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

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ClinicalTrials.gov Identifier: NCT01725009
Recruitment Status : Completed
First Posted : November 12, 2012
Last Update Posted : March 29, 2013
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Japan Co. Ltd. )

Tracking Information
First Submitted Date  ICMJE November 7, 2012
First Posted Date  ICMJE November 12, 2012
Last Update Posted Date March 29, 2013
Study Start Date  ICMJE October 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 9, 2012)
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01725009 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 9, 2012)
  • 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 ]
  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Multiple-dose Study of Levetiracetam Injection in Japanese and Caucasian Healthy Males
Official Title  ICMJE 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
Brief Summary 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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE Drug: Multiple 15-minute intravenous infusions of 1500 mg levetiracetam
Strength, 100 mg/mL; Form, concentrate for solution for infusion; Frequency, twice a day; Duration, 7 days
Other Name: E-Keppra
Study Arms  ICMJE
  • Experimental: Levetiracetam IV infusions in Japanese
    Multiple 15-minute intravenous infusions of 1500 mg levetiracetam in Japanese subjects
    Intervention: Drug: Multiple 15-minute intravenous infusions of 1500 mg levetiracetam
  • Experimental: Levetiracetam IV infusions in Caucasian
    Multiple 15-minute intravenous infusions of 1500 mg levetiracetam in Caucasian subjects
    Intervention: Drug: Multiple 15-minute intravenous infusions of 1500 mg levetiracetam
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 27, 2013)
32
Original Estimated Enrollment  ICMJE
 (submitted: November 9, 2012)
50
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01725009
Other Study ID Numbers  ICMJE EP0038
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party UCB Pharma ( UCB Japan Co. Ltd. )
Study Sponsor  ICMJE UCB Japan Co. Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account UCB Pharma
Verification Date March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP