This is a human pharmacology, single-dose study to investigate the pharmacokinetics of orally administered Levetiracetam (LEV) in Japanese subjects with normal renal function and in Japanese subjects with various degrees of impaired renal function.
The primary objective of this study is to evaluate the plasma and urine PK of Levetiracetam (ucb L059) and its metabolite (ucb L057) after a single dose of LEV 250 mg or LEV 500 mg in Japanese subjects with normal renal function and in Japanese subjects with various degrees of renal impairment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
30
Tablet containing Levetiracetam 250 mg
Tablet containing Levetiracetam 500 mg
1
Fukuoka, Japan
2
Ibaraki, Japan
Maximum Observed Plasma Concentration (Cmax) of Ucb L059 (LEV) for Groups A to D
Cmax refers to the maximum observed concentration of L059 (Levetiracetam). Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours
Time frame: From Baseline up to 144 hours post first dose
Area Under the Concentration-time Curve (AUC(0-t)) of Ucb L059 (LEV) From Baseline to the Last Quantifiable Concentration for Groups A to D
AUC(0-t) refers to the area under the plasma concentration versus time curve, which provides information on the exposure. Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours
Time frame: From Baseline up to 144 hours post first dose
Maximum Observed Plasma Concentration (Cmax) of Ucb L057 for Groups A to D
Cmax refers to the maximum observed concentration of ucb L057. Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours
Time frame: From Baseline up to 144 hours post first dose
Area Under the Concentration-time Curve (AUC(0-t)) of Ucb L057 From Baseline to the Last Quantifiable Concentration for Groups A to D
AUC(0-t) refers to the area under the plasma concentration versus time curve, which provides information on the exposure. Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours
Time frame: From Baseline up to 144 hours post first dose
Maximum Observed Plasma Concentration (Cmax) of Ucb L059 (LEV) for Group E During First Period
Cmax refers to the maximum observed concentration of ucb L059 (Levetiracetam).
Time frame: From Baseline to 44 hours post first dose
Area Under the Concentration-time Curve (AUC(0-t)) of Ucb L059 (LEV) From Baseline to 44 Hours for Group E
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AUC(0-t) refers to the area under the plasma concentration versus time curve, which provides information on the exposure.
Time frame: From Baseline to 44 hours post first dose
Maximum Observed Plasma Concentration (Cmax) of Ucb L057 for Group E During First Period
Cmax refers to the maximum observed concentration of ucb L057.
Time frame: From Baseline to 44 hours post first dose
Area Under the Concentration-time Curve (AUC(0-t)) of Ucb L057 From Baseline to 44 Hours for Group E
AUC(0-t) refers to the area under the plasma concentration versus time curve, which provides information on the exposure.
Time frame: From Baseline to 44 hours post first dose
Total Amount Excreted in Urine (Ae) of Ucb L059 (LEV) for Groups A to D
Ae refers to the total amount of ucb L059 (Levetiracetam) excreted in urine. Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours
Time frame: From Baseline up to 144 hours post first dose
Fraction of Dose Excreted in Urine (fe) of Ucb L059 (LEV) for Groups A to D
fe refers to the fraction of dose excreted in urine of L059 (Levetiracetam). Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours
Time frame: From Baseline up to 144 hours post first dose
Renal Clearance (CLR) of Ucb L059 (LEV) for Groups A to D
Renal clearance describes the removal of drug from a volume of plasma in a given unit of time by the kidneys. Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours
Time frame: From Baseline up to 144 hours post first dose
Apparent Total Body Clearance (CL/F) of Ucb L059 (LEV) for Groups A to D
Clearance (expressed as volume/time) describes the removal of drug from a volume of plasma in a given unit of time (drug loss from the body). It indicates the volume of plasma (or blood) from which the drug is completely removed, or cleared, in a given time period. Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours
Time frame: From Baseline up to 144 hours post first dose
Nonrenal Clearance (CLNR) of Ucb L059 (LEV) for Groups A to D
The Non-Renal Clearance (CLNR) describes the removal of drug by organs other than the kidneys. Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours
Time frame: From Baseline up to 144 hours post first dose
Total Amount Excreted in Urine (Ae) of Ucb L057 for Groups A to D
Ae refers to the total amount of ucb L057 excreted in urine. Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours
Time frame: From Baseline up to 144 hours post first dose
Renal Clearance (CLR) of Ucb L057 for Groups A to D
Renal clearance describes the removal of drug from a volume of plasma in a given unit of time by the kidneys. Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours
Time frame: From Baseline up to 144 hours post first dose
Apparent Total Body Clearance (CL/F) of Ucb L059 (LEV) for Group E During First Period
Clearance (expressed as volume/time) describes the removal of drug from a volume of plasma in a given unit of time (drug loss from the body). It indicates the volume of plasma (or blood) from which the drug is completely removed, or cleared, in a given time period. Geometric mean and Coefficient of Variation (CV) was not calculated since the extrapolated part of the AUC was greater than 20 %.
Time frame: From Baseline to 44 hours post first dose
Time to Reach Maximum Plasma Concentration (Tmax) of Ucb L059 (LEV) for Groups A to D
tmax refers to the time to reach maximum plasma concentration of ucb L059 (Levetiracetam). Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours
Time frame: From Baseline up to 144 hours post first dose
Area Under the Concentration-time Curve (AUC) of Ucb L059 (LEV) From Baseline to Infinite for Groups A to D
AUC(0-t) refers to the area under the plasma concentration versus time curve, which provides information on the exposure. Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours
Time frame: From Baseline up to 144 hours post first dose
Terminal Half-life (t1/2) of Ucb L059 (LEV) for Groups A to D
Terminal half-life refers to the time it takes for the concentrations to decrease by half. Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours
Time frame: From Baseline up to 144 hours post first dose
Time to Reach Maximum Plasma Concentration (Tmax) of Ucb L057 for Groups A to D
tmax refers to the time to reach maximum plasma concentration (tmax). Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours
Time frame: From Baseline up to 144 hours post first dose
Area Under the Concentration-time Curve (AUC) of Ucb L057 From Baseline to Infinite for Groups A to D
AUC(0-t) refers to the area under the plasma concentration versus time curve, which provides information on the exposure. Geometric mean and CV was not calculated since the extrapolated part of the AUC was greater than 20 %. Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours
Time frame: From Baseline up to 144 hours post first dose
Terminal Half-life (t1/2) of Ucb L057 for Groups A to D
Terminal half-life refers to the time it takes for the concentrations to decrease by half. Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours
Time frame: From Baseline up to 144 hours post first dose
Time to Reach Maximum Plasma Concentration (Tmax) of Ucb L059 (Levetiracetam) for Group E During First Period
tmax refers to the time to reach the maximum plasma concentration of ucb L059 (Levetiracetam).
Time frame: From Baseline to 44 hours post first dose
Area Under the Concentration-time Curve (AUC) of Ucb L059 (LEV) From Baseline to Infinite for Group E
AUC(0-t) refers to the area under the plasma concentration versus time curve, which provides information on the exposure. Geometric mean and CV was not calculated since the extrapolated part of the AUC was greater than 20 %.
Time frame: From Baseline to 140 hours post first dose
Terminal Half-life (t1/2) of Ucb L059 (LEV) for Group E During First Period
Terminal half-life refers to the time it takes for the concentrations to decrease by half. Geometric mean and CV was not calculated since the extrapolated part of the AUC was greater than 20 %.
Time frame: From Baseline to 44 hours post first dose
Time to Reach Maximum Plasma Concentration (Tmax) of Ucb L057 for Group E During First Period
tmax refers to the time to reach maximum plasma concentration (tmax).
Time frame: From Baseline to 44 hours post first dose
Hemodialysis Clearance (CLD) of Ucb L059 (LEV) During First Dialysis for Group E
Calculated by the Arterio - Venous difference method and cumulative dialysate method.
Time frame: From 44 hours to 48 hours post first dose
Ultrafiltration Clearance (CLUF) of Ucb L059 (LEV) During First Dialysis for Group E
Calculated by the Arterio - Venous difference method and cumulative dialysate method.
Time frame: From 44 hours to 48 hours post first dose
Hemodialysis Clearance (CLHD) of Ucb L059 (LEV) During First Dialysis for Group E
Calculated according: CLHD=CLD+CLUF.
Time frame: From 44 hours to 48 hours post first dose