Clinical trial NCT01491113: Pharmacokinetic (PK) Study in Japanese Non-epileptic Renal Impaired Patients
Official title: Single-Dose Pharmacokinetics of Orally Administered Levetiracetam (LEV) in Japanese Subjects With Normal Renal Function and Various Degrees of Renal Impairment Using a Dosing Regimen Adjusted to Renal Function (250 mg or 500 mg)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy Subjects
Renal Impairments
Keywords: Levetiracetam
Oral administration
Japanese
Non-epileptic
Healthy
Renal impaired subjects
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
Collaborators: name: Parexel
First posted: 2011-12-13
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This is a human pharmacology, single-dose study to investigate the pharmacokinetics of orally administered Levetiracetam (LEV) in Japanese subjects with normal renal function and in Japanese subjects with various degrees of impaired renal function.

Detailed description: The primary objective of this study is to evaluate the plasma and urine PK of Levetiracetam (ucb L059) and its metabolite (ucb L057) after a single dose of LEV 250 mg or LEV 500 mg in Japanese subjects with normal renal function and in Japanese subjects with various degrees of renal impairment.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of Ucb L059 (LEV) for Groups A to D
timeFrame: From Baseline up to 144 hours post first dose
measure: 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
timeFrame: From Baseline up to 144 hours post first dose
measure: Maximum Observed Plasma Concentration (Cmax) of Ucb L057 for Groups A to D
timeFrame: From Baseline up to 144 hours post first dose
measure: Area Under the Concentration-time Curve (AUC(0-t)) of Ucb L057 From Baseline to the Last Quantifiable Concentration for Groups A to D
timeFrame: From Baseline up to 144 hours post first dose
measure: Maximum Observed Plasma Concentration (Cmax) of Ucb L059 (LEV) for Group E During First Period
timeFrame: From Baseline to 44 hours post first dose
measure: Area Under the Concentration-time Curve (AUC(0-t)) of Ucb L059 (LEV) From Baseline to 44 Hours for Group E
timeFrame: From Baseline to 44 hours post first dose
measure: Maximum Observed Plasma Concentration (Cmax) of Ucb L057 for Group E During First Period
timeFrame: From Baseline to 44 hours post first dose
measure: Area Under the Concentration-time Curve (AUC(0-t)) of Ucb L057 From Baseline to 44 Hours for Group E
timeFrame: From Baseline to 44 hours post first dose
Secondary outcomes:
measure: Total Amount Excreted in Urine (Ae) of Ucb L059 (LEV) for Groups A to D
timeFrame: From Baseline up to 144 hours post first dose
measure: Fraction of Dose Excreted in Urine (fe) of Ucb L059 (LEV) for Groups A to D
timeFrame: From Baseline up to 144 hours post first dose
measure: Renal Clearance (CLR) of Ucb L059 (LEV) for Groups A to D
timeFrame: From Baseline up to 144 hours post first dose
measure: Apparent Total Body Clearance (CL/F) of Ucb L059 (LEV) for Groups A to D
timeFrame: From Baseline up to 144 hours post first dose
measure: Nonrenal Clearance (CLNR) of Ucb L059 (LEV) for Groups A to D
timeFrame: From Baseline up to 144 hours post first dose
measure: Total Amount Excreted in Urine (Ae) of Ucb L057 for Groups A to D
timeFrame: From Baseline up to 144 hours post first dose
measure: Renal Clearance (CLR) of Ucb L057 for Groups A to D
timeFrame: From Baseline up to 144 hours post first dose
measure: Apparent Total Body Clearance (CL/F) of Ucb L059 (LEV) for Group E During First Period
timeFrame: From Baseline to 44 hours post first dose
measure: Time to Reach Maximum Plasma Concentration (Tmax) of Ucb L059 (LEV) for Groups A to D
timeFrame: From Baseline up to 144 hours post first dose
measure: Area Under the Concentration-time Curve (AUC) of Ucb L059 (LEV) From Baseline to Infinite for Groups A to D
timeFrame: From Baseline up to 144 hours post first dose
measure: Terminal Half-life (t1/2) of Ucb L059 (LEV) for Groups A to D
timeFrame: From Baseline up to 144 hours post first dose
measure: Time to Reach Maximum Plasma Concentration (Tmax) of Ucb L057 for Groups A to D
timeFrame: From Baseline up to 144 hours post first dose
measure: Area Under the Concentration-time Curve (AUC) of Ucb L057 From Baseline to Infinite for Groups A to D
timeFrame: From Baseline up to 144 hours post first dose
measure: Terminal Half-life (t1/2) of Ucb L057 for Groups A to D
timeFrame: From Baseline up to 144 hours post first dose
measure: Time to Reach Maximum Plasma Concentration (Tmax) of Ucb L059 (Levetiracetam) for Group E During First Period
timeFrame: From Baseline to 44 hours post first dose
measure: Area Under the Concentration-time Curve (AUC) of Ucb L059 (LEV) From Baseline to Infinite for Group E
timeFrame: From Baseline to 140 hours post first dose
measure: Terminal Half-life (t1/2) of Ucb L059 (LEV) for Group E During First Period
timeFrame: From Baseline to 44 hours post first dose
measure: Time to Reach Maximum Plasma Concentration (Tmax) of Ucb L057 for Group E During First Period
timeFrame: From Baseline to 44 hours post first dose
measure: Hemodialysis Clearance (CLD) of Ucb L059 (LEV) During First Dialysis for Group E
timeFrame: From 44 hours to 48 hours post first dose
measure: Ultrafiltration Clearance (CLUF) of Ucb L059 (LEV) During First Dialysis for Group E
timeFrame: From 44 hours to 48 hours post first dose
measure: Hemodialysis Clearance (CLHD) of Ucb L059 (LEV) During First Dialysis for Group E
timeFrame: From 44 hours to 48 hours post first dose
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: 1
city: Ibaraki
country: Japan
facility: 2
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References: