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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
195
WCT Early Development
San Antonio, Texas, United States
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
Primary PK Parameters being measured: AUC(0-t), AUC(0-inf), Cmax, tmax.
Time frame: Up to 48 days (Part A)
To evaluate the PK of single oral doses of digoxin in subjects dosed alone or in combination with E2609
Primary PK Parameters being measured: AUC(0-t), AUC(0-inf), Cmax, tmax.
Time frame: Up to 48 days (Part B)
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
Primary PK Parameters being measured: AUC(0-t), AUC(0-inf), Cmax, tmax.
Time frame: Up to 86 day (Part C)
Safety and tolerability of single oral doses of E2609 in subjects in the presence and absence of rifampin, itraconazole, digoxin, or donepezil
Safety assessments include monitoring and recording all adverse events (AEs), regular measurement of vital signs, and the performance of physical examinations.
Time frame: Up to 182 days
To evaluate the effects of DNA sequence variants potentially involved in absorption, distribution and metabolism of E2609.
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.
Time frame: Up to 182 days
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