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

Completed · Phase 1

Conditions studied: Healthy Subjects

In brief

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.

Key facts

Study ID

NCT02055703

Run by

Eisai Inc.

People needed

195

Starts

2014-01-01

Expected to finish

2014-05-01

Last updated by the study team

2015-11-03

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• WCT Early Development — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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