Healthy Volunteers
Conditions
Keywords
SV2A, Levetiracetam, Brivaracetam, PET
Brief 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.
Interventions
RADIATION[11C]UCB-J
* Pharmaceutical form: Sterile solution for intravenous infusion * Concentration: 20 mCi * Route of Administration: iv
DRUGBrivaracetam
* Pharmaceutical form: Sterile solution for intravenous infusion * Concentration: 10 mg/ml * Route of Administration: iv
DRUGLevetiracetam
* Pharmaceutical form: Sterile solution for intravenous infusion * Concentration: 100 mg/ml * Route of Administration: iv
Sponsors
PRA Health Sciences
Yale University
UCB Pharma
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Level of synaptic vesicle glycoprotein 2A (SV2A) receptor occupancy during the displacement scans | Displacement scans (120 minutes) | The receptor occupancy will be determined using occupancy plots from the apparent volume of distribution, Vapp values. |
| Equilibrium tissue to plasma activity ratio (VT) of [11C]UCB-J | 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. |
| Tracer displacement halftimes | 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. |
| Tracer-exit corrected halftimes of Brivaracetam or Levetiracetam entry | 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. |
Countries
United States
Outcome results
None listed