Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT01491113
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01491113
Recruitment Status : Completed
First Posted : December 13, 2011
Results First Posted : January 10, 2014
Last Update Posted : February 10, 2014
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
UCB Pharma

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Conditions Healthy Subjects
Renal Impairments
Interventions Drug: Levetiracetam 250 mg
Drug: Levetiracetam 500 mg
Enrollment 30
Recruitment Details The Participant Flow refers to the Safety Set population which includes all patients that received at least one dose of study medication.
Pre-assignment Details About 30 (28 to 30) subjects were planned to be enrolled for 5 groups (A to E) according to their renal function based on the value of creatinine clearance (CLCr).
Arm/Group Title 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
Hide Arm/Group Description

Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose

Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose

Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose

Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose

Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.

The 4-h Hemodialysis was 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 were conducted until Day 7. Safety follow-up assessments were 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 was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.

*Inflow blood, outflow blood, and dialysate fluid were collected.
Period Title: Overall Study
Started 6 6 6 6 6
Completed 6 6 6 6 6
Not Completed 0 0 0 0 0
Arm/Group Title 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 Total
Hide Arm/Group Description

Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose

Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetics (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose

Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose

Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose

Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.

The 4-h Hemodialysis was 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 were conducted until Day 7. Safety follow-up assessments were performed on Day 10.

Blood samples for Pharmacokinetic (PK) analyses: 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 was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.

*Inflow blood, outflow blood, and dialysate fluid were collected.

 Total of all reporting groups
Overall Number of Baseline Participants 6 6 6 6 6 30
Hide Baseline Analysis Population Description
The Baseline Analysis Population refers to the Pharmacokinetic Per Protocol Set (PK-PPS) which consists of all subjects included in the Safety Set (SS), who also had a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the PK parameters.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 6 participants 6 participants 6 participants 30 participants
61.7  (2.6) 67.5  (5.0) 69.3  (6.1) 55.8  (17.1) 68.8  (7.9) 64.6  (10.0)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 6 participants 6 participants 6 participants 6 participants 6 participants 30 participants
20 - <65 years 5 3 1 4 2 15
>=65 years 1 3 5 2 4 15
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 6 participants 6 participants 6 participants 30 participants
Female
1
  16.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   3.3%
Male
5
  83.3%
6
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
29
  96.7%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Asian Number Analyzed 6 participants 6 participants 6 participants 6 participants 6 participants 30 participants
6 6 6 6 6 30
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Japanese Number Analyzed 6 participants 6 participants 6 participants 6 participants 6 participants 30 participants
6 6 6 6 6 30
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilogram
Number Analyzed 6 participants 6 participants 6 participants 6 participants 6 participants 30 participants
60.95  (10.97) 74.28  (4.14) 63.07  (12.49) 58.70  (6.10) 62.20  (5.41) 63.84  (9.62)
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeters
Number Analyzed 6 participants 6 participants 6 participants 6 participants 6 participants 30 participants
161.73  (9.05) 165.65  (3.11) 163.72  (5.64) 164.50  (6.34) 162.38  (3.41) 163.60  (5.68)
1.Primary Outcome
Title Maximum Observed Plasma Concentration (Cmax) of Ucb L059 (LEV) for Groups A to D
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.
Arm/Group Title Group A: Normal Renal Function Group B: Mild Renal Impairment Group C: Moderate Renal Impairment Group D: Severe Renal Impairment
Hide Arm/Group Description:

Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose

Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose

Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose

Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose
Overall Number of Participants Analyzed 6 6 6 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: µg/mL
21.9357
(31.2%)
15.5334
(25.3%)
10.7767
(24.3%)
9.1754
(30.4%)
2.Primary Outcome
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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.
Arm/Group Title Group A: Normal Renal Function Group B: Mild Renal Impairment Group C: Moderate Renal Impairment Group D: Severe Renal Impairment
Hide Arm/Group Description:

Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose

Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose

Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose

Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose
Overall Number of Participants Analyzed 6 6 6 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h*µg/mL
165.9996
(16.5%)
247.6430
(16.9%)
169.3392
(16.5%)
212.1193
(19.1%)
3.Primary Outcome
Title Maximum Observed Plasma Concentration (Cmax) of Ucb L057 for Groups A to D
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.
Arm/Group Title Group A: Normal Renal Function Group B: Mild Renal Impairment Group C: Moderate Renal Impairment Group D: Severe Renal Impairment
Hide Arm/Group Description:

Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose

Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose

Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose

Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose
Overall Number of Participants Analyzed 6 6 6 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: µg/mL
0.3620
(9.4%)
0.7503
(25.8%)
0.5674
(26.0%)
1.0640
(29.3%)
4.Primary Outcome
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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.
Arm/Group Title Group A: Normal Renal Function Group B: Mild Renal Impairment Group C: Moderate Renal Impairment Group D: Severe Renal Impairment
Hide Arm/Group Description:

Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose

Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose

Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose

Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose
Overall Number of Participants Analyzed 6 6 6 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h*µg/mL
5.8607
(9.7%)
22.5573
(45.9%)
18.6675
(53.4%)
57.7773
(57.3%)
5.Primary Outcome
Title Maximum Observed Plasma Concentration (Cmax) of Ucb L059 (LEV) for Group E During First Period
Hide Description Cmax refers to the maximum observed concentration of ucb L059 (Levetiracetam).
Time Frame From Baseline to 44 hours post first dose
Hide Outcome Measure Data
Hide Analysis Population Description
The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.
Arm/Group Title Group E: End-stage Renal Disease
Hide Arm/Group Description:

Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.

The 4-h Hemodialysis was 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 were conducted until Day 7. Safety follow-up assessments were performed on Day 10.

Blood samples for Pharmacokinetic (PK) analyses: 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 was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.

*Inflow blood, outflow blood, and dialysate fluid were collected.
Overall Number of Participants Analyzed 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: µg/mL
18.6810
(8.1%)
6.Primary Outcome
Title Area Under the Concentration-time Curve (AUC(0-t)) of Ucb L059 (LEV) From Baseline to 44 Hours for Group E
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.
Arm/Group Title Group E: End-stage Renal Disease
Hide Arm/Group Description:

Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.

The 4-h Hemodialysis was 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 were conducted until Day 7. Safety follow-up assessments were performed on Day 10.

Blood samples for Pharmacokinetic (PK) analyses: 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 was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.

*Inflow blood, outflow blood, and dialysate fluid were collected.
Overall Number of Participants Analyzed 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h*µg/mL
462.4883
(10.5%)
7.Primary Outcome
Title Maximum Observed Plasma Concentration (Cmax) of Ucb L057 for Group E During First Period
Hide Description Cmax refers to the maximum observed concentration of ucb L057.
Time Frame From Baseline to 44 hours post first dose
Hide Outcome Measure Data
Hide Analysis Population Description
The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.
Arm/Group Title Group E: End-stage Renal Disease
Hide Arm/Group Description:

Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.

The 4-h Hemodialysis was 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 were conducted until Day 7. Safety follow-up assessments were performed on Day 10.

Blood samples for Pharmacokinetics (PK) analyses: 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 was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.

*Inflow blood, outflow blood, and dialysate fluid were collected.
Overall Number of Participants Analyzed 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: µg/mL
8.8435
(7.0%)
8.Primary Outcome
Title Area Under the Concentration-time Curve (AUC(0-t)) of Ucb L057 From Baseline to 44 Hours for Group E
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.
Arm/Group Title Group E: End-stage Renal Disease
Hide Arm/Group Description:

Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.

The 4-h Hemodialysis was 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 were conducted until Day 7. Safety follow-up assessments were performed on Day 10.

Blood samples for Pharmacokinetic (PK) analyses: 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 was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.

