- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01491113
Pharmacokinetic (PK) Study in Japanese Non-epileptic Renal Impaired Patients
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
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Fukuoka, Japan
- 1
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Ibaraki, Japan
- 2
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group A: Normal renal function
Subjects who have normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects will be orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings will be taken through to Day 4 during the Treatment Period, and safety follow-up assessments will be performed on Day 8 according to the schedule of study assessments.
|
Tablet containing Levetiracetam 500 mg
Other Names:
|
Experimental: Group B: Mild renal impairment
Patients who have mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects will be orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings will be conducted through Day 5 during the Treatment Period, and safety follow-up assessments will be performed on Day 8 according to the schedule of study assessments.
|
Tablet containing Levetiracetam 500 mg
Other Names:
|
Experimental: Group C: Moderate renal impairment
Patients who have moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects will be orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings will be conducted through Day 6 during the Treatment Period, and safety follow-up assessments will be performed on Day 8 according to the schedule of study assessments.
|
Tablet containing Levetiracetam 250 mg
Other Names:
|
Experimental: Group D: Severe renal impairment
Patients who have severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects will be orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings will be conducted through Day 7 during the Treatment Period, and safety follow-up assessments will be performed on Day 8 according to the schedule of study assessments.
|
Tablet containing Levetiracetam 250 mg
Other Names:
|
Experimental: Group E: End-stage renal disease
Group E will receive Levetiracetam (LEV) 500 mg on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg will be administered 1 h after the end of the first hemodialysis on Day 3. The 4-h Hemodialysis are scheduled as follows:
Safety assessments and blood samplings will be conducted until Day 7. Safety follow-up assessments will be performed on Day 10. Blood samples for Pharmacokinetics (PK): Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 30, 44*, 44.25*, 44.5*, 45*, 46*, 47*, 48*, 49, 49.5, 50, 51, 53, 55, 57, 61, 73, 92, 96, 120, 140 hours post first dosing. 49 h-sample should be taken before the additional dose. The 44 h, 92 h, and 140 h sample should be taken before the start of the hemodialysis. *Inflow blood, outflow blood, and dialysate fluid will be collected. |
Tablet containing Levetiracetam 500 mg
Other Names:
Tablet containing Levetiracetam 250 mg
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum Observed Plasma Concentration (Cmax) of Ucb L059 (LEV) for Groups A to D
Time Frame: From Baseline up to 144 hours post first dose
|
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 |
From Baseline up to 144 hours post first dose
|
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
Time Frame: From Baseline up to 144 hours post first dose
|
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 |
From Baseline up to 144 hours post first dose
|
Maximum Observed Plasma Concentration (Cmax) of Ucb L057 for Groups A to D
Time Frame: From Baseline up to 144 hours post first dose
|
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 |
From Baseline up to 144 hours post first dose
|
Area Under the Concentration-time Curve (AUC(0-t)) of Ucb L057 From Baseline to the Last Quantifiable Concentration for Groups A to D
Time Frame: From Baseline up to 144 hours post first dose
|
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 |
From Baseline up to 144 hours post first dose
|
Maximum Observed Plasma Concentration (Cmax) of Ucb L059 (LEV) for Group E During First Period
Time Frame: From Baseline to 44 hours post first dose
|
Cmax refers to the maximum observed concentration of ucb L059 (Levetiracetam).
|
From Baseline to 44 hours post first dose
|
Area Under the Concentration-time Curve (AUC(0-t)) of Ucb L059 (LEV) From Baseline to 44 Hours for Group E
Time Frame: From Baseline to 44 hours post first dose
|
AUC(0-t) refers to the area under the plasma concentration versus time curve, which provides information on the exposure.
|
From Baseline to 44 hours post first dose
|
Maximum Observed Plasma Concentration (Cmax) of Ucb L057 for Group E During First Period
Time Frame: From Baseline to 44 hours post first dose
|
Cmax refers to the maximum observed concentration of ucb L057.
|
From Baseline to 44 hours post first dose
|
Area Under the Concentration-time Curve (AUC(0-t)) of Ucb L057 From Baseline to 44 Hours for Group E
Time Frame: From Baseline to 44 hours post first dose
|
AUC(0-t) refers to the area under the plasma concentration versus time curve, which provides information on the exposure.
