Healthy Subjects
Conditions
Keywords
Healthy Subjects
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.
Interventions
Sponsors
Eisai Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed