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NCT02859207 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Pharmacokinetics of E2609 and Its Metabolites in Subjects With Mild and Moderate Hepatic Impairment Compared With Healthy Subjects
A Phase 1 study, sponsored by Eisai.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT02859207: Completed Phase 1 study, sponsored by Eisai.
NCT02859207 is a Phase 1 study that has completed, run by Eisai. The registered enrollment target is 32 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02859207, a Phase 1 study, has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study Summary
The primary objective of the study is to evaluate the effects of hepatic impairment on the pharmacokinetics (PK) of E2609 after a single dose administration.
Primary Outcome
Blood samples for pharmacokinetic (PK) assessments will be collected on Day 1 (before dosing and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after dosing), Day 2 (24 and 36 hours after dosing), Day 3 (48 hours after dosing), Day 4 (72 hours after dosing), Day 5 (96 hours after dosing), Day 6 (120 hours after dosing), and Day 7 (144 hours after dosing).
Interventions
- DRUG E2609
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2016-08 |
| Est. Completion | 2017-01-25 |
| Phase | Phase 1 |
What the finished NCT02859207 record still lists
NCT02859207 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 1 intervention - of which E2609 is the first listed.
NCT02859207 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02859207 about?
NCT02859207 is a clinical study titled "A Study to Evaluate the Pharmacokinetics of E2609 and Its Metabolites in Subjects With Mild and Moderate Hepatic Impairment Compared With Healthy Subjects". The primary objective of the study is to evaluate the effects of hepatic impairment on the pharmacokinetics (PK) of E2609 after a single dose administration.
What is the current status of trial NCT02859207?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2016-08. Estimated completion is 2017-01-25.
What interventions are being tested in trial NCT02859207?
The interventions under investigation include: E2609 (DRUG).
Who is sponsoring clinical trial NCT02859207?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02859207's enrollment target sits among peer trials
32 1296th of 2000 higher than 679 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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