Trial Outcomes & Findings for Pharmacokinetic (PK) Study in Japanese Non-epileptic Renal Impaired Patients (NCT NCT01491113)
NCT ID: NCT01491113
Last Updated: 2014-02-10
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
30 participants
Primary outcome timeframe
From Baseline up to 144 hours post first dose
Results posted on
2014-02-10
Participant Flow
The Participant Flow refers to the Safety Set population which includes all patients that received at least one dose of study medication.
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).
Participant milestones
| Measure |
Group A: Normal Renal Function
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
|
Group B: Mild Renal Impairment
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
|
Group C: Moderate Renal Impairment
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
|
Group D: Severe Renal Impairment
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: End-stage Renal Disease
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.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacokinetic (PK) Study in Japanese Non-epileptic Renal Impaired Patients
Baseline characteristics by cohort
| Measure |
Group A: Normal Renal Function
n=6 Participants
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
|
Group B: Mild Renal Impairment
n=6 Participants
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
|
Group C: Moderate Renal Impairment
n=6 Participants
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
|
Group D: Severe Renal Impairment
n=6 Participants
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: End-stage Renal Disease
n=6 Participants
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
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
61.7 years
STANDARD_DEVIATION 2.6 • n=5 Participants
|
67.5 years
STANDARD_DEVIATION 5.0 • n=7 Participants
|
69.3 years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
55.8 years
STANDARD_DEVIATION 17.1 • n=4 Participants
|
68.8 years
STANDARD_DEVIATION 7.9 • n=21 Participants
|
64.6 years
STANDARD_DEVIATION 10.0 • n=8 Participants
|
|
Age, Customized
20 - <65 years
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
1 participants
n=5 Participants
|
4 participants
n=4 Participants
|
2 participants
n=21 Participants
|
15 participants
n=8 Participants
|
|
Age, Customized
>=65 years
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
2 participants
n=4 Participants
|
4 participants
n=21 Participants
|
15 participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
29 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
6 participants
n=4 Participants
|
6 participants
n=21 Participants
|
30 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
6 participants
n=4 Participants
|
6 participants
n=21 Participants
|
30 participants
n=8 Participants
|
|
Weight
|
60.95 kilogram
STANDARD_DEVIATION 10.97 • n=5 Participants
|
74.28 kilogram
STANDARD_DEVIATION 4.14 • n=7 Participants
|
63.07 kilogram
STANDARD_DEVIATION 12.49 • n=5 Participants
|
58.70 kilogram
STANDARD_DEVIATION 6.10 • n=4 Participants
|
62.20 kilogram
STANDARD_DEVIATION 5.41 • n=21 Participants
|
63.84 kilogram
STANDARD_DEVIATION 9.62 • n=8 Participants
|
|
Height
|
161.73 centimeters
STANDARD_DEVIATION 9.05 • n=5 Participants
|
165.65 centimeters
STANDARD_DEVIATION 3.11 • n=7 Participants
|
163.72 centimeters
STANDARD_DEVIATION 5.64 • n=5 Participants
|
164.50 centimeters
STANDARD_DEVIATION 6.34 • n=4 Participants
|
162.38 centimeters
STANDARD_DEVIATION 3.41 • n=21 Participants
|
163.60 centimeters
STANDARD_DEVIATION 5.68 • n=8 Participants
|
PRIMARY outcome
Timeframe: From Baseline up to 144 hours post first dosePopulation: 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.
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
Outcome measures
| Measure |
Group A: Normal Renal Function
n=6 Participants
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
|
Group B: Mild Renal Impairment
n=6 Participants
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
|
Group C: Moderate Renal Impairment
n=6 Participants
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
|
Group D: Severe Renal Impairment
n=6 Participants
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
|
|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Ucb L059 (LEV) for Groups A to D
|
21.9357 µg/mL
Geometric Coefficient of Variation 31.2
|
15.5334 µg/mL
Geometric Coefficient of Variation 25.3
|
10.7767 µg/mL
Geometric Coefficient of Variation 24.3
|
9.1754 µg/mL
Geometric Coefficient of Variation 30.4
|
PRIMARY outcome
Timeframe: From Baseline up to 144 hours post first dosePopulation: 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.
