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NCT02055703 · ClinicalTrials.gov registry record · Phase 1
A 3-Part, Open-Label, Drug-Drug Interaction Study of Concomitant Administration of E2609 With Itraconazole, Rifampin, Digoxin, or Donepezil
A Phase 1 study, sponsored by Eisai.
- Completed
- Registry status
- Phase 1
- Development phase
- 195
- Enrollment target
NCT02055703: Completed Phase 1 study, sponsored by Eisai.
NCT02055703 is a Phase 1 study that has completed, run by Eisai. The registered enrollment target is 195 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (225% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02055703, a Phase 1 study, has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 195 participants
- Enrollment target
Study Summary
This study will be a single-center, open-label, drug-drug interaction study in healthy male and female subjects. The study will consist of 3 parts: A, B, and C. In Part A, the effect of itraconazole or rifampin on the pharmacokinetics (PK) of E2609 and metabolites will be assessed. Approximately 32 subjects will be assigned to 1 of 2 treatment groups (itraconazole or rifampin) in equal numbers, with approximately 16 subjects per group. In Part B, the effects of steady-state dosing of E2609 on the PK of digoxin will be assessed in approximately 18 subjects. In Part C, the effects of donepezil administered in combination with, or 2 hours after, E2609 dosing on the PK of E2609 and metabolites, will be assessed in approximately 24 subjects.
Primary Outcome
Primary PK Parameters being measured: AUC(0-t), AUC(0-inf), Cmax, tmax.
Interventions
- DRUG itraconazole
- DRUG E2609
- DRUG digoxin
- DRUG rifampin
- DRUG donepezil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 195 participants |
| Start Date | 2014-01 |
| Est. Completion | 2014-05 |
| Phase | Phase 1 |
What the finished NCT02055703 record still lists
NCT02055703 is an interventional study that assigns participants to a tested intervention. The registered 195 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (225% higher).
The record links to 0 conditions, and to 5 interventions - of which itraconazole is the first listed.
NCT02055703 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02055703 about?
NCT02055703 is a clinical study titled "A 3-Part, Open-Label, Drug-Drug Interaction Study of Concomitant Administration of E2609 With Itraconazole, Rifampin, Digoxin, or Donepezil". This study will be a single-center, open-label, drug-drug interaction study in healthy male and female subjects. The study will consist of 3 parts: A, B, and C. In Part A, the effect of itraconazole or rifampin on the pharmacokinetics (PK) of E2609 and metabolites will be assessed. Approximately 32 ...
What is the current status of trial NCT02055703?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 195 participants. The study started on 2014-01. Estimated completion is 2014-05.
What interventions are being tested in trial NCT02055703?
The interventions under investigation include: itraconazole (DRUG), E2609 (DRUG), digoxin (DRUG), rifampin (DRUG), donepezil (DRUG).
Who is sponsoring clinical trial NCT02055703?
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 NCT02055703's enrollment target sits among peer trials
195 281st of 2000 higher than 1,719 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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