*Inflow blood, outflow blood, and dialysate fluid were collected.
Overall Number of Participants Analyzed 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h*µg/mL
230.4393
(7.8%)
9.Secondary Outcome
Title Total Amount Excreted in Urine (Ae) of Ucb L059 (LEV) for Groups A to D
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.
Arm/Group Title Group A: Normal Renal Function Group B: Mild Renal Impairment Group C: Moderate Renal Impairment Group D: Severe Renal Impairment
Hide Arm/Group Description:

Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose

Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose

Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose

Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose
Overall Number of Participants Analyzed 4 6 6 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mg
304.7321
(30.3%)
247.6562
(12.5%)
98.7182
(11.9%)
74.3761
(34.4%)
10.Secondary Outcome
Title Fraction of Dose Excreted in Urine (fe) of Ucb L059 (LEV) for Groups A to D
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.
Arm/Group Title Group A: Normal Renal Function Group B: Mild Renal Impairment Group C: Moderate Renal Impairment Group D: Severe Renal Impairment
Hide Arm/Group Description:

Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose

Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose

Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose

Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose
Overall Number of Participants Analyzed 4 6 6 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Percentage of Dose Administered
60.9464
(30.3%)
49.5312
(12.5%)
39.4873
(11.9%)
29.7504
(34.4%)
11.Secondary Outcome
Title Renal Clearance (CLR) of Ucb L059 (LEV) for Groups A to D
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.
Arm/Group Title Group A: Normal Renal Function Group B: Mild Renal Impairment Group C: Moderate Renal Impairment Group D: Severe Renal Impairment
Hide Arm/Group Description:

Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose

Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose

Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose

Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose
Overall Number of Participants Analyzed 4 6 6 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: L/h
1.8622
(27.4%)
0.9820
(22.1%)
0.5671
(17.6%)
0.3417
(49.3%)
12.Secondary Outcome
Title Apparent Total Body Clearance (CL/F) of Ucb L059 (LEV) for Groups A to D
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.
Arm/Group Title Group A: Normal Renal Function Group B: Mild Renal Impairment Group C: Moderate Renal Impairment Group D: Severe Renal Impairment
Hide Arm/Group Description:

Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose

Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose

Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose

Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose
Overall Number of Participants Analyzed 6 6 6 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: L/h
2.9359
(14.8%)
1.9826
(16.0%)
1.4362
(15.3%)
1.1484
(19.1%)
13.Secondary Outcome
Title Nonrenal Clearance (CLNR) of Ucb L059 (LEV) for Groups A to D
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.
Arm/Group Title Group A: Normal Renal Function Group B: Mild Renal Impairment Group C: Moderate Renal Impairment Group D: Severe Renal Impairment
Hide Arm/Group Description:

Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose

Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose

Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose

Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose
Overall Number of Participants Analyzed 4 6 6 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: L/h
1.0712
(50.6%)
0.9873
(17.4%)
0.8636
(18.4%)
0.7848
(17.9%)
14.Secondary Outcome
Title Total Amount Excreted in Urine (Ae) of Ucb L057 for Groups A to D
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.
Arm/Group Title Group A: Normal Renal Function Group B: Mild Renal Impairment Group C: Moderate Renal Impairment Group D: Severe Renal Impairment
Hide Arm/Group Description:

Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose

Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose

Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose

Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose
Overall Number of Participants Analyzed 4 6 6 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mg
83.5936
(16.9%)
169.3395
(19.0%)
93.1346
(14.0%)
100.7489
(17.8%)
15.Secondary Outcome
Title Renal Clearance (CLR) of Ucb L057 for Groups A to D
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.
Arm/Group Title Group A: Normal Renal Function Group B: Mild Renal Impairment Group C: Moderate Renal Impairment Group D: Severe Renal Impairment
Hide Arm/Group Description:

Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose

Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose

Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose

Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose
Overall Number of Participants Analyzed 4 6 6 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: L/h
14.6937
(18.3%)
6.8015
(32.6%)
4.6828
(45.6%)
1.6475
(42.0%)
16.Secondary Outcome
Title Apparent Total Body Clearance (CL/F) of Ucb L059 (LEV) for Group E During First Period
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.
Arm/Group Title Group E: End-stage Renal Disease
Hide Arm/Group Description:

Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.

