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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E2609 | Experimental | Experimental drug for Parts A, B, and C |
|
| itraconazole | Active Comparator | Comparator drug for Part A1 |
|
| rifampin | Active Comparator | Comparator drug for Part A2 |
|
| digoxin | Active Comparator | Comparator drug for Part B |
|
| donepezil | Active Comparator | Comparator drug for Part C |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E2609 | Drug |
| ||
| itraconazole |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Up to 86 day (Part C) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 182 days |
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Inclusion Criteria
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| WCT Early Development | San Antonio | Texas | 78217 | United States |
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| Drug |
|
| rifampin | Drug |
|
| digoxin | Drug |
|
| donepezil | Drug |
|
| 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. |
| Up to 182 days |
| ID | Term |
|---|---|
| D017964 | Itraconazole |
| D012293 | Rifampin |
| D004077 | Digoxin |
| D000077265 | Donepezil |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010879 | Piperazines |
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D004071 | Digitalis Glycosides |
| D002298 | Cardenolides |
| D002301 | Cardiac Glycosides |
| D002297 | Cardanolides |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D007189 | Indans |
| D007192 | Indenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
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