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

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Drug: E2609; Drug: itraconazole; Drug: rifampin; Drug: digoxin; Drug: donepezil

• Registration Number: NCT02055703
• Lead Sponsor: Eisai Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-23
• Study First Submitted QC: 2014-02-04
• Study First Posted: 2014-02-05
• Primary Completion: 2014-04
• Study Completion: 2014-05
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-02
• Last Update Posted: 2015-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 195

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
donepezil	E2609	Comparator drug for Part C
E2609	itraconazole	Experimental drug for Parts A, B, and C
itraconazole	E2609	Comparator drug for Part A1
E2609	donepezil	Experimental drug for Parts A, B, and C
rifampin	E2609	Comparator drug for Part A2
digoxin	E2609	Comparator drug for Part B
E2609	rifampin	Experimental drug for Parts A, B, and C
E2609	digoxin	Experimental drug for Parts A, B, and C

Primary Outcome Measures

Name	Time	Method
To evaluate the pharmacokinetics (PK) of single oral doses of E2609 and metabolites in subjects dosed alone or in combination with either rifampin or itraconazole	Up to 48 days (Part A)	Primary PK Parameters being measured: AUC(0-t), AUC(0-inf), Cmax, tmax.
To evaluate the PK of single oral doses of digoxin in subjects dosed alone or in combination with E2609	Up to 48 days (Part B)	Primary PK Parameters being measured: AUC(0-t), AUC(0-inf), Cmax, tmax.
To evaluate the PK of single oral doses of E2609 and metabolites in subjects dosed alone, in combination with donepezil, or 2 hours before donepezil dosing	Up to 86 day (Part C)	Primary PK Parameters being measured: AUC(0-t), AUC(0-inf), Cmax, tmax.

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability of single oral doses of E2609 in subjects in the presence and absence of rifampin, itraconazole, digoxin, or donepezil	Up to 182 days	Safety assessments include monitoring and recording all adverse events (AEs), regular measurement of vital signs, and the performance of physical examinations.
To evaluate the effects of DNA sequence variants potentially involved in absorption, distribution and metabolism of E2609.	Up to 182 days	DNA samples will be collected, stored, and may be used to examine the role of genetic variability in other genes potentially involved in absorption, distribution, metabolism, and excretion.

Trial Locations

Locations (1)

WCT Early Development; 🇺🇸 San Antonio, Texas, United States