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Completed

NCT Number: NCT01725009

Multiple-dose Study of Levetiracetam Injection in Japanese and Caucasian Healthy Males

To compare the pharmacokinetics of levetiracetam following single and multiple 15-minute intravenous infusions of 1500 mg levetiracetam between Japanese and Caucasian healthy male subjects

Completed

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Key information

Conditions

Healthy Volunteers

Age range

20 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

01

Tokyo, Japan

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • healthy Japanese and Caucasian males with the age between 20 and 40 years old,
  • with the body mass index between 20 and 25,
  • with the body weight between 60 and 80kg

Exclusion criteria

  • subjects who have a history or presence of drug addiction or excessive use of alcohol
  • current smokers and former smokers who have given up since less than 6 months before the first dose
  • heavy caffeine drinker

Treatment and study plan

Multiple 15-minute intravenous infusions of 1500 mg levetiracetam

Drug

Strength, 100 mg/mL; Form, concentrate for solution for infusion; Frequency, twice a day; Duration, 7 days

Other names: E-Keppra

Primary outcomes

  1. Maximum plasma concentration after a single dose (Cmax)

    Time frame: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of Intravenous (IV) infusion

  2. Area under the curve from zero to the time of the last quantifiable concentration after a single (AUC(0-t))

    Time frame: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion

  3. Area under the plasma concentration time curve from zero to infinity after a single dose (AUC)

    Time frame: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion

  4. Body-weight normalized maximum plasma concentration after a single dose (Cmax)

    Time frame: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion

  5. Body-weight normalized area under the curve from zero to the time of the last quantifiable concentration after a single, (AUC(0-t))

    Time frame: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion

  6. Body weight normalized area under the plasma concentration time curve from zero to infinity after a single dose, (AUC)

    Time frame: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion

  7. Maximum plasma concentration at steady state after multiple doses (Cmax,ss)

    Time frame: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9 and 12 hours after the start of IV infusion.

  8. Area under the curve over a dosing interval at steady state after multiple doses (AUCτss)

    Time frame: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9 and 12 hours after the start of IV infusion.

  9. Body-weight normalized maximum plasma concentration at steady state after multiple doses (Cmax,ss)

    Time frame: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9 and 12 hours after the start of IV infusion.

  10. Body-weight normalized area under the curve over a dosing interval at steady state after multiple doses (AUCτss)

    Time frame: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9 and 12 hours after the start of IV infusion.

Secondary outcomes

  1. Area under the curve over a dosing interval, (AUCτ (τ = 12 hours))

    Time frame: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9 and 12 hours after the start of IV infusion

  2. Time to maximum plasma concentration after a single dose (tmax)

    Time frame: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion.

  3. Terminal elimination half-life after a single dose (t1/2)

    Time frame: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion.

  4. First order terminal elimination rate constant after a single dose (λz)

    Time frame: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion.

  5. Total body clearance after a single dose (CL)

    Time frame: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion.

  6. Volume of distribution during terminal phase after a single dose (Vz)

    Time frame: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion.

  7. Mean residence time after a single dose (MRT)

    Time frame: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion.

  8. Time to maximum plasma concentration at steady state after multiple doses (tmax,ss)

    Time frame: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9 and 12 hours after the start of IV infusion.

  9. Total body clearance at steady state after multiple doses (CLss)

    Time frame: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9 and 12 hours after the start of IV infusion.

  10. Linearity factor after multiple doses (LF)

    Time frame: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of the first IV infusion and at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9 and 12 hours after the start of the last IV infusion.

    LF = AUCτss / AUC

  11. Accumulation ratio (RAUC) after multiple doses

    Time frame: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9 and 12 hours after the start of the first and the last IV infusions

    RAUC = AUCτss / AUCτ

Sponsors and collaborators

Lead sponsor

UCB Japan Co. Ltd.

Industry

Registry information

Official study title

A Single-center, Open-label, Multiple-dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Levetiracetam Administered as Intravenous Infusion in Japanese and Caucasian Healthy Male Subjects

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Nov 12, 2012
Registry last updated
Mar 29, 2013

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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