A Randomized, Double-blind, Pharmacokinetics Study to Assess Safety, Tolerability of Levetiracetam 45 Minutes Intravenous Infusion During 4 Days of Bid Dosing in Chinese Healthy Volunteers

Sponsor

UCB Pharma (Industry)

Overall Status

Completed

CT.gov ID

NCT01618877

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The part B of N01362 is to assess the pharmacokinetic profile of Levetiracetam 1500 mg intravenous (iv) infusion during repeated dosing in Chinese healthy volunteers.

Condition or Disease	Intervention/Treatment	Phase
Human Volunteers	Drug: Levetiracetam Other: Placebo	Phase 1

Detailed Description

The study includes 2 parts, part A is to evaluate the bioequivalence of Levetiracetam (LEV) 1500 mg intravenous (iv) infusion when compared to oral tablet, part B is to assess the pharmacokinetic profile of LEV infusion during repeated dosing in Chinese healthy volunteers.

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Monocenter, Open-label, Two-way Randomized Cross-over Study to Evaluate the Bioequivalence of Levetiracetam Administered as a 45 Minutes Intravenous Infusion and Same Dosage Levetiracetam Oral Tablet (Part A); and a Randomized, Double-blind, Placebo-controlled, Parallel Study on the Safety, Tolerability and Pharmacokinetics of Levetiracetam 45 Minutes Intravenous Infusion During 4 Days of b.i.d. Dosing (Part B), in Chinese Healthy Volunteers

Study Start Date :

May 1, 2012

Actual Primary Completion Date :

Jul 1, 2012

Actual Study Completion Date :

Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Levetiracetam iv infusion Levetiracetam intravenous (iv) infusion.	Drug: Levetiracetam Levetiracetam 1.500 mg (500 mg/ 5 mL vials) administered as a 45 minutes intravenous infusion diluted in 100 mL 0.9 % saline solution every 12 hours from the morning of Day 3 (it is the first day in Part B) to the morning of Day 7 (it is the 5th day in Part B). Other Names: Keppra
Placebo Comparator: Placebo infusion	Other: Placebo 15 mL 0.9 % saline solution added to 100 mL 0.9 % saline solution, administered as a 45 minutes intravenous infusion every 12 hours from the morning of Day 3 ( it is the 1st day in Part B) to the morning of Day 7 (it is the 5th day in Part B).

Arm

Intervention/Treatment

Experimental: Levetiracetam iv infusion

Levetiracetam intravenous (iv) infusion.

Drug: Levetiracetam

Levetiracetam 1.500 mg (500 mg/ 5 mL vials) administered as a 45 minutes intravenous infusion diluted in 100 mL 0.9 % saline solution every 12 hours from the morning of Day 3 (it is the first day in Part B) to the morning of Day 7 (it is the 5th day in Part B).

Other Names:

Keppra

Placebo Comparator: Placebo infusion

Other: Placebo

15 mL 0.9 % saline solution added to 100 mL 0.9 % saline solution, administered as a 45 minutes intravenous infusion every 12 hours from the morning of Day 3 ( it is the 1st day in Part B) to the morning of Day 7 (it is the 5th day in Part B).

Outcome Measures

Primary Outcome Measures

Area under the plasma drug concentration-time curve over a dosing interval (AUCτ) [Pharmacokinetic samples were taken 36 hours after iv administration on Day 7]
The AUCτ is the area under the plasma concentration, after the last intravenous (iv) dose, versus time curve observed during the dosing interval τ.
Maximum measured plasma concentration (Cmax) [Pharmacokinetic samples were taken 36 hours after iv administration on Day 7]
The value of the maximum plasma concentration is directly obtained from the observed plasma concentration versus time curves.

Secondary Outcome Measures

Plasma concentration at the end of the 45-minutes intravenous (iv) infusion (C45'(iv)) [Pharmacokinetic samples were taken 36 hours after iv administration on Day 7]
The value of the plasma concentration at the end of the 45-min iv infusion is directly obtained from the experimental data of plasma concentration versus time curves.
Minimum plasma concentration over dosing interval after intravenous (iv) infusion (Cmin) [Pharmacokinetic samples were taken 36 hours after iv administration on Day 7]
Terminal half-life (t1/2) [Pharmacokinetic samples were taken 36 hours after iv administration on Day 7]
The terminal half-life associated with the terminal rate constant λ_z is calculated as: ln2/λ_z. λ_z is the first order rate constant of elimination.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Chinese, age 18-40, weight ≥ 50 kg
Healthy volunteers with normal vital signs, good physical and mental health status and normal electrocardiogram and laboratory test

Exclusion Criteria:

History or presence of each systems disorders capable of altering the absorption, metabolism or elimination of drugs, or of constituting a risk factor when taking the study medication
History or presence of drug addiction or excessive use of alcohol
Symptomatic or asymptomatic Orthostatic Hypotension at screening
Current smokers and former smokers
Heavy caffeine drinker
History of frequent and severe headache
Any drug treatment
Subjects who are known to have Serum Hepatitis or who are carriers of the Hepatitis B surface antigen, or Hepatitis C antibody or who are HIV positive
Subjects on a controlled sodium diet
Subject has made a blood donation or had a comparable blood loss