To investigate the Pharmacokinetics (PK) of oral administered Lacosamide in renal impaired subjects and healthy subjects.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Masking
NONE
Enrollment
40
Single dose of 100 mg Lacosamide tablet
1
Cologne, Germany
2
Rendsburg, Germany
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Day 1 to Day 5 of study
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
Time frame: Day 1 to Day 5 of study
Time of observed maximum (tmax) of Lacosamide metabolite (SPM12809) 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
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Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: Day 1 to Day 5 of study