NCT02602860

A Brain Imaging Study With Positron Emission Tomography and the Radiotracer [11C]UCB-J to Estimate How Fast Brivaracetam and Levetiracetam Enter the Brain in Healthy Volunteers

A Single-center, Open-label Positron Emission Tomography Study to Evaluate the Time-course of Displacement of [11C]UCB-J by Brivaracetam and Levetiracetam in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: UCB Pharma · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study will estimate how fast two antiepileptic drugs (Levetiracetam and Brivaracetam) enter the human brain. Brain imaging will be used to measure how quickly the radioactive probe \[11C\]UCB-J exits the brain when Levetiracetam or Brivaracetam are given. This will be used to estimate how fast the antiepileptic drugs enter the brain.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
RADIATION	[11C]UCB-J	* Pharmaceutical form: Sterile solution for intravenous infusion * Concentration: 20 mCi * Route of Administration: iv
DRUG	Brivaracetam	* Pharmaceutical form: Sterile solution for intravenous infusion * Concentration: 10 mg/ml * Route of Administration: iv
DRUG	Levetiracetam	* Pharmaceutical form: Sterile solution for intravenous infusion * Concentration: 100 mg/ml * Route of Administration: iv
DRUG	Brivaracetam	* Pharmaceutical form: Tablets for oral intake * Concentration: 25 mg * Route of Administration: oral

Timeline

• Start date: 2015-11-01
• Primary completion: 2017-09-01
• Completion: 2017-09-01
• First posted: 2015-11-11
• Last updated: 2017-10-30

Locations

1 site across 1 country: United States