The interventions under investigation include: E2007 (DRUG).
Who is sponsoring clinical trial NCT02116907?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02116907 being conducted?
This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy Subjects
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02116907's enrollment target sits among peer trials
7 67th of 69 higher than 3 of 69 other Healthy Subjects trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Subjects trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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