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To assess the PK and safety after administration of three types of E0302 SR tablets (SR1, SR2, SR3) and E0302 IR tablet.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: E0302 Sustained Release (SR1) 1500 mcg | Experimental | Participants will receive a single dose of E0302 SR1 1500 microgram (mcg), tablet, orally on Day 1. |
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| Cohort 2: E0302 Sustained Release (SR3) 1500 mcg | Experimental | Participants will receive a single dose of E0302 SR3 1500 mcg, tablet on Day 1. |
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| Cohort 3: E0302 SR2 1500 mcg + E0302 IR 500 mcg | Experimental | Participants will receive a single dose of E0302 SR2 1500 mcg tablet (Treatment A) on Day 1 in Treatment Period 1 followed by single dose of E0302 IR 500 mcg tablet (Treatment B) on Day 7 in Treatment Period 2. A wash-out phase of at least 5 days will be maintained between the treatment periods. |
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| Cohort 3: E0302 IR 500 mcg + E0302 SR2 500 mcg | Experimental | Participants will receive a single dose of E0302 IR 500 mcg tablet (Treatment B) on Day 1 in Treatment Period 1 followed by single dose of E0302 SR2 1500 mcg tablet (Treatment A) on Day 7 in Treatment Period 2. A wash-out phase of at least 5 days will be maintained between the treatment periods. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E0302 SR1 | Drug | E0302 SR1, oral tablet. |
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| Measure | Description | Time Frame |
|---|---|---|
| Cmax: Maximum Observed Plasma Concentration for E0302 SR1, SR2, SR3 and IR | Cohort 1 and 2 Day 1: 0-72 hours post dose; Cohort 3 Day 1 or 7: 0-72 hours post dose | |
| AUC (0-t): Area Under the Concentration-Time Curve From Zero Time to Time of Last Quantifiable Concentration | Cohort 1 and 2 Day 1: 0-72 hours post dose, Cohort 3 Day 1 or 7: 0-72 hours post dose | |
| AUC (0 - infinity): Area Under the Concentration-Time Curve From Zero Time Extrapolated to Infinite Time | Cohort 1 and 2 Day 1: 0-72 hours post dose, Cohort 3 Day 1 or 7: 0-72 hours post dose | |
| Number of Participants With Serious Adverse Events (SAEs) and Non-Serious Adverse Events (Non-SAEs) | Cohort 1 and Cohort 2: Up to 12 days, Cohort 3: Up to 18 days | |
| Number of Participants With Abnormal Clinical Laboratory Values | Cohort 1 and Cohort 2: Up to Day 4, Cohort 3: Up to Day 10 | |
| Number of Participants With Abnormal Vital Sign Values | Cohort 1 and Cohort 2: Up to Day 2, Cohort 3: Up to Day 8 | |
| Number of Participants With Abnormal 12-lead Electrocardiogram Values | Cohort 1 and Cohort 2: Up to Day 12, Cohort 3: Up to Day 18 |
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Inclusion Criteria:
Participants must meet all of the following criteria to be included in this study:
1. Body mass index (BMI) of 18 to 30 kilogram per meter square [kg/m2], inclusive at Screening
Exclusion Criteria:
Participants who meet any of the following criteria will be excluded from this study:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Auckland Clinical Studies | Auckland | New Zealand |
Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
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Cohort 1 and Cohort 2 will receive treatment as parallel assignment. Cohort 3 will receive treatment in cross-over manner.
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| E0302 SR3 |
| Drug |
E0302 SR3, oral tablet. |
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| E0302 SR2 | Drug | E0302 SR2, oral tablet. |
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| E0302 IR | Drug | E0302 IR, oral tablet. |
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