Multiple-dose Study of Levetiracetam Injection in Japanese and Caucasian Healthy Males
Phase 1
Completed
- Conditions
- Healthy Volunteers
- Interventions
- Registration Number
- NCT01725009
- Lead Sponsor
- UCB Japan Co. Ltd.
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 32
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Levetiracetam IV infusions in Caucasian Multiple 15-minute intravenous infusions of 1500 mg levetiracetam Multiple 15-minute intravenous infusions of 1500 mg levetiracetam in Caucasian subjects Levetiracetam IV infusions in Japanese Multiple 15-minute intravenous infusions of 1500 mg levetiracetam Multiple 15-minute intravenous infusions of 1500 mg levetiracetam in Japanese subjects
- Primary Outcome Measures
Name Time Method Area under the curve from zero to the time of the last quantifiable concentration after a single (AUC(0-t)) 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) 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) 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)) 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 after a single dose (Cmax) 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 over a dosing interval at steady state after multiple doses (AUCτss) 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. Maximum plasma concentration at steady state after multiple doses (Cmax,ss) 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 plasma concentration time curve from zero to infinity after a single dose, (AUC) 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 at steady state after multiple doses (Cmax,ss) 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) 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 Outcome Measures
Name Time Method Accumulation ratio (RAUC) after multiple doses 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
Terminal elimination half-life after a single dose (t1/2) 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) 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) 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) 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) 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) 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. Linearity factor after multiple doses (LF) 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
Area under the curve over a dosing interval, (AUCτ (τ = 12 hours)) 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 after a single dose (CL) 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) 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.
Trial Locations
- Locations (1)
01
🇯🇵Tokyo, Japan