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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 is a Phase 1 study that has completed, run by Eisai. The registered enrollment target is 195 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02055703
The ClinicalTrials.gov registry entry for NCT02055703 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 195 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eisai, which has 287 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which itraconazole is the first listed.
NCT02055703 reports 0 study locations.
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.
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