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Completed

NCT Number: 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

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Ep0074 001

New Haven, Connecticut, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Inclusion criteria

  • Subject is male or female and between 18 to 55 years of age (inclusive)
  • Subject is in good physical and mental health, in the opinion of the Investigator, determined on the basis of medical history, physical and neurological examinations, vital signs, 12-lead Electrocardiography (ECG), and clinical laboratory tests
  • Female subjects of childbearing potential must have a negative pregnancy test; female subjects of childbearing potential have to confirm that, for 1 month prior to the first administration of the study medication and during the entire study until the Safety Follow-Up (SFU) Visit she will either use a highly effective contraceptive method (eg, oral contraception, intrauterine device, diaphragm with spermicide) or abstain from sexual activity that can cause pregnancy

Exclusion criteria

Exclusion criteria

  • History or presence of clinically significant respiratory, gastrointestinal, renal, hepatic, pancreatic, hematological, cardiovascular, musculoskeletal, genitourinary, immunological, or dermatological disorders, or any type of cancer
  • Subject has a history of a neurological diagnosis, including but not limited to stroke, traumatic brain injury, epilepsy, space occupying lesions, multiple sclerosis, Parkinson's disease, vascular dementia, transient ischemic attack, or any other neurological disorder that may influence the outcome or analysis of the scan results
  • History of donation of more than 450 mL of blood within 60 days prior to dosing in the Yale PET center or planned donation before 30 days has elapsed since intake of study drug
  • The subject has Magnetic Resonance Imaging -incompatible (MRI - incompatible) implants and other contraindications for MRI, such as a pacemaker, artificial joints, non-removable body piercings, etc.
  • Subjects who have received a diagnostic or therapeutic radiopharmaceutical less than 7 days prior to participation in this study
  • Participation in other recent research studies < 1 month or < 1 year for studies involving ionizing radiation that would cause the subject to exceed the yearly dose limits for healthy volunteers

Treatment and study plan

[11C]UCB-J

Radiation
  • Pharmaceutical form: Sterile solution for intravenous infusion
  • Concentration: 20 mCi
  • Route of Administration: iv

Other names: [11C]APP311

Brivaracetam

Drug
  • Pharmaceutical form: Sterile solution for intravenous infusion
  • Concentration: 10 mg/ml
  • Route of Administration: iv

Other names: UCB34714

Levetiracetam

Drug
  • Pharmaceutical form: Sterile solution for intravenous infusion
  • Concentration: 100 mg/ml
  • Route of Administration: iv

Other names: Keppra, L059

Primary outcomes

  1. Level of synaptic vesicle glycoprotein 2A (SV2A) receptor occupancy during the displacement scans

    Time frame: Displacement scans (120 minutes)

    The receptor occupancy will be determined using occupancy plots from the apparent volume of distribution, Vapp values.

  2. Equilibrium tissue to plasma activity ratio (VT) of [11C]UCB-J

    Time frame: Baseline (120 minutes) and Displacement scans (120 minutes)

    The equilibrium tissue to plasma activity ratio (VT) will be used to quantify [11C]UCB-J binding in each brain region of interest before and after administration of Brivaracetam and Levetiracetam.

  3. Tracer displacement halftimes

    Time frame: Baseline (120 minutes) and Displacement scans (120 minutes)

    Tracer displacement halftimes will be estimated from Displacement scans and Baseline scans on the average standardized uptake value (SUV) for all regions over time during 60-minute timeframe.

  4. Tracer-exit corrected halftimes of Brivaracetam or Levetiracetam entry

    Time frame: Baseline (120 minutes) and Displacement scans (120 minutes)

    Tracer-exit corrected halftimes of Brivaracetam or Levetiracetam entry will be estimated by subtracting the tracer clearance halftime from the displacement halftime.

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Collaborators

  • PRA Health Sciences
  • Yale University

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Nov 11, 2015
Registry last updated
Oct 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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