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Completed

NCT Number: NCT01491113

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

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.

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Key information

Conditions

Healthy Subjects Renal Impairments

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

1, Fukuoka, Japan

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Levetiracetam 250 mg

Drug

Tablet containing Levetiracetam 250 mg

Other names: E-Keppra

Levetiracetam 500 mg

Drug

Tablet containing Levetiracetam 500 mg

Other names: E-Keppra

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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).

  6. 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.

  7. 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.

  8. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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 %.

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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).

  16. 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 %.

  17. 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 %.

  18. 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).

  19. 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.

  20. 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.

  21. 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.

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Collaborators

  • Parexel

Registry information

Official study 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)

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 13, 2011
Registry last updated
Feb 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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