The 4-h Hemodialysis was 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 were conducted until Day 7. Safety follow-up assessments were performed on Day 10.

Blood samples for Pharmacokinetic (PK) analyses: 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 was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.

*Inflow blood, outflow blood, and dialysate fluid were collected.
Overall Number of Participants Analyzed 6
Median (Full Range)
Unit of Measure: L/h
0.629
(0.500 to 0.801)
17.Secondary Outcome
Title Time to Reach Maximum Plasma Concentration (Tmax) of Ucb L059 (LEV) for Groups A to D
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.
Arm/Group Title Group A: Normal Renal Function Group B: Mild Renal Impairment Group C: Moderate Renal Impairment Group D: Severe Renal Impairment
Hide Arm/Group Description:

Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose

Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose

Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose

Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose
Overall Number of Participants Analyzed 6 6 6 6
Median (Full Range)
Unit of Measure: hours
0.500
(0.500 to 2.000)
1.000
(0.500 to 2.000)
0.500
(0.500 to 1.000)
0.500
(0.500 to 1.000)
18.Secondary Outcome
Title Area Under the Concentration-time Curve (AUC) of Ucb L059 (LEV) From Baseline to Infinite for Groups A to D
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.
Arm/Group Title Group A: Normal Renal Function Group B: Mild Renal Impairment Group C: Moderate Renal Impairment Group D: Severe Renal Impairment
Hide Arm/Group Description:

Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose

Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose

Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose

Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose
Overall Number of Participants Analyzed 6 6 6 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h*µg/mL
170.3045
(14.8%)
252.1923
(16.0%)
174.0764
(15.3%)
217.6854
(19.1%)
19.Secondary Outcome
Title Terminal Half-life (t1/2) of Ucb L059 (LEV) for Groups A to D
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.
Arm/Group Title Group A: Normal Renal Function Group B: Mild Renal Impairment Group C: Moderate Renal Impairment Group D: Severe Renal Impairment
Hide Arm/Group Description:

Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose

Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose

Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose

Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose
Overall Number of Participants Analyzed 6 6 6 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hours
7.6164
(6.9%)
12.6214
(11.3%)
15.5033
(17.5%)
19.7320
(26.5%)
20.Secondary Outcome
Title Time to Reach Maximum Plasma Concentration (Tmax) of Ucb L057 for Groups A to D
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.
Arm/Group Title Group A: Normal Renal Function Group B: Mild Renal Impairment Group C: Moderate Renal Impairment Group D: Severe Renal Impairment
Hide Arm/Group Description:

Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose

Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose

Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose

Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose
Overall Number of Participants Analyzed 6 6 6 6
Median (Full Range)
Unit of Measure: hours
5.000
(2.000 to 8.000)
8.000
(6.000 to 12.000)
12.000
(8.000 to 12.000)
24.000
(12.000 to 24.000)
21.Secondary Outcome
Title Area Under the Concentration-time Curve (AUC) of Ucb L057 From Baseline to Infinite for Groups A to D
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.
Arm/Group Title Group A: Normal Renal Function Group B: Mild Renal Impairment Group C: Moderate Renal Impairment Group D: Severe Renal Impairment
Hide Arm/Group Description:

Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose

Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose

Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose

Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose
Overall Number of Participants Analyzed 5 4 4 4
Median (Full Range)
Unit of Measure: h*µg/mL
8.176
(7.432 to 11.085)
32.401
(28.910 to 38.917)
27.441
(16.472 to 41.184)
63.126
(48.016 to 171.348)
22.Secondary Outcome
Title Terminal Half-life (t1/2) of Ucb L057 for Groups A to D
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.
Arm/Group Title Group A: Normal Renal Function Group B: Mild Renal Impairment Group C: Moderate Renal Impairment Group D: Severe Renal Impairment
Hide Arm/Group Description:

Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose

Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose

Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose

Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose
Overall Number of Participants Analyzed 5 4 4 4
Median (Full Range)
Unit of Measure: hours
12.351
(11.348 to 15.310)
19.030
(17.331 to 19.903)
20.303
(19.681 to 23.569)
26.769
(17.249 to 33.348)
23.Secondary Outcome
Title Time to Reach Maximum Plasma Concentration (Tmax) of Ucb L059 (Levetiracetam) for Group E During First Period
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.
Arm/Group Title Group E: End-stage Renal Disease
Hide Arm/Group Description:

Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.

The 4-h Hemodialysis was 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 were conducted until Day 7. Safety follow-up assessments were performed on Day 10.

Blood samples for Pharmacokinetic (PK) analyses: 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 was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.

*Inflow blood, outflow blood, and dialysate fluid were collected.
Overall Number of Participants Analyzed 6
Median (Full Range)
Unit of Measure: hours
0.720
(0.430 to 0.980)
24.Secondary Outcome
Title Area Under the Concentration-time Curve (AUC) of Ucb L059 (LEV) From Baseline to Infinite for Group E
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.
Arm/Group Title Group E: End-stage Renal Disease
Hide Arm/Group Description:

Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.

The 4-h Hemodialysis was 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 were conducted until Day 7. Safety follow-up assessments were performed on Day 10.

Blood samples for Pharmacokinetic (PK) analyses: 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 was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.

*Inflow blood, outflow blood, and dialysate fluid were collected.
Overall Number of Participants Analyzed 6
Median (Full Range)
Unit of Measure: h*µg/mL
794.588
(624.521 to 999.853)
25.Secondary Outcome
Title Terminal Half-life (t1/2) of Ucb L059 (LEV) for Group E During First Period
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.
Arm/Group Title Group E: End-stage Renal Disease
Hide Arm/Group Description:

Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.

The 4-h Hemodialysis was 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 were conducted until Day 7. Safety follow-up assessments were performed on Day 10.

Blood samples for Pharmacokinetic (PK) analyses: 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 was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.

*Inflow blood, outflow blood, and dialysate fluid were collected.
Overall Number of Participants Analyzed 6
Median (Full Range)
Unit of Measure: hours
34.669
(29.227 to 38.648)
26.Secondary Outcome
Title Time to Reach Maximum Plasma Concentration (Tmax) of Ucb L057 for Group E During First Period
Hide Description tmax refers to the time to reach maximum plasma concentration (tmax).
Time Frame From Baseline to 44 hours post first dose
Hide Outcome Measure Data
Hide Analysis Population Description
The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.
Arm/Group Title Group E: End-stage Renal Disease
Hide Arm/Group Description:

Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.

The 4-h Hemodialysis was 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 were conducted until Day 7. Safety follow-up assessments were performed on Day 10.

Blood samples for Pharmacokinetic (PK) analyses: 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 was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.

*Inflow blood, outflow blood, and dialysate fluid were collected.
Overall Number of Participants Analyzed 6
Median (Full Range)
Unit of Measure: hours
44.020
(44.000 to 44.030)
27.Secondary Outcome
Title Hemodialysis Clearance (CLD) of Ucb L059 (LEV) During First Dialysis for Group E
Hide Description Calculated by the Arterio - Venous difference method and cumulative dialysate method.
Time Frame From 44 hours to 48 hours post first dose
Hide Outcome Measure Data
Hide Analysis Population Description
The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.
Arm/Group Title Group E: End-stage Renal Disease
Hide Arm/Group Description:

Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.

The 4-h Hemodialysis was 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 were conducted until Day 7. Safety follow-up assessments were performed on Day 10.

Blood samples for Pharmacokinetic (PK) analyses: 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 was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.

