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

Phase 1 Completed 13 enrolled UCB Pharma PRA Health Sciences · collab Yale University · collab

Non-randomizedSingle-groupOpen-labelOther

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.

Timeline

Start: 2015-11
Primary completion: 2017-09
Completion: 2017-09

Publications

Finnema SJ, Rossano S, Naganawa M, Henry S, Gao H, Pracitto R, Maguire RP, Mercier J, Kervyn S, Nicolas JM, Klitgaard H, DeBruyn S, Otoul C, Martin P, Muglia P, Matuskey D, Nabulsi NB, Huang Y, Kaminski RM, Hannestad J, Stockis A, Carson RE. A single-center, open-label positron emission tomography study to evaluate brivaracetam and levetiracetam synaptic vesicle glycoprotein 2A binding in healthy volunteers. Epilepsia. 2019 May;60(5):958-967. doi: 10.1111/epi.14701. Epub 2019 Mar 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Brivaracetam	Small molecule	25 mg	Intravenous
Subject	Brivaracetam	Small molecule	50 mg	Intravenous
Subject	Brivaracetam	Small molecule	100 mg	Intravenous
Subject	Brivaracetam	Small molecule	200 mg	Intravenous
Subject	Levetiracetam	Other / unclassified	250 mg	Intravenous
Subject	Levetiracetam	Other / unclassified	500 mg	Intravenous
Subject	Levetiracetam	Other / unclassified	600 mg	Intravenous
Subject	Levetiracetam	Other / unclassified	1500 mg	Intravenous
Subject	Levetiracetam	Other / unclassified	2500 mg	Intravenous

Indications

No indication recorded.