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
Outcome measures
| Measure |
Group A: Normal Renal Function
n=6 Participants
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
|
Group B: Mild Renal Impairment
n=6 Participants
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
|
Group C: Moderate Renal Impairment
n=6 Participants
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
|
Group D: Severe Renal Impairment
n=6 Participants
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
|
|---|---|---|---|---|
|
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
|
165.9996 h*µg/mL
Geometric Coefficient of Variation 16.5
|
247.6430 h*µg/mL
Geometric Coefficient of Variation 16.9
|
169.3392 h*µg/mL
Geometric Coefficient of Variation 16.5
|
212.1193 h*µg/mL
Geometric Coefficient of Variation 19.1
|
PRIMARY outcome
Timeframe: From Baseline up to 144 hours post first dosePopulation: 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.
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
Outcome measures
| Measure |
Group A: Normal Renal Function
n=6 Participants
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
|
Group B: Mild Renal Impairment
n=6 Participants
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
|
Group C: Moderate Renal Impairment
n=6 Participants
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
|
Group D: Severe Renal Impairment
n=6 Participants
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
|
|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Ucb L057 for Groups A to D
|
0.3620 µg/mL
Geometric Coefficient of Variation 9.4
|
0.7503 µg/mL
Geometric Coefficient of Variation 25.8
|
0.5674 µg/mL
Geometric Coefficient of Variation 26.0
|
1.0640 µg/mL
Geometric Coefficient of Variation 29.3
|
PRIMARY outcome
Timeframe: From Baseline up to 144 hours post first dosePopulation: 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.
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
Outcome measures
| Measure |
Group A: Normal Renal Function
n=6 Participants
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
|
Group B: Mild Renal Impairment
n=6 Participants
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
|
Group C: Moderate Renal Impairment
n=6 Participants
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
|
Group D: Severe Renal Impairment
n=6 Participants
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
|
|---|---|---|---|---|
|
Area Under the Concentration-time Curve (AUC(0-t)) of Ucb L057 From Baseline to the Last Quantifiable Concentration for Groups A to D
|
5.8607 h*µg/mL
Geometric Coefficient of Variation 9.7
|
22.5573 h*µg/mL
Geometric Coefficient of Variation 45.9
|
18.6675 h*µg/mL
Geometric Coefficient of Variation 53.4
|
57.7773 h*µg/mL
Geometric Coefficient of Variation 57.3
|
PRIMARY outcome
Timeframe: From Baseline to 44 hours post first dosePopulation: 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.
Cmax refers to the maximum observed concentration of ucb L059 (Levetiracetam).
Outcome measures
| Measure |
Group A: Normal Renal Function
n=6 Participants
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
|
Group B: Mild Renal Impairment
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
|
Group C: Moderate Renal Impairment
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
|
Group D: Severe Renal Impairment
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
|
|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Ucb L059 (LEV) for Group E During First Period
|
18.6810 µg/mL
Geometric Coefficient of Variation 8.1
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From Baseline to 44 hours post first dosePopulation: 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.
AUC(0-t) refers to the area under the plasma concentration versus time curve, which provides information on the exposure.
Outcome measures
| Measure |
Group A: Normal Renal Function
n=6 Participants
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
|
Group B: Mild Renal Impairment
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
|
Group C: Moderate Renal Impairment
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
|
Group D: Severe Renal Impairment
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
|
|---|---|---|---|---|
|
Area Under the Concentration-time Curve (AUC(0-t)) of Ucb L059 (LEV) From Baseline to 44 Hours for Group E
|
462.4883 h*µg/mL
Geometric Coefficient of Variation 10.5
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From Baseline to 44 hours post first dosePopulation: 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.
Cmax refers to the maximum observed concentration of ucb L057.
Outcome measures
| Measure |
Group A: Normal Renal Function
n=6 Participants
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
|
Group B: Mild Renal Impairment
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
|
Group C: Moderate Renal Impairment
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
|
Group D: Severe Renal Impairment
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
|
|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Ucb L057 for Group E During First Period
|
8.8435 µg/mL
Geometric Coefficient of Variation 7.0
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From Baseline to 44 hours post first dosePopulation: 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.
