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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
13
* Pharmaceutical form: Sterile solution for intravenous infusion * Concentration: 20 mCi * Route of Administration: iv
* Pharmaceutical form: Sterile solution for intravenous infusion * Concentration: 10 mg/ml * Route of Administration: iv
* Pharmaceutical form: Sterile solution for intravenous infusion * Concentration: 100 mg/ml * Route of Administration: iv
Ep0074 001
New Haven, Connecticut, United States
Level of synaptic vesicle glycoprotein 2A (SV2A) receptor occupancy during the displacement scans
The receptor occupancy will be determined using occupancy plots from the apparent volume of distribution, Vapp values.
Time frame: Displacement scans (120 minutes)
Equilibrium tissue to plasma activity ratio (VT) of [11C]UCB-J
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.
Time frame: Baseline (120 minutes) and Displacement scans (120 minutes)
Tracer displacement halftimes
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.
Time frame: Baseline (120 minutes) and Displacement scans (120 minutes)
Tracer-exit corrected halftimes of Brivaracetam or Levetiracetam entry
Tracer-exit corrected halftimes of Brivaracetam or Levetiracetam entry will be estimated by subtracting the tracer clearance halftime from the displacement halftime.
Time frame: Baseline (120 minutes) and Displacement scans (120 minutes)
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* Pharmaceutical form: Tablets for oral intake * Concentration: 25 mg * Route of Administration: oral