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To investigate the Pharmacokinetics (PK) of oral administered Lacosamide in renal impaired subjects and healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Healthy subjects | Experimental | Single dose of 100 mg Lacosamide |
|
| Group 2: Subjects with mild renal insufficiency | Experimental | Single dose of 100 mg Lacosamide |
|
| Group 3: Subjects with moderate renal insufficiency | Experimental | Single dose of 100 mg Lacosamide |
|
| Group 4: Subjects with severe renal insufficiency | Experimental | Single dose of 100 mg Lacosamide |
|
| Group 5: Subjects with end stage renal insufficiency | Experimental | Single dose of 100 mg Lacosamide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lacosamide tablet | Drug | Single dose of 100 mg Lacosamide tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the Lacosamide plasma concentration time curve from 0 to the last quantifiable data point (AUC(0-tz)) | Blood sampling at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, and 96 hours after single dose administration; > 24 hours excluded for group 5 | Day 1 to Day 5 of study |
| Measured maximal concentration (Cmax) of Lacosamide | Blood sampling at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, and 96 hours after single dose administration; > 24 hours excluded for group 5 | Day 1 to Day 5 of study |
| Area under the Lacosamide plasma concentration-time curve from 0 to the last quantifiable data point (AUC (0-tz)), normalized by body weight | Blood sampling at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, and 96 hours after single dose administration; > 24 hours excluded for group 5 | Day 1 to Day 5 of study |
| Measured maximal concentration (Cmax, norm) of Lacosamide normalized by body weight | Blood sampling at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, and 96 hours after single dose administration; > 24 hours excluded for group 5 | Day 1 to Day 5 of study |
| Measure | Description | Time Frame |
|---|---|---|
| Time of observed maximum (tmax) of Lacosamide concentration | Blood sampling at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, and 96 hours after single dose administration; > 24 hours excluded for group 5 | Day 1 to Day 5 of study |
| Time of observed maximum (tmax) of Lacosamide metabolite (SPM12809) concentration |
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Inclusion Criteria:
Subjects with renal impairment also had to fulfill the following inclusion criteria:
Inclusion criteria for Group 5:
Exclusion Criteria:
Healthy subjects:
Exclusion criteria for Groups 2-4:
Exclusion criteria for Group 5:
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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 |
|---|---|---|---|---|---|---|
| 1 | Cologne | Germany | ||||
| 2 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23737404 | Derived | Cawello W, Fuhr U, Hering U, Maatouk H, Halabi A. Impact of impaired renal function on the pharmacokinetics of the antiepileptic drug lacosamide. Clin Pharmacokinet. 2013 Oct;52(10):897-906. doi: 10.1007/s40262-013-0080-7. |
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Blood sampling at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, and 96 hours after single dose administration; > 24 hours excluded for group 5 |
| Day 1 to Day 5 of study |
| Terminal half-life (t1/2) of Lacosamide | Blood sampling at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, and 96 hours after single dose administration; > 24 hours excluded for group 5 | Day 1 to Day 5 of study |
| Terminal half-life (t1/2) of Lacosamide metabolite (SPM12809) | Blood sampling at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, and 96 hours after single dose administration; > 24 hours excluded for group 5 | Day 1 to Day 5 of study |
| Apparent total clearance (CL/f) of Lacosamide from plasma | Blood sampling at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, and 96 hours after single dose administration; > 24 hours excluded for group 5 | Day 1 to Day 5 of study |
| Area under the lacosamide metabolite (SPM12809) plasma concentration-time curve from 0 to the last quantifiable data point (AUC(0-tz)) | Blood sampling at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, and 96 hours after single dose administration; > 24 hours excluded for group 5 | Day 1 to Day 5 of study |
| Amount of Lacosamide excreted in urine from 0 to defined time point (Ae(0-48)) (t=48 hours) | Urine sampling predose, 0-4, 4-8, 8-12, 12-24, 24-36, and 36-48 hours postdose | Day 1 to Day 3 of study |
| Amount of Lacosamide metabolite (SPM12809) excreted in urine from 0 to defined time point (Ae(0-48)) (t=48 hours) | Urine sampling predose, 0-4, 4-8, 8-12, 12-24, 24-36, and 36-48 hours postdose | Day 1 to Day 3 of study |
| Measured maximal concentration (Cmax) of Lacosamide metabolite (SPM12809) | Blood sampling at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, and 96 hours after single dose administration; > 24 hours excluded for group 5 | Day 1 to Day 5 of study |
| Area under the Lacosamide metabolite (SPM12809) plasma concentration time curve from 0 to the last quantifiable data point (AUC(0-tz)), normalized by body weight | Blood sampling at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, and 96 hours after single dose administration; > 24 hours excluded for group 5 | Day 1 to Day 5 of study |
| Measured maximal Lacosamide metabolite (SPM12809) concentration (Cmax,norm), normalized by body weight | Blood sampling at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, and 96 hours after single dose administration; > 24 hours excluded for group 5 | Day 1 to Day 5 of study |
| Terminal half-life (t1/2) of Lacosamide in urine | Urine sampling predose, 0-4, 4-8, 8-12, 12-24, 24-36, and 36-48 hours postdose | Day 1 to Day 3 of study |
| Lacosamide concentration in dialysis inlet line (Cin) | Dialysis samples collected 4 hours and 6 hours after administration (1.5 hours and 3.5 hours after start of dialysis) | From 4 hours up to 6 hours postdose |
| Lacosamide metabolite (SPM12809) concentration in dialysis inlet line (Cin) | Dialysis samples collected 4 hours and 6 hours after administration (1.5 hours and 3.5 hours after start of dialysis) | From 4 hours up to 6 hours postdose |
| Lacosamide concentration in dialysis outlet line (Cout) | Dialysis samples collected 4 hours and 6 hours after administration (1.5 hours and 3.5 hours after start of dialysis) | From 4 hours up to 6 hours postdose |
| Lacosamide metabolite (SPM12809) concentration in dialysis outlet line (Cout) | Dialysis samples collected 4 hours and 6 hours after administration (1.5 hours and 3.5 hours after start of dialysis) | From 4 hours up to 6 hours postdose |
| Extraction rate (E) of Lacosamide | Dialysis samples collected 4 hours and 6 hours after administration (1.5 hours and 3.5 hours after start of dialysis) | From 4 hours up to 6 hours postdose |
| Extraction rate (E) of Lacosamide metabolite (SPM12809) | Dialysis samples collected 4 hours and 6 hours after administration (1.5 hours and 3.5 hours after start of dialysis) | From 4 hours up to 6 hours postdose |
| Dialysis clearance (CLdial) of Lacosamide | Dialysis samples collected 4 hours and 6 hours after administration (1.5 hours and 3.5 hours after start of dialysis) | From 4 hours up to 6 hours postdose |
| Dialysis clearance (CLdial) of Lacosamide metabolite (SPM12809) | Dialysis samples collected 4 hours and 6 hours after administration (1.5 hours and 3.5 hours after start of dialysis) | From 4 hours up to 6 hours postdose |
| Rate constant of Lacosamide elimination | Blood sampling at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, and 96 hours after single dose administration; > 24 hours excluded for group 5 | Day 1 to Day 5 of study |
| Rate constant of Lacosamide metabolite (SPM12809) elimination | Blood sampling at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, and 96 hours after single dose administration; > 24 hours excluded for group 5 | Day 1 to Day 5 of study |
| Rendsburg |
| Germany |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D000078334 | Lacosamide |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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