NCT02055703

A 3-Part, Open-Label, Drug-Drug Interaction Study of Concomitant Administration of E2609 With Itraconazole, Rifampin, Digoxin, or Donepezil

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 195 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	E2609
DRUG	itraconazole
DRUG	rifampin
DRUG	digoxin
DRUG	donepezil

Timeline

• Start date: 2014-01-01
• Primary completion: 2014-04-01
• Completion: 2014-05-01
• First posted: 2014-02-05
• Last updated: 2015-11-03

Locations

1 site across 1 country: United States