AUC(0-t) refers to the area under the plasma concentration versus time curve, which provides information on the exposure.
Outcome measures
| Measure |
Group A: Normal Renal Function
n=6 Participants
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
|
Group B: Mild Renal Impairment
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
|
Group C: Moderate Renal Impairment
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
|
Group D: Severe Renal Impairment
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
|
|---|---|---|---|---|
|
Area Under the Concentration-time Curve (AUC(0-t)) of Ucb L057 From Baseline to 44 Hours for Group E
|
230.4393 h*µg/mL
Geometric Coefficient of Variation 7.8
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Baseline up to 144 hours post first dosePopulation: 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.
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
Outcome measures
| Measure |
Group A: Normal Renal Function
n=4 Participants
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
|
Group B: Mild Renal Impairment
n=6 Participants
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
|
Group C: Moderate Renal Impairment
n=6 Participants
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
|
Group D: Severe Renal Impairment
n=6 Participants
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
|
|---|---|---|---|---|
|
Total Amount Excreted in Urine (Ae) of Ucb L059 (LEV) for Groups A to D
|
304.7321 mg
Geometric Coefficient of Variation 30.3
|
247.6562 mg
Geometric Coefficient of Variation 12.5
|
98.7182 mg
Geometric Coefficient of Variation 11.9
|
74.3761 mg
Geometric Coefficient of Variation 34.4
|
SECONDARY outcome
Timeframe: From Baseline up to 144 hours post first dosePopulation: 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.
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
Outcome measures
| Measure |
Group A: Normal Renal Function
n=4 Participants
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
|
Group B: Mild Renal Impairment
n=6 Participants
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
|
Group C: Moderate Renal Impairment
n=6 Participants
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
|
Group D: Severe Renal Impairment
n=6 Participants
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
|
|---|---|---|---|---|
|
Fraction of Dose Excreted in Urine (fe) of Ucb L059 (LEV) for Groups A to D
|
60.9464 Percentage of Dose Administered
Geometric Coefficient of Variation 30.3
|
49.5312 Percentage of Dose Administered
Geometric Coefficient of Variation 12.5
|
39.4873 Percentage of Dose Administered
Geometric Coefficient of Variation 11.9
|
29.7504 Percentage of Dose Administered
Geometric Coefficient of Variation 34.4
|
SECONDARY outcome
Timeframe: From Baseline up to 144 hours post first dosePopulation: 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.
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
Outcome measures
| Measure |
Group A: Normal Renal Function
n=4 Participants
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
|
Group B: Mild Renal Impairment
n=6 Participants
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
|
Group C: Moderate Renal Impairment
n=6 Participants
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
|
Group D: Severe Renal Impairment
n=6 Participants
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
|
|---|---|---|---|---|
|
Renal Clearance (CLR) of Ucb L059 (LEV) for Groups A to D
|
1.8622 L/h
Geometric Coefficient of Variation 27.4
|
0.9820 L/h
Geometric Coefficient of Variation 22.1
|
0.5671 L/h
Geometric Coefficient of Variation 17.6
|
0.3417 L/h
Geometric Coefficient of Variation 49.3
|
SECONDARY outcome
Timeframe: From Baseline up to 144 hours post first dosePopulation: 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.
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
Outcome measures
| Measure |
Group A: Normal Renal Function
n=6 Participants
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
|
Group B: Mild Renal Impairment
n=6 Participants
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
|
Group C: Moderate Renal Impairment
n=6 Participants
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
|
Group D: Severe Renal Impairment
n=6 Participants
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
|
|---|---|---|---|---|
|
Apparent Total Body Clearance (CL/F) of Ucb L059 (LEV) for Groups A to D
|
2.9359 L/h
Geometric Coefficient of Variation 14.8
|
1.9826 L/h
Geometric Coefficient of Variation 16.0
|
1.4362 L/h
Geometric Coefficient of Variation 15.3
|
1.1484 L/h
Geometric Coefficient of Variation 19.1
|
SECONDARY outcome
Timeframe: From Baseline up to 144 hours post first dosePopulation: 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.
