A 3-Part, Open-Label, Drug-Drug Interaction Study of Concomitant Administration of E2609 With Itraconazole, Rifampin, Digoxin, or Donepezil
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 4/21/2016 |
| Start Date: | January 2014 |
| End Date: | May 2014 |
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.
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.
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
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