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

NCT01725009 | Completed Phase 1

• 1 other identifier: EP0038
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy Volunteers

Keywords

Healthy volunteers; Japanese; Caucasian

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (11)

• 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

• 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.

Study Arms (2)

Levetiracetam IV infusions in Japanese

EXPERIMENTAL

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

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

Levetiracetam IV infusions in Caucasian

EXPERIMENTAL

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

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

Interventions

Multiple 15-minute intravenous infusions of 1500 mg levetiracetam DRUG

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

Also known as: E-Keppra

Levetiracetam IV infusions in Caucasian; Levetiracetam IV infusions in Japanese

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UCB Japan Co. Ltd.: lead

Study Sites (1)

01

Tokyo, Japan

Location

MeSH Terms

Interventions

Levetiracetam

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2012
• First Posted: November 12, 2012
• Study Start: October 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: March 29, 2013

Record last verified: 2013-03

Locations

JP (1)