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
Outcome measures
| Measure |
Group A: Normal Renal Function
n=4 Participants
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
|
Group B: Mild Renal Impairment
n=6 Participants
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
|
Group C: Moderate Renal Impairment
n=6 Participants
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
|
Group D: Severe Renal Impairment
n=6 Participants
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
|
|---|---|---|---|---|
|
Nonrenal Clearance (CLNR) of Ucb L059 (LEV) for Groups A to D
|
1.0712 L/h
Geometric Coefficient of Variation 50.6
|
0.9873 L/h
Geometric Coefficient of Variation 17.4
|
0.8636 L/h
Geometric Coefficient of Variation 18.4
|
0.7848 L/h
Geometric Coefficient of Variation 17.9
|
SECONDARY outcome
Timeframe: From Baseline up to 144 hours post first dosePopulation: 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.
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
Outcome measures
| Measure |
Group A: Normal Renal Function
n=4 Participants
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
|
Group B: Mild Renal Impairment
n=6 Participants
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
|
Group C: Moderate Renal Impairment
n=6 Participants
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
|
Group D: Severe Renal Impairment
n=6 Participants
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
|
|---|---|---|---|---|
|
Total Amount Excreted in Urine (Ae) of Ucb L057 for Groups A to D
|
83.5936 mg
Geometric Coefficient of Variation 16.9
|
169.3395 mg
Geometric Coefficient of Variation 19.0
|
93.1346 mg
Geometric Coefficient of Variation 14.0
|
100.7489 mg
Geometric Coefficient of Variation 17.8
|
SECONDARY outcome
Timeframe: From Baseline up to 144 hours post first dosePopulation: 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.
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
Outcome measures
| Measure |
Group A: Normal Renal Function
n=4 Participants
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
|
Group B: Mild Renal Impairment
n=6 Participants
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
|
Group C: Moderate Renal Impairment
n=6 Participants
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
|
Group D: Severe Renal Impairment
n=6 Participants
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
|
|---|---|---|---|---|
|
Renal Clearance (CLR) of Ucb L057 for Groups A to D
|
14.6937 L/h
Geometric Coefficient of Variation 18.3
|
6.8015 L/h
Geometric Coefficient of Variation 32.6
|
4.6828 L/h
Geometric Coefficient of Variation 45.6
|
1.6475 L/h
Geometric Coefficient of Variation 42.0
|
SECONDARY outcome
Timeframe: From Baseline to 44 hours post first dosePopulation: 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.
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 %.
Outcome measures
| Measure |
Group A: Normal Renal Function
n=6 Participants
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
|
Group B: Mild Renal Impairment
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
|
Group C: Moderate Renal Impairment
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
|
Group D: Severe Renal Impairment
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
|
|---|---|---|---|---|
|
Apparent Total Body Clearance (CL/F) of Ucb L059 (LEV) for Group E During First Period
|
0.629 L/h
Interval 0.5 to 0.801
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Baseline up to 144 hours post first dosePopulation: 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.
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
Outcome measures
| Measure |
Group A: Normal Renal Function
n=6 Participants
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
|
Group B: Mild Renal Impairment
n=6 Participants
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
|
Group C: Moderate Renal Impairment
n=6 Participants
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
|
Group D: Severe Renal Impairment
n=6 Participants
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
|
|---|---|---|---|---|
|
Time to Reach Maximum Plasma Concentration (Tmax) of Ucb L059 (LEV) for Groups A to D
|
0.500 hours
Interval 0.5 to 2.0
|
1.000 hours
Interval 0.5 to 2.0
|
0.500 hours
Interval 0.5 to 1.0
|
0.500 hours
Interval 0.5 to 1.0
|
SECONDARY outcome
Timeframe: From Baseline up to 144 hours post first dosePopulation: 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.
