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E5501 (5 mg, 20 mg, and 40 mg) will be administered to healthy male adults in a single-center, randomized, open-label, cross-over manner. This study will consist of 2 phases including pre-randomization (before drug administration) and postrandomization (after drug administration).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | E5501 5mg, then 20mg, then 40 mg, then 5mg |
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| Group B | Experimental | E5501 20mg, then 40mg, then 5 mg, then 5mg |
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| Group C | Experimental | E5501 40mg, then 5mg, then 20 mg, then 5mg |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group A: E5501 5mg, then 20mg, then 40 mg, then 5mg | Drug | The post-randomization phase consists of the Treatment Period 1 (Visits 2-8): participants received one 5 mg tablet under fed conditions on treatment morning for 28 days. Treatment Period II (visits 9-15): 20 mg (four 5 mg tablets) under fed conditions on treatment morning for 28 days. Treatment Period III (visits 16-22): 40 mg (eight 5 mg tablets) under fed conditions on treatment morning for 28 days. Treatment Period IV (visits 23-29): 5 mg tablet on treatment morning under fasted conditions for 28 days. The washout period of 27 days or longer was set between the administration of the study drug in Treatment Periods 1, 2 and 3 and that in Treatment Periods 2, 3 and 4 respectively. |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic Parameter: Maximal Drug Concentration (Cmax) Under Fed Conditions | 0, 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 36, 48, 72, 96 hours post-dose | |
| Pharmacokinetic Parameter: Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] Under Fed Conditions | AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t) | 0, 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 36, 48, 72, 96 hours post-dose |
| Pharmacokinetic Parameter: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - infinity)] Under Fed Conditions | AUC (0 - infinity)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - infinity). It is obtained from AUC (0 - t) plus AUC (t - infinity). | 0, 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 36, 48, 72, 96 hours post-dose |
| Pharmacokinetic Parameter: Time to Reach Maximum Observed Plasma Concentration (Tmax) Under Fed Conditions | 0, 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 36, 48, 72, 96 hours post-dose | |
| Pharmacokinetic Parameter: Plasma Decay Half-Life (t1/2) Under Fed Conditions | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | 0, 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 36, 48, 72, 96 hours post-dose |
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Inclusion criteria;
Exclusion criteria;
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| Name | Affiliation | Role |
|---|---|---|
| Fuminori Ohba | Eisai Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sumida City | Tokyo | Japan |
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| Group B: E5501 20mg, then 40mg, then 5 mg, then 5mg | Drug | The post-randomization phase consists of the Treatment Period 1 (Visits 2-8): participants received 20 mg (four 5 mg tablets) under fed conditions on treatment morning for 28 days. Treatment Period II (visits 9-15): 40 mg (eight 5 mg tablets) under fed conditions on treatment morning for 28 days. Treatment Period III (visits 16-22): one 5 mg tablet under fed conditions on treatment morning for 28 days. Treatment Period IV (visits 23-29): 5 mg tablet on treatment morning under fasted conditions for 28 days. The washout period of 27 days or longer was set between the administration of the study drug in Treatment Periods 1, 2 and 3 and that in Treatment Periods 2, 3 and 4 respectively. |
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| Group C: E5501 40mg, then 5mg, then 20 mg, then 5mg | Drug | The post-randomization phase consists of the Treatment Period 1 (Visits 2-8): participants received 40 mg (eight 5 mg tablets) under fed conditions on treatment morning for 28 days. Treatment Period II (visits 9-15): one 5 mg tablet under fed conditions on treatment morning for 28 days. Treatment Period III (visits 16-22): 20 mg (four 5 mg tablets) under fed conditions on treatment morning for 28 days. Treatment Period IV (visits 23-29): 5 mg tablet on treatment morning under fasted conditions for 28 days. The washout period of 27 days or longer was set between the administration of the study drug in Treatment Periods 1, 2 and 3 and that in Treatment Periods 2, 3 and 4 respectively. |
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