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

Eisai

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: rifampin; Drug: E2609; Drug: donepezil; Drug: itraconazole; Drug: digoxin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02055703

E2609-A001-003

Details and patient eligibility

About

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.

Enrollment: 195 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

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

Exclusion Criteria

1. 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
2. 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
3. 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.
4. Any laboratory abnormalities considered clinically significant by the investigator, which may require further investigations or treatment
5. Clinically significant illness which required medical treatment within 8 weeks or a clinically significant infection within 4 weeks of dosing

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

195 participants in 5 patient groups

E2609

Experimental group

Description:

Experimental drug for Parts A, B, and C

Treatment:

Drug: donepezil

Drug: itraconazole

Drug: rifampin

Drug: digoxin

itraconazole

Active Comparator group

Description:

Comparator drug for Part A1

Treatment:

Drug: E2609

rifampin

Active Comparator group

Description:

Comparator drug for Part A2

Treatment:

Drug: E2609

digoxin

Active Comparator group

Description:

Comparator drug for Part B

Treatment:

Drug: E2609

donepezil

Active Comparator group

Description:

Comparator drug for Part C

Treatment:

Drug: E2609