Healthy Volunteers
Conditions
Keywords
Healthy volunteers, Japanese, Caucasian
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
Interventions
DRUGMultiple 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
Sponsors
UCB Japan Co. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 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 |
| 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 |
| 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. |
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 |
| 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. | — |
| 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. | — |
| 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. | — |
| 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. | — |
| 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. | — |
| 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 |
Countries
Japan
Outcome results
None listed