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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Healthy Subjects Renal Impairments

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Group A: Normal renal function

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

Group Type EXPERIMENTAL

Levetiracetam 500 mg

Intervention Type DRUG

Tablet containing Levetiracetam 500 mg

Group B: Mild renal impairment

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

Group Type EXPERIMENTAL

Levetiracetam 500 mg

Intervention Type DRUG

Tablet containing Levetiracetam 500 mg

Group C: Moderate renal impairment

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

Group Type EXPERIMENTAL

Levetiracetam 250 mg

Intervention Type DRUG

Tablet containing Levetiracetam 250 mg

Group D: Severe renal impairment

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 Type EXPERIMENTAL

Levetiracetam 250 mg

Intervention Type DRUG

Tablet containing Levetiracetam 250 mg

Group E: End-stage renal disease

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:

1. Dialysis: 44 h to 48 h after the first dose (Day 3)
2. Dialysis: 92 h to 96 h after the first dose (Day 5)
3. 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.

Group Type EXPERIMENTAL

Levetiracetam 250 mg

Intervention Type DRUG

Tablet containing Levetiracetam 250 mg

Levetiracetam 500 mg

Intervention Type DRUG

Tablet containing Levetiracetam 500 mg

Interventions

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Levetiracetam 250 mg

Tablet containing Levetiracetam 250 mg

Intervention Type DRUG

Levetiracetam 500 mg

Tablet containing Levetiracetam 500 mg

Intervention Type DRUG

Other Intervention Names

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E-Keppra E-Keppra

Eligibility Criteria

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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