Clinical trial NCT01725009: Multiple-dose Study of Levetiracetam Injection in Japanese and Caucasian Healthy Males
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Healthy volunteers
Japanese
Caucasian
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2012-11-12
Enrollment: 32
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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


Eligibility 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

Primary outcomes:
measure: Maximum plasma concentration after a single dose (Cmax)
timeFrame: 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
measure: Area under the curve from zero to the time of the last quantifiable concentration after a single (AUC(0-t))
timeFrame: 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
measure: Area under the plasma concentration time curve from zero to infinity after a single dose (AUC)
timeFrame: 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
measure: Body-weight normalized maximum plasma concentration after a single dose (Cmax)
timeFrame: 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
measure: Body-weight normalized area under the curve from zero to the time of the last quantifiable concentration after a single, (AUC(0-t))
timeFrame: 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
measure: Body weight normalized area under the plasma concentration time curve from zero to infinity after a single dose, (AUC)
timeFrame: 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
measure: Maximum plasma concentration at steady state after multiple doses (Cmax,ss)
timeFrame: 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.
measure: Area under the curve over a dosing interval at steady state after multiple doses (AUCτss)
timeFrame: 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.
measure: Body-weight normalized maximum plasma concentration at steady state after multiple doses (Cmax,ss)
timeFrame: 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.
measure: Body-weight normalized area under the curve over a dosing interval at steady state after multiple doses (AUCτss)
timeFrame: 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:
measure: Area under the curve over a dosing interval, (AUCτ (τ = 12 hours))
timeFrame: 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
measure: Time to maximum plasma concentration after a single dose (tmax)
timeFrame: 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.
measure: Terminal elimination half-life after a single dose (t1/2)
timeFrame: 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.
measure: First order terminal elimination rate constant after a single dose (λz)
timeFrame: 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.
measure: Total body clearance after a single dose (CL)
timeFrame: 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.
measure: Volume of distribution during terminal phase after a single dose (Vz)
timeFrame: 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.
measure: Mean residence time after a single dose (MRT)
timeFrame: 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.
measure: Time to maximum plasma concentration at steady state after multiple doses (tmax,ss)
timeFrame: 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.
measure: Total body clearance at steady state after multiple doses (CLss)
timeFrame: 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.
measure: Linearity factor after multiple doses (LF)
timeFrame: 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.
measure: Accumulation ratio (RAUC) after multiple doses
timeFrame: 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
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: 01
Study officials:
References: