MedDataX Logo

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

NCT ID: NCT01725009

Last Updated: 2013-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2012-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Volunteers

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Healthy volunteers Japanese Caucasian

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Levetiracetam IV infusions in Japanese

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

Group Type EXPERIMENTAL

Multiple 15-minute intravenous infusions of 1500 mg levetiracetam

Intervention Type DRUG

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

Levetiracetam IV infusions in Caucasian

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

Group Type EXPERIMENTAL

Multiple 15-minute intravenous infusions of 1500 mg levetiracetam

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Multiple 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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

E-Keppra

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

UCB Japan Co. Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

01

Tokyo, , Japan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Japan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EP0038

Identifier Type: -

Identifier Source: org_study_id