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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02602860
• Date of registration: 06/11/2015
• Prospective Registration: No
• Primary sponsor: UCB Pharma
• Public title: 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
• Scientific 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
• Date of first enrolment: November 2015
• Target sample size: 13
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02602860
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: UCB Cares
• Affiliation: [phone](UCB)

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Healthy Volunteers

Intervention(s)

Drug: Levetiracetam

Drug: Brivaracetam

Radiation: [11C]UCB-J

Primary Outcome(s)

Level of synaptic vesicle glycoprotein 2A (SV2A) receptor occupancy during the displacement scans [Time Frame: Displacement scans (120 minutes)]

Tracer-exit corrected halftimes of Brivaracetam or Levetiracetam entry [Time Frame: Baseline (120 minutes) and Displacement scans (120 minutes)]

Tracer displacement halftimes [Time Frame: Baseline (120 minutes) and Displacement scans (120 minutes)]

Equilibrium tissue to plasma activity ratio (VT) of [11C]UCB-J [Time Frame: Baseline (120 minutes) and Displacement scans (120 minutes)]

Secondary ID(s)

EP0074

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

PRA Health Sciences

Yale University