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Pharmacokinetic (PK) Study in Japanese Non-epileptic Renal Impaired Patients

Primary Purpose

Healthy Subjects, Renal Impairments

Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Levetiracetam 250 mg
Levetiracetam 500 mg
Sponsored by
UCB Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Healthy Subjects focused on measuring Levetiracetam, Oral administration, Japanese, Non-epileptic, Healthy, Renal impaired subjects

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy subjects with normal renal function
  • Subject is Japanese
  • Subjects with creatinine clearance within 1 of 3 Groups (CLcr[mL/min/1.73 cm^2]: Group B: 50 - <80, Group C: 30 - <50, Group D: <30), or for Group E, subjects with end-stage renal failure undergoing hemodialysis

Exclusion Criteria:

  • Subjects has taken any drug treatment, disease or injury to influence Levetiracetam PK except for renal impairments

Sites / Locations

  • 1
  • 2

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Group A: Normal renal function

Group B: Mild renal impairment

Group C: Moderate renal impairment

Group D: Severe renal impairment

Group E: End-stage renal disease

Arm Description

Subjects who have normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects will be orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings will be taken through to Day 4 during the Treatment Period, and safety follow-up assessments will be performed on Day 8 according to the schedule of study assessments. Blood samples for Pharmacokinetics (PK): Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose Urine samples for PK: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose

Patients who have mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects will be orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings will be conducted through Day 5 during the Treatment Period, and safety follow-up assessments will be performed on Day 8 according to the schedule of study assessments. Blood samples for Pharmacokinetics (PK): Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose Urine samples for PK: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose

Patients who have moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects will be orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings will be conducted through Day 6 during the Treatment Period, and safety follow-up assessments will be performed on Day 8 according to the schedule of study assessments. Blood samples for Pharmacokinetics (PK): Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose Urine samples for PK: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose

Patients who have severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects will be orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings will be conducted through Day 7 during the Treatment Period, and safety follow-up assessments will be performed on Day 8 according to the schedule of study assessments. Blood samples for Pharmacokinetics (PK): Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose Urine samples for PK: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose

Group E will receive Levetiracetam (LEV) 500 mg on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg will be administered 1 h after the end of the first hemodialysis on Day 3. The 4-h Hemodialysis are scheduled as follows: Dialysis: 44 h to 48 h after the first dose (Day 3) Dialysis: 92 h to 96 h after the first dose (Day 5) Dialysis: 140 h after the first dose (Day 7) Safety assessments and blood samplings will be conducted until Day 7. Safety follow-up assessments will be performed on Day 10. Blood samples for Pharmacokinetics (PK): Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 30, 44*, 44.25*, 44.5*, 45*, 46*, 47*, 48*, 49, 49.5, 50, 51, 53, 55, 57, 61, 73, 92, 96, 120, 140 hours post first dosing. 49 h-sample should be taken before the additional dose. The 44 h, 92 h, and 140 h sample should be taken before the start of the hemodialysis. *Inflow blood, outflow blood, and dialysate fluid will be collected.

Outcomes

Primary Outcome Measures

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
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
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
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
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).
Area Under the Concentration-time Curve (AUC(0-t)) of Ucb L059 (LEV) 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.
Maximum Observed Plasma Concentration (Cmax) of Ucb L057 for Group E During First Period
Cmax refers to the maximum observed concentration of ucb L057.
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.

Secondary Outcome Measures

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
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
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
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
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
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
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
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 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
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
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 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
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
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 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).
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 %.
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 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).
Hemodialysis Clearance (CLD) of Ucb L059 (LEV) During First Dialysis for Group E
Calculated by the Arterio - Venous difference method and cumulative dialysate method.
Ultrafiltration Clearance (CLUF) of Ucb L059 (LEV) During First Dialysis for Group E
Calculated by the Arterio - Venous difference method and cumulative dialysate method.
Hemodialysis Clearance (CLHD) of Ucb L059 (LEV) During First Dialysis for Group E
Calculated according: CLHD=CLD+CLUF.

