Clinical trial NCT01491113
Conditions: Healthy Subjects Renal Impairments
Keywords: Levetiracetam Oral administration Japanese Non-epileptic Healthy Renal impaired subjects
Sponsor: UCB Pharma
Start date: 2011-11-01; Completion date: 2012-11-01
Enrollment: 30 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

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.

Arms: arm 1: 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 2: 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 3: 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 4: 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 5: 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.
Interventions: intervention 1: Levetiracetam 250 mg intervention 2: Levetiracetam 500 mg
Intervention descriptions: intervention 1: Tablet containing Levetiracetam 250 mg intervention 2: Tablet containing Levetiracetam 500 mg

Protocol documents: