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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-023164-40 | EudraCT Number |
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The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of lacosamide following single oral administration of lacosamide 100 mg, 200 mg and 400 mg in healthy male Chinese and Japanese subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lacosamide 100 mg, Japanese | Experimental | 1 Lacosamide 100 mg tablet plus 3 placebo tablets |
|
| Lacosamide 100 mg, Chinese | Experimental | 1 Lacosamide 100 mg tablet plus 3 placebo tablets |
|
| Lacosamide 200 mg, Japanese | Experimental | 2 Lacosamide 100 mg tablets plus 2 placebo tablets |
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| Lacosamide 200 mg, Chinese | Experimental | 2 Lacosamide 100 mg tablets plus 2 placebo tablets |
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| Lacosamide 400 mg, Japanese | Experimental | 4 Lacosamide 100 mg tablets |
|
| Lacosamide 400 mg, Chinese | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lacosamide | Drug | 100 mg oral tablet, single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum drug concentration (Cmax) of lacosamide in plasma. | Multiple sampling from 0 to 72 hours following single dose in each treatment period | |
| Area under the curve from 0 to the time of the last quantifiable concentration (AUC(0-t)) of lacosamide in plasma | Multiple sampling from 0 to 72 hours following single dose in each treatment period | |
| Area under the curve from 0 to infinity (AUC) of lacosamide in plasma | Multiple sampling from 0 to 72 hours following single dose in each treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Time to reach maximum plasma concentration (tmax) of lacosamide in plasma | Multiple sampling from 0 to 72 hours following single dose in each treatment period | |
| Terminal half-life (t½) of lacosamide in plasma | Multiple sampling from 0 to 72 hours following single dose in each treatment period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neuss | Germany |
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| ID | Term |
|---|---|
| D000078334 | Lacosamide |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 |
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4 Lacosamide 100 mg tablets
|
| Placebo Comparator, Japanese | Placebo Comparator | 4 placebo tablets |
|
| Placebo Comparator, Chinese | Placebo Comparator | 4 placebo tablets |
|
| Lacosamide | Drug | Lacosamide 2 X 100 mg tablet |
|
|
| Lacosamide | Drug | Lacosamide 4 X 100mg tablet |
|
|
| Placebo 3 | Other | Placebo - 3 tablets |
|
| Placebo 4 | Other | Placebo - 4 tablets |
|
| Placebo 2 | Other | Placebo - 2 tablets |
|
| Apparent total body clearance (CL/F) of lacosamide in plasma | Multiple sampling from 0 to 72 hours following single dose in each treatment period |
| Apparent volume of distribution (Vz/F) of lacosamide in plasma | Multiple sampling from 0 to 72 hours following single dose in each treatment period |
| Mean resident time (MRT) of lacosamide in plasma. | Multiple sampling from 0 to 72 hours following single dose in each treatment period |
| First order terminal elimination rate constant (λZ ) of lacosamide in plasma | Multiple sampling from 0 to 72 hours following single dose in each treatment period |
| Maximum drug concentration (Cmax) of SPM12809 in plasma. | Multiple sampling from 0 to 72 hours following single dose in each treatment period |
| Area under the curve from 0 to the time of the last quantifiable concentration (AUC(0-t)) of SPM12809 in plasma | Multiple sampling from 0 to 72 hours following single dose in each treatment period |
| Area under the curve from 0 to infinity (AUC) of SPM12809 in plasma | Multiple sampling from 0 to 72 hours following single dose in each treatment period |
| Time to reach maximum plasma concentration (tmax) of SPM12809 in plasma | Multiple sampling from 0 to 72 hours following single dose in each treatment period |
| Terminal half-life (t½) of SPM12809 in plasma | Multiple sampling from 0 to 72 hours following single dose in each treatment period |
| First order terminal elimination rate constant (λZ ) of SPM12809 in plasma | Multiple sampling from 0 to 72 hours following single dose in each treatment period |
| Total amount of drug excreted in urine (Ae) of lacosamide and SPM12809 | Multiple sampling from 0 to 72 hours following single dose in each treatment period |
| Fraction of dose excreted in urine (fe) of lacosamide and SPM12809 | Multiple sampling from 0 to 72 hours following single dose in each treatment period |
| Renal clearance (CLR) of lacosamide and SPM12809 | Multiple sampling from 0 to 72 hours following single dose in each treatment period |
| Apparent formation clearance of metabolites (CLfm/F) | Multiple sampling from 0 to 72 hours following single dose in each treatment period |
| AUC Ratio | Multiple sampling from 0 to 72 hours following single dose in each treatment period |
| Acids, Acyclic |
| D002264 | Carboxylic Acids |