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

UCB

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Multiple 15-minute intravenous infusions of 1500 mg levetiracetam

Study type: Interventional

Funder types: Industry

Identifiers

NCT01725009

EP0038

Details and patient eligibility

About

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

Enrollment: 32 patients

Sex: Male

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

32 participants in 2 patient groups

Levetiracetam IV infusions in Japanese

Experimental group

Description:

Multiple 15-minute intravenous infusions of 1500 mg levetiracetam in Japanese subjects

Treatment:

Drug: Multiple 15-minute intravenous infusions of 1500 mg levetiracetam

Levetiracetam IV infusions in Caucasian

Experimental group

Description:

Multiple 15-minute intravenous infusions of 1500 mg levetiracetam in Caucasian subjects

Treatment:

Drug: Multiple 15-minute intravenous infusions of 1500 mg levetiracetam