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NCT02085967 · ClinicalTrials.gov registry record · Phase 1
A 2-Part Study to Assess Potential Metabolism-Based Drug-Drug Interactions of E2006 When Coadministered With Itraconazole, Rifampin, Midazolam, or Bupropion
A Phase 1 study, sponsored by Eisai.
- Completed
- Registry status
- Phase 1
- Development phase
- 106
- Enrollment target
NCT02085967 is a Phase 1 study that has completed, run by Eisai. The registered enrollment target is 106 participants.
The verdict
NCT02085967, a Phase 1 study, has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 106 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 2 parts. In Part A, the effects of steady-state dosing of a strong CYP3A inhibitor (itraconazole) or inducer (rifampin) on the pharmacokinetics of E2006 and metabolites will be assessed. Approximately 30 subjects will be sequentially assigned to 1 of 2 treatment groups to receive itraconazole or rifampin in equal numbers (approximately 15 subjects per group). The itraconazole treatment group will be fully enrolled before enrollment is initiated for the rifampin treatment group. In Part B, the effects of steady-state dosing of E2006 on the pharmacokinetics of midazolam, a substrate of CYP3A, plus bupropion, a substrate of CYP2B6, will be assessed in approximately 24 subjects. The 2 study parts can be conducted in parallel.
Interventions
- DRUG E2006
- DRUG rifampin 600 mg
- DRUG itraconazole 200 mg
- DRUG midazolam 2 mg with bupropion 75 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 106 participants |
| Start Date | 2014-02 |
| Est. Completion | 2014-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02085967
The ClinicalTrials.gov registry entry for NCT02085967 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 106 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 4 interventions - of which E2006 is the first listed.
NCT02085967 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02085967 about?
NCT02085967 is a clinical study titled "A 2-Part Study to Assess Potential Metabolism-Based Drug-Drug Interactions of E2006 When Coadministered With Itraconazole, Rifampin, Midazolam, or Bupropion". This study will be a single center, open-label, drug-drug interaction study in healthy male and female subjects. The study will consist of 2 parts. In Part A, the effects of steady-state dosing of a strong CYP3A inhibitor (itraconazole) or inducer (rifampin) on the pharmacokinetics of E2006 and meta...
What is the current status of trial NCT02085967?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 106 participants. The study started on 2014-02. Estimated completion is 2014-06.
What interventions are being tested in trial NCT02085967?
The interventions under investigation include: E2006 (DRUG), rifampin 600 mg (DRUG), itraconazole 200 mg (DRUG), midazolam 2 mg with bupropion 75 mg (DRUG).
Who is sponsoring clinical trial NCT02085967?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
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