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
Outcome measures
| Measure |
Group A: Normal Renal Function
n=6 Participants
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
|
Group B: Mild Renal Impairment
n=6 Participants
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
|
Group C: Moderate Renal Impairment
n=6 Participants
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
|
Group D: Severe Renal Impairment
n=6 Participants
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
|
|---|---|---|---|---|
|
Area Under the Concentration-time Curve (AUC) of Ucb L059 (LEV) From Baseline to Infinite for Groups A to D
|
170.3045 h*µg/mL
Geometric Coefficient of Variation 14.8
|
252.1923 h*µg/mL
Geometric Coefficient of Variation 16.0
|
174.0764 h*µg/mL
Geometric Coefficient of Variation 15.3
|
217.6854 h*µg/mL
Geometric Coefficient of Variation 19.1
|
SECONDARY outcome
Timeframe: From Baseline up to 144 hours post first dosePopulation: 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.
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
Outcome measures
| Measure |
Group A: Normal Renal Function
n=6 Participants
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
|
Group B: Mild Renal Impairment
n=6 Participants
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
|
Group C: Moderate Renal Impairment
n=6 Participants
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
|
Group D: Severe Renal Impairment
n=6 Participants
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
|
|---|---|---|---|---|
|
Terminal Half-life (t1/2) of Ucb L059 (LEV) for Groups A to D
|
7.6164 hours
Geometric Coefficient of Variation 6.9
|
12.6214 hours
Geometric Coefficient of Variation 11.3
|
15.5033 hours
Geometric Coefficient of Variation 17.5
|
19.7320 hours
Geometric Coefficient of Variation 26.5
|
SECONDARY outcome
Timeframe: From Baseline up to 144 hours post first dosePopulation: 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.
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
Outcome measures
| Measure |
Group A: Normal Renal Function
n=6 Participants
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
|
Group B: Mild Renal Impairment
n=6 Participants
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
|
Group C: Moderate Renal Impairment
n=6 Participants
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
|
Group D: Severe Renal Impairment
n=6 Participants
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
|
|---|---|---|---|---|
|
Time to Reach Maximum Plasma Concentration (Tmax) of Ucb L057 for Groups A to D
|
5.000 hours
Interval 2.0 to 8.0
|
8.000 hours
Interval 6.0 to 12.0
|
12.000 hours
Interval 8.0 to 12.0
|
24.000 hours
Interval 12.0 to 24.0
|
SECONDARY outcome
Timeframe: From Baseline up to 144 hours post first dosePopulation: 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.
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
Outcome measures
| Measure |
Group A: Normal Renal Function
n=5 Participants
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
|
Group B: Mild Renal Impairment
n=4 Participants
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
|
Group C: Moderate Renal Impairment
n=4 Participants
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
|
Group D: Severe Renal Impairment
n=4 Participants
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
|
|---|---|---|---|---|
|
Area Under the Concentration-time Curve (AUC) of Ucb L057 From Baseline to Infinite for Groups A to D
|
8.176 h*µg/mL
Full Range 0 • Interval 7.432 to 11.085
|
32.401 h*µg/mL
Interval 28.91 to 38.917
|
27.441 h*µg/mL
Interval 16.472 to 41.184
|
63.126 h*µg/mL
Interval 48.016 to 171.348
|
SECONDARY outcome
Timeframe: From Baseline up to 144 hours post first dosePopulation: 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.
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
Outcome measures
| Measure |
Group A: Normal Renal Function
n=5 Participants
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
|
Group B: Mild Renal Impairment
n=4 Participants
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
|
Group C: Moderate Renal Impairment
n=4 Participants
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
|
Group D: Severe Renal Impairment
n=4 Participants
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
|
|---|---|---|---|---|
|
Terminal Half-life (t1/2) of Ucb L057 for Groups A to D
|
12.351 hours
Interval 11.348 to 15.31
|
19.030 hours
Interval 17.331 to 19.903
|
20.303 hours
Interval 19.681 to 23.569
|
26.769 hours
Interval 17.249 to 33.348
|
SECONDARY outcome
Timeframe: From Baseline to 44 hours post first dosePopulation: 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.
tmax refers to the time to reach the maximum plasma concentration of ucb L059 (Levetiracetam).
