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

Sponsor

Eisai Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT02055703

Collaborator

(none)

195

Enrollment

Location

Arms

3.9

Duration (Months)

49.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Subjects	Drug: E2609 Drug: itraconazole Drug: rifampin Drug: digoxin Drug: donepezil	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

195 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Study Start Date :

Jan 1, 2014

Actual Primary Completion Date :

Apr 1, 2014

Actual Study Completion Date :

May 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: E2609 Experimental drug for Parts A, B, and C	Drug: itraconazole Drug: rifampin Drug: digoxin Drug: donepezil
Active Comparator: itraconazole Comparator drug for Part A1	Drug: E2609
Active Comparator: rifampin Comparator drug for Part A2	Drug: E2609
Active Comparator: digoxin Comparator drug for Part B	Drug: E2609
Active Comparator: donepezil Comparator drug for Part C	Drug: E2609

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria

Healthy male or female subjects aged 18-55 years inclusive at the time of informed consent
Provide written informed consent
Willing and able to comply with all aspects of the protocol

Exclusion Criteria

Any history of seizures or epilepsy (not including a history of simple febrile seizures in childhood) or disturbance of consciousness likely to be due to seizures
A prolonged QT/QTc interval (QTc greater than 450 ms) as demonstrated by the mean of triplicate electrocardiograms (ECGs), recorded at least 1 min apart, at Screening or Baseline Periods
Evidence of clinically significant disease (eg, psychiatric disorders and disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, or cardiovascular system) that in the opinion of the investigator(s) could affect the subject's safety or interfere with the study assessments or subjects who have a congenital abnormality in metabolism within 4 weeks before dosing.
Any laboratory abnormalities considered clinically significant by the investigator, which may require further investigations or treatment
Clinically significant illness which required medical treatment within 8 weeks or a clinically significant infection within 4 weeks of dosing

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	WCT Early Development	San Antonio	Texas	United States	78217

Sponsors and Collaborators

Eisai Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Eisai Inc.

ClinicalTrials.gov Identifier:

NCT02055703

Other Study ID Numbers:

E2609-A001-003

First Posted:

Feb 5, 2014

Last Update Posted:

Nov 3, 2015

Last Verified:

Nov 1, 2015

Keywords provided by Eisai Inc.

Healthy Subjects

Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 3, 2015