*Inflow blood, outflow blood, and dialysate fluid were collected.
Overall Number of Participants Analyzed 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mL/min
113.9665
(8.5%)
28.Secondary Outcome
Title Ultrafiltration Clearance (CLUF) of Ucb L059 (LEV) During First Dialysis for Group E
Hide Description Calculated by the Arterio - Venous difference method and cumulative dialysate method.
Time Frame From 44 hours to 48 hours post first dose
Hide Outcome Measure Data
Hide Analysis Population Description
The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.
Arm/Group Title Group E: End-stage Renal Disease
Hide Arm/Group Description:

Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.

The 4-h Hemodialysis was 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 were conducted until Day 7. Safety follow-up assessments were performed on Day 10.

Blood samples for Pharmacokinetic (PK) analyses: 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 was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.

*Inflow blood, outflow blood, and dialysate fluid were collected.
Overall Number of Participants Analyzed 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mL/min
1.3271
(32.5%)
29.Secondary Outcome
Title Hemodialysis Clearance (CLHD) of Ucb L059 (LEV) During First Dialysis for Group E
Hide Description Calculated according: CLHD=CLD+CLUF.
Time Frame From 44 hours to 48 hours post first dose
Hide Outcome Measure Data
Hide Analysis Population Description
The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.
Arm/Group Title Group E: End-stage Renal Disease
Hide Arm/Group Description:

Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.

The 4-h Hemodialysis was 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 were conducted until Day 7. Safety follow-up assessments were performed on Day 10.

Blood samples for Pharmacokinetics (PK) analysis: 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 was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.

*Inflow blood, outflow blood, and dialysate fluid were collected.
Overall Number of Participants Analyzed 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mL/min
115.3702
(8.1%)
Time Frame Treatment-Emergent Adverse Events were reported from Day 1 up to Day 8 (+2 days) for Group A to D and from Day 1 up to Day 10 (+2 days) for Group E.
Adverse Event Reporting Description Treatment-Emergent Adverse Events (TEAEs) were reported. TEAEs are defined as those adverse events that either start or worsen in intensity on or after the date/time of first dose of study treatment.
 
Arm/Group Title 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
Hide Arm/Group Description

Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose

Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetics (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose

Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose

Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

  • Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose
  • Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose

Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.

The 4-h Hemodialysis was 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 were conducted until Day 7. Safety follow-up assessments were performed on Day 10.

Blood samples for Pharmacokinetic (PK) analyses: 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 was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.

*Inflow blood, outflow blood, and dialysate fluid were collected.
All-Cause Mortality
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
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
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
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      1/6 (16.67%)    
Infections and infestations           
Pneumonia * 1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Injury, poisoning and procedural complications           
Shunt malfunction * 1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Respiratory, thoracic and mediastinal disorders           
Acute respiratory distress syndrome * 1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
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
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/6 (0.00%)      2/6 (33.33%)      0/6 (0.00%)      1/6 (16.67%)      2/6 (33.33%)    
Gastrointestinal disorders           
Gingivitis * 1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Toothache * 1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
General disorders           
Pyrexia * 1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Infections and infestations           
Nasopharyngitis * 1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Injury, poisoning and procedural complications           
Postoperative wound complication * 1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Investigations           
White blood cell count increased * 1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Musculoskeletal and connective tissue disorders           
Muscle spasms * 1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Nervous system disorders           
Dizziness * 1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Respiratory, thoracic and mediastinal disorders           
Cough * 1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Productive cough * 1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Vascular disorders           
Hypotension * 1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.1
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: UCB Clinical Trials Call Center
Organization: UCB
Phone: +1 877 822 9493
Layout table for additonal information
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT01491113    
Other Study ID Numbers: N01373
First Submitted: December 9, 2011
First Posted: December 13, 2011
Results First Submitted: November 21, 2013
Results First Posted: January 10, 2014
Last Update Posted: February 10, 2014