Outcome measures
| Measure |
Group A: Normal Renal Function
n=6 Participants
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
|
Group B: Mild Renal Impairment
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
|
Group C: Moderate Renal Impairment
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
|
Group D: Severe Renal Impairment
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
|
|---|---|---|---|---|
|
Time to Reach Maximum Plasma Concentration (Tmax) of Ucb L059 (Levetiracetam) for Group E During First Period
|
0.720 hours
Interval 0.43 to 0.98
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Baseline to 140 hours post first dosePopulation: 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.
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 %.
Outcome measures
| Measure |
Group A: Normal Renal Function
n=6 Participants
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
|
Group B: Mild Renal Impairment
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
|
Group C: Moderate Renal Impairment
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
|
Group D: Severe Renal Impairment
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
|
|---|---|---|---|---|
|
Area Under the Concentration-time Curve (AUC) of Ucb L059 (LEV) From Baseline to Infinite for Group E
|
794.588 h*µg/mL
Full Range 10.5 • Interval 624.521 to 999.853
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Baseline to 44 hours post first dosePopulation: 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.
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 %.
Outcome measures
| Measure |
Group A: Normal Renal Function
n=6 Participants
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
|
Group B: Mild Renal Impairment
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
|
Group C: Moderate Renal Impairment
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
|
Group D: Severe Renal Impairment
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
|
|---|---|---|---|---|
|
Terminal Half-life (t1/2) of Ucb L059 (LEV) for Group E During First Period
|
34.669 hours
Interval 29.227 to 38.648
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Baseline to 44 hours post first dosePopulation: 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.
tmax refers to the time to reach maximum plasma concentration (tmax).
Outcome measures
| Measure |
Group A: Normal Renal Function
n=6 Participants
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
|
Group B: Mild Renal Impairment
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
|
Group C: Moderate Renal Impairment
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
|
Group D: Severe Renal Impairment
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
|
|---|---|---|---|---|
|
Time to Reach Maximum Plasma Concentration (Tmax) of Ucb L057 for Group E During First Period
|
44.020 hours
Interval 44.0 to 44.03
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From 44 hours to 48 hours post first dosePopulation: 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.
Calculated by the Arterio - Venous difference method and cumulative dialysate method.
Outcome measures
| Measure |
Group A: Normal Renal Function
n=6 Participants
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
|
Group B: Mild Renal Impairment
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
|
Group C: Moderate Renal Impairment
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
|
Group D: Severe Renal Impairment
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
|
|---|---|---|---|---|
|
Hemodialysis Clearance (CLD) of Ucb L059 (LEV) During First Dialysis for Group E
|
113.9665 mL/min
Geometric Coefficient of Variation 8.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From 44 hours to 48 hours post first dosePopulation: 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.
Calculated by the Arterio - Venous difference method and cumulative dialysate method.
Outcome measures
| Measure |
Group A: Normal Renal Function
n=6 Participants
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
|
Group B: Mild Renal Impairment
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
|
Group C: Moderate Renal Impairment
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
|
Group D: Severe Renal Impairment
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
|
|---|---|---|---|---|
|
Ultrafiltration Clearance (CLUF) of Ucb L059 (LEV) During First Dialysis for Group E
|
1.3271 mL/min
Geometric Coefficient of Variation 32.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From 44 hours to 48 hours post first dosePopulation: 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.
Calculated according: CLHD=CLD+CLUF.
Outcome measures
| Measure |
Group A: Normal Renal Function
n=6 Participants
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
|
Group B: Mild Renal Impairment
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
|
Group C: Moderate Renal Impairment
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
|
Group D: Severe Renal Impairment
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
|
|---|---|---|---|---|
|
Hemodialysis Clearance (CLHD) of Ucb L059 (LEV) During First Dialysis for Group E
|
115.3702 mL/min
Geometric Coefficient of Variation 8.1
|
—
|
—
|
—
|
Adverse Events
Group A: Normal Renal Function
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group B: Mild Renal Impairment
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Group C: Moderate Renal Impairment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group D: Severe Renal Impairment
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Group E: End-stage Renal Disease
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group A: Normal Renal Function
n=6 participants at risk
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
|
Group B: Mild Renal Impairment
n=6 participants at risk
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
|
Group C: Moderate Renal Impairment
n=6 participants at risk
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
|
Group D: Severe Renal Impairment
n=6 participants at risk
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: End-stage Renal Disease
n=6 participants at risk
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.
|
|---|---|---|---|---|---|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • 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.
