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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

NCT02602860 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2017-10-30

No results posted yet for this study

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

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

Sponsors & Collaborators

  • PRA Health Sciences

    collaborator INDUSTRY

  • Yale University

    collaborator OTHER

  • UCB Pharma

    lead INDUSTRY

Principal Investigators

  • UCB Cares · +1-844-599-2273(UCB)

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2017-09-30
Completion
2017-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02602860 on ClinicalTrials.gov