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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Japan Co. Ltd. )
ClinicalTrials.gov Identifier:
NCT01725009
First received: November 7, 2012
Last updated: March 27, 2013
Last verified: March 2013
  Purpose

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


Condition Intervention Phase
Healthy Volunteers
Drug: Multiple 15-minute intravenous infusions of 1500 mg levetiracetam
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official 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

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    RAUC = AUCτss / AUCτ


Enrollment: 32
Study Start Date: October 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Levetiracetam IV infusions in Japanese
Multiple 15-minute intravenous infusions of 1500 mg levetiracetam in Japanese subjects
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
Experimental: Levetiracetam IV infusions in Caucasian
Multiple 15-minute intravenous infusions of 1500 mg levetiracetam in Caucasian subjects
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

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01725009

Locations
Japan
01
Tokyo, Japan
Sponsors and Collaborators
UCB Japan Co. Ltd.
  More Information

No publications provided

Responsible Party: UCB Pharma ( UCB Japan Co. Ltd. )
ClinicalTrials.gov Identifier: NCT01725009     History of Changes
Other Study ID Numbers: EP0038
Study First Received: November 7, 2012
Last Updated: March 27, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by UCB Pharma:
Healthy volunteers
Japanese
Caucasian

Additional relevant MeSH terms:
Etiracetam
Piracetam
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 16, 2014