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.
|
0.00%
0/6 • 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.
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.
|
0.00%
0/6 • 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.
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.
|
0.00%
0/6 • 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.
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.
|
16.7%
1/6 • Number of events 1 • 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.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/6 • 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.
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.
|
0.00%
0/6 • 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.
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.
|
0.00%
0/6 • 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.
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.
|
0.00%
0/6 • 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.
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.
|
16.7%
1/6 • Number of events 1 • 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.
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.
|
|
Injury, poisoning and procedural complications
Shunt malfunction
|
0.00%
0/6 • 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.
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.
|
0.00%
0/6 • 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.
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.
|
0.00%
0/6 • 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.
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.
|
0.00%
0/6 • 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.
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.
|
16.7%
1/6 • Number of events 1 • 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.
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.
|
Other adverse events
| Measure |
Group A: Normal Renal Function
n=6 participants at risk
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
|
Group B: Mild Renal Impairment
n=6 participants at risk
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
|
Group C: Moderate Renal Impairment
n=6 participants at risk
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
|
Group D: Severe Renal Impairment
n=6 participants at risk
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: End-stage Renal Disease
n=6 participants at risk
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.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Gingivitis
|
0.00%
0/6 • 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.
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.
|
16.7%
1/6 • Number of events 1 • 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.
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.
|
0.00%
0/6 • 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.
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.
|
0.00%
0/6 • 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.
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.
|
0.00%
0/6 • 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.
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.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/6 • 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.
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.
|
16.7%
1/6 • Number of events 1 • 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.
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.
|
0.00%
0/6 • 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.
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.
|
0.00%
0/6 • 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.
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.
|
0.00%
0/6 • 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.
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.
|
|
General disorders
Pyrexia
|
0.00%
0/6 • 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.
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.
|
16.7%
1/6 • Number of events 1 • 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.
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.
|
0.00%
0/6 • 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.
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.
|
0.00%
0/6 • 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.
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.
|
0.00%
0/6 • 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.
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.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • 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.
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.
|
0.00%
0/6 • 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.
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.
|
0.00%
0/6 • 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.
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.
|
16.7%
1/6 • Number of events 1 • 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.
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.
|
0.00%
0/6 • 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.
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.
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
0.00%
0/6 • 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.
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.
|
0.00%
0/6 • 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.
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.
|
0.00%
0/6 • 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.
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.
|
0.00%
0/6 • 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.
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.
|
16.7%
1/6 • Number of events 1 • 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.
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.
|
|
Investigations
White blood cell count increased
|
0.00%
0/6 • 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.
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.
|
0.00%
0/6 • 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.
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.
|
0.00%
0/6 • 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.
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.
|
0.00%
0/6 • 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.
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.
|
16.7%
1/6 • Number of events 1 • 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.
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.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/6 • 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.
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.
|
0.00%
0/6 • 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.
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.
|
0.00%
0/6 • 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.
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.
|
0.00%
0/6 • 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.
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.
|
16.7%
1/6 • Number of events 1 • 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.
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.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • 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.
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.
|
0.00%
0/6 • 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.
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.
|
0.00%
0/6 • 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.
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.
|
0.00%
0/6 • 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.
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.
|
16.7%
1/6 • Number of events 1 • 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.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • 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.
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.
|
0.00%
0/6 • 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.
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.
|
0.00%
0/6 • 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.
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.
|
0.00%
0/6 • 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.
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.
|
16.7%
1/6 • Number of events 1 • 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.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/6 • 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.
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.
|
0.00%
0/6 • 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.
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.
|
0.00%
0/6 • 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.
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.
|
0.00%
0/6 • 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.
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.
|
16.7%
1/6 • Number of events 1 • 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.
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.
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • 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.
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.
|
0.00%
0/6 • 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.
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.
|
0.00%
0/6 • 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.
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.
|
0.00%
0/6 • 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.
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.
|
16.7%
1/6 • Number of events 1 • 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.
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.
|
Additional Information
UCB Clinical Trials Call Center
UCB
Phone: +1 877 822 9493
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60