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

Healthy Volunteers Clinical Trial

Official title:

A Single-center, Open-label, Multiple-dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Levetiracetam Administered as Intravenous Infusion in Japanese and Caucasian Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01725009
• Other study ID #: EP0038
• Status: Completed
• Phase: Phase 1
• First received: November 7, 2012
• Last updated: March 27, 2013
• Start date: October 2012
• Est. completion date: December 2012

Study information

• Verified date: March 2013
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 40 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Japan	01	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
UCB Japan Co. Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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.	No
Primary	Area under the curve over a dosing interval at steady state after multiple doses (AUCtss)		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.	No
Primary	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.	No
Primary	Body-weight normalized area under the curve over a dosing interval at steady state after multiple doses (AUCtss)		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.	No
Secondary	Area under the curve over a dosing interval, (AUCt (t = 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	No
Secondary	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.	No
Secondary	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.	No
Secondary	First order terminal elimination rate constant after a single dose (?z)		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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	Linearity factor after multiple doses (LF)	LF = AUCtss / 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 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.	No
Secondary	Accumulation ratio (RAUC) after multiple doses	RAUC = AUCtss / AUCt	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	No