|
From Baseline to 44 hours post first dose
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total Amount Excreted in Urine (Ae) of Ucb L059 (LEV) for Groups A to D
Time Frame: From Baseline up to 144 hours post first dose
|
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 |
From Baseline up to 144 hours post first dose
|
Fraction of Dose Excreted in Urine (fe) of Ucb L059 (LEV) for Groups A to D
Time Frame: From Baseline up to 144 hours post first dose
|
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 |
From Baseline up to 144 hours post first dose
|
Renal Clearance (CLR) of Ucb L059 (LEV) for Groups A to D
Time Frame: From Baseline up to 144 hours post first dose
|
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 |
From Baseline up to 144 hours post first dose
|
Apparent Total Body Clearance (CL/F) of Ucb L059 (LEV) for Groups A to D
Time Frame: From Baseline up to 144 hours post first dose
|
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 |
From Baseline up to 144 hours post first dose
|
Nonrenal Clearance (CLNR) of Ucb L059 (LEV) for Groups A to D
Time Frame: From Baseline up to 144 hours post first dose
|
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 |
From Baseline up to 144 hours post first dose
|
Total Amount Excreted in Urine (Ae) of Ucb L057 for Groups A to D
Time Frame: From Baseline up to 144 hours post first dose
|
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 |
From Baseline up to 144 hours post first dose
|
Renal Clearance (CLR) of Ucb L057 for Groups A to D
Time Frame: From Baseline up to 144 hours post first dose
|
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 |
From Baseline up to 144 hours post first dose
|
Apparent Total Body Clearance (CL/F) of Ucb L059 (LEV) for Group E During First Period
Time Frame: From Baseline to 44 hours post first dose
|
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 %. |
From Baseline to 44 hours post first dose
|
Time to Reach Maximum Plasma Concentration (Tmax) of Ucb L059 (LEV) for Groups A to D
Time Frame: From Baseline up to 144 hours post first dose
|
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 |
From Baseline up to 144 hours post first dose
|
Area Under the Concentration-time Curve (AUC) of Ucb L059 (LEV) From Baseline to Infinite for Groups A to D
Time Frame: From Baseline up to 144 hours post first dose
|
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 |
From Baseline up to 144 hours post first dose
|
Terminal Half-life (t1/2) of Ucb L059 (LEV) for Groups A to D
Time Frame: From Baseline up to 144 hours post first dose
|
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 |
From Baseline up to 144 hours post first dose
|
Time to Reach Maximum Plasma Concentration (Tmax) of Ucb L057 for Groups A to D
Time Frame: From Baseline up to 144 hours post first dose
|
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 |
From Baseline up to 144 hours post first dose
|
Area Under the Concentration-time Curve (AUC) of Ucb L057 From Baseline to Infinite for Groups A to D
Time Frame: From Baseline up to 144 hours post first dose
|
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 |
From Baseline up to 144 hours post first dose
|
Terminal Half-life (t1/2) of Ucb L057 for Groups A to D
Time Frame: From Baseline up to 144 hours post first dose
|
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 |
From Baseline up to 144 hours post first dose
|
Time to Reach Maximum Plasma Concentration (Tmax) of Ucb L059 (Levetiracetam) for Group E During First Period
Time Frame: From Baseline to 44 hours post first dose
|
tmax refers to the time to reach the maximum plasma concentration of ucb L059 (Levetiracetam).
|
From Baseline to 44 hours post first dose
|
Area Under the Concentration-time Curve (AUC) of Ucb L059 (LEV) From Baseline to Infinite for Group E
Time Frame: From Baseline to 140 hours post first dose
|
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 %. |
From Baseline to 140 hours post first dose
|
Terminal Half-life (t1/2) of Ucb L059 (LEV) for Group E During First Period
Time Frame: From Baseline to 44 hours post first dose
|
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 %. |
From Baseline to 44 hours post first dose
|
Time to Reach Maximum Plasma Concentration (Tmax) of Ucb L057 for Group E During First Period
Time Frame: From Baseline to 44 hours post first dose
|
tmax refers to the time to reach maximum plasma concentration (tmax).
|
From Baseline to 44 hours post first dose
|
Hemodialysis Clearance (CLD) of Ucb L059 (LEV) During First Dialysis for Group E
Time Frame: From 44 hours to 48 hours post first dose
|
Calculated by the Arterio - Venous difference method and cumulative dialysate method.
|
From 44 hours to 48 hours post first dose
|
Ultrafiltration Clearance (CLUF) of Ucb L059 (LEV) During First Dialysis for Group E
Time Frame: From 44 hours to 48 hours post first dose
|
Calculated by the Arterio - Venous difference method and cumulative dialysate method.
|
From 44 hours to 48 hours post first dose
|
Hemodialysis Clearance (CLHD) of Ucb L059 (LEV) During First Dialysis for Group E
Time Frame: From 44 hours to 48 hours post first dose
|
Calculated according: CLHD=CLD+CLUF.
|
From 44 hours to 48 hours post first dose
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- N01373
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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