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

UCB Japan Co. Ltd.32 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

Multiple 15-minute intravenous infusions of 1500 mg levetiracetamDRUG

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

Eligibility

Sex: MALEMin age: 20 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Tokyo, Japan

Outcomes

Primary Outcomes

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)

Data from ClinicalTrials.gov

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Secondary Outcomes

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)