Full Information

First Posted
December 9, 2011
Last Updated
January 13, 2014
Sponsor
UCB Pharma
Collaborators
Parexel
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1. Study Identification

Unique Protocol Identification Number
NCT01491113
Brief Title
Pharmacokinetic (PK) Study in Japanese Non-epileptic Renal Impaired Patients
Official Title
Single-Dose Pharmacokinetics of Orally Administered Levetiracetam (LEV) in Japanese Subjects With Normal Renal Function and Various Degrees of Renal Impairment Using a Dosing Regimen Adjusted to Renal Function (250 mg or 500 mg)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Pharma
Collaborators
Parexel

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Subjects, Renal Impairments
Keywords
Levetiracetam, Oral administration, Japanese, Non-epileptic, Healthy, Renal impaired subjects

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A: Normal renal function
Arm Type
Experimental
Arm Description
Subjects who have normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects will be orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings will be taken through to Day 4 during the Treatment Period, and safety follow-up assessments will be performed on Day 8 according to the schedule of study assessments. Blood samples for Pharmacokinetics (PK): Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose Urine samples for PK: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose
Arm Title
Group B: Mild renal impairment
Arm Type
Experimental
Arm Description
Patients who have mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects will be orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings will be conducted through Day 5 during the Treatment Period, and safety follow-up assessments will be performed on Day 8 according to the schedule of study assessments. Blood samples for Pharmacokinetics (PK): Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose Urine samples for PK: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose
Arm Title
Group C: Moderate renal impairment
Arm Type
Experimental
Arm Description
Patients who have moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects will be orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings will be conducted through Day 6 during the Treatment Period, and safety follow-up assessments will be performed on Day 8 according to the schedule of study assessments. Blood samples for Pharmacokinetics (PK): Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose Urine samples for PK: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose
Arm Title
Group D: Severe renal impairment
Arm Type
Experimental
Arm Description
Patients who have severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects will be orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings will be conducted through Day 7 during the Treatment Period, and safety follow-up assessments will be performed on Day 8 according to the schedule of study assessments. Blood samples for Pharmacokinetics (PK): Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose Urine samples for PK: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose
Arm Title
Group E: End-stage renal disease
Arm Type
Experimental
Arm Description
Group E will receive Levetiracetam (LEV) 500 mg on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg will be administered 1 h after the end of the first hemodialysis on Day 3. The 4-h Hemodialysis are scheduled as follows: Dialysis: 44 h to 48 h after the first dose (Day 3) Dialysis: 92 h to 96 h after the first dose (Day 5) Dialysis: 140 h after the first dose (Day 7) Safety assessments and blood samplings will be conducted until Day 7. Safety follow-up assessments will be performed on Day 10. Blood samples for Pharmacokinetics (PK): Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 30, 44*, 44.25*, 44.5*, 45*, 46*, 47*, 48*, 49, 49.5, 50, 51, 53, 55, 57, 61, 73, 92, 96, 120, 140 hours post first dosing. 49 h-sample should be taken before the additional dose. The 44 h, 92 h, and 140 h sample should be taken before the start of the hemodialysis. *Inflow blood, outflow blood, and dialysate fluid will be collected.
Intervention Type
Drug
Intervention Name(s)
Levetiracetam 250 mg
Other Intervention Name(s)
E-Keppra
Intervention Description
Tablet containing Levetiracetam 250 mg
Intervention Type
Drug
Intervention Name(s)
Levetiracetam 500 mg
Other Intervention Name(s)
E-Keppra
Intervention Description
Tablet containing Levetiracetam 500 mg
Primary Outcome Measure Information:
Title
Maximum Observed Plasma Concentration (Cmax) of Ucb L059 (LEV) for Groups A to D
Description
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
Title
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
Description
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
Title
Maximum Observed Plasma Concentration (Cmax) of Ucb L057 for Groups A to D
Description
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
Title
Area Under the Concentration-time Curve (AUC(0-t)) of Ucb L057 From Baseline to the Last Quantifiable Concentration for Groups A to D
Description
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
Title
Maximum Observed Plasma Concentration (Cmax) of Ucb L059 (LEV) for Group E During First Period
Description
Cmax refers to the maximum observed concentration of ucb L059 (Levetiracetam).
Time Frame
From Baseline to 44 hours post first dose
Title
Area Under the Concentration-time Curve (AUC(0-t)) of Ucb L059 (LEV) From Baseline to 44 Hours for Group E
Description
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
Title
Maximum Observed Plasma Concentration (Cmax) of Ucb L057 for Group E During First Period
Description
Cmax refers to the maximum observed concentration of ucb L057.
Time Frame
From Baseline to 44 hours post first dose
Title
Area Under the Concentration-time Curve (AUC(0-t)) of Ucb L057 From Baseline to 44 Hours for Group E
Description
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
Secondary Outcome Measure Information:
Title
Total Amount Excreted in Urine (Ae) of Ucb L059 (LEV) for Groups A to D
Description
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
Title
Fraction of Dose Excreted in Urine (fe) of Ucb L059 (LEV) for Groups A to D
Description
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
Title
Renal Clearance (CLR) of Ucb L059 (LEV) for Groups A to D
Description
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
Title
Apparent Total Body Clearance (CL/F) of Ucb L059 (LEV) for Groups A to D
Description
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
Title
Nonrenal Clearance (CLNR) of Ucb L059 (LEV) for Groups A to D
Description
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
Title
Total Amount Excreted in Urine (Ae) of Ucb L057 for Groups A to D
Description
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
Title
Renal Clearance (CLR) of Ucb L057 for Groups A to D
Description
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
Title
Apparent Total Body Clearance (CL/F) of Ucb L059 (LEV) for Group E During First Period
Description
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
Title
Time to Reach Maximum Plasma Concentration (Tmax) of Ucb L059 (LEV) for Groups A to D
Description
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
Title
Area Under the Concentration-time Curve (AUC) of Ucb L059 (LEV) From Baseline to Infinite for Groups A to D
Description
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
Title
Terminal Half-life (t1/2) of Ucb L059 (LEV) for Groups A to D
Description
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
Title
Time to Reach Maximum Plasma Concentration (Tmax) of Ucb L057 for Groups A to D
Description
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
Title
Area Under the Concentration-time Curve (AUC) of Ucb L057 From Baseline to Infinite for Groups A to D
Description
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
Title
Terminal Half-life (t1/2) of Ucb L057 for Groups A to D
Description
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
Title
Time to Reach Maximum Plasma Concentration (Tmax) of Ucb L059 (Levetiracetam) for Group E During First Period
Description
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
Title
Area Under the Concentration-time Curve (AUC) of Ucb L059 (LEV) From Baseline to Infinite for Group E
Description
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
Title
Terminal Half-life (t1/2) of Ucb L059 (LEV) for Group E During First Period
Description
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
Title
Time to Reach Maximum Plasma Concentration (Tmax) of Ucb L057 for Group E During First Period
Description
tmax refers to the time to reach maximum plasma concentration (tmax).
Time Frame
From Baseline to 44 hours post first dose
Title
Hemodialysis Clearance (CLD) of Ucb L059 (LEV) During First Dialysis for Group E
Description
Calculated by the Arterio - Venous difference method and cumulative dialysate method.
Time Frame
From 44 hours to 48 hours post first dose
Title
Ultrafiltration Clearance (CLUF) of Ucb L059 (LEV) During First Dialysis for Group E
Description
Calculated by the Arterio - Venous difference method and cumulative dialysate method.
Time Frame
From 44 hours to 48 hours post first dose
Title
Hemodialysis Clearance (CLHD) of Ucb L059 (LEV) During First Dialysis for Group E
Description
Calculated according: CLHD=CLD+CLUF.
Time Frame
From 44 hours to 48 hours post first dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy subjects with normal renal function Subject is Japanese Subjects with creatinine clearance within 1 of 3 Groups (CLcr[mL/min/1.73 cm^2]: Group B: 50 - <80, Group C: 30 - <50, Group D: <30), or for Group E, subjects with end-stage renal failure undergoing hemodialysis Exclusion Criteria: Subjects has taken any drug treatment, disease or injury to influence Levetiracetam PK except for renal impairments
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
+1 877 822 9493 (UCB)
Official's Role
Study Director
Facility Information:
Facility Name
1
City
Fukuoka
Country
Japan
Facility Name
2
City
Ibaraki
Country
Japan

12. IPD Sharing Statement

Links:
URL
http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

Pharmacokinetic (PK) Study in Japanese Non-epileptic Renal Impaired Patients

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