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

NCT01618877 | Completed Phase 1

• 1 other identifier: N01362B
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Volunteers

Keywords

Keppra Levetiracetam intravenous; Multiple dose; Safety; Pharmacokinetics; Chinese healthy volunteers

Outcome Measures

Primary Outcomes (2)

• Area under the plasma drug concentration-time curve over a dosing interval (AUCτ)

  The AUCτ is the area under the plasma concentration, after the last intravenous (iv) dose, versus time curve observed during the dosing interval τ.

  Pharmacokinetic samples were taken 36 hours after iv administration on Day 7

• Maximum measured plasma concentration (Cmax)

  The value of the maximum plasma concentration is directly obtained from the observed plasma concentration versus time curves.

  Pharmacokinetic samples were taken 36 hours after iv administration on Day 7

Secondary Outcomes (3)

• 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

• 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

Study Arms (2)

Levetiracetam iv infusion

EXPERIMENTAL

Levetiracetam intravenous (iv) infusion.

Drug: Levetiracetam

Placebo infusion

PLACEBO COMPARATOR

Other: Placebo

Interventions

Levetiracetam DRUG

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).

Also known as: Keppra

Levetiracetam iv infusion

Placebo OTHER

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).

Placebo infusion

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UCB Pharma: lead

Study Sites (1)

1

Shanghai, China

Location

Related Links

• FDA Safety Alerts and Recalls

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 Officials

• UCB Clinical Trial Call Center

  +1 877 822 9493 (UCB)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2012
• First Posted: June 13, 2012
• Study Start: May 1, 2012
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: August 3, 2012

Record last verified: 2012-08

Locations

CN (1)