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
NCT ID: NCT02602860
Last Updated: 2017-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
13 participants
INTERVENTIONAL
2015-11-30
2017-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
OTHER
NONE
Study Groups
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Levetiracetam
Cohort 1: Half of the subjects will receive LEV as a 5 minute iv infusion during the second Positron Emission Tomography (PET) scan, 60 minutes after the start of \[11C\]UCB-J administration.
Cohort 2: Half of the subjects will receive LEV as a 5 minute iv infusion during the first PET scan, 60 minutes after the start of \[11C\]UCB-J administration. The dose of LEV (500 mg to 2500 mg) or BRV (50 mg to 200 mg) will be decided based on the data obtained in Cohort 1. Subjects will return for a second PET imaging session (Visit 4), 7 to 28 days after completion of their first session (Visit 3) to enter the BRV arm.
[11C]UCB-J
* Pharmaceutical form: Sterile solution for intravenous infusion
* Concentration: 20 mCi
* Route of Administration: iv
Levetiracetam
* Pharmaceutical form: Sterile solution for intravenous infusion
* Concentration: 100 mg/ml
* Route of Administration: iv
Brivaracetam
Cohort 1:Half of the subjects will receive BRV as a 5 minute iv infusion during the second Positron Emission Tomography (PET) scan, 60 minutes after the start of \[11C\]UCB-J administration.
Cohort 2:Half of the subjects will receive BRV as a 5 minute iv infusion during the first PET scan, 60 minutes after the start of \[11C\]UCB-J administration. The dose of BRV (50-200 mg) will be decided based on the data obtained in Cohort 1. Subjects will return for a second PET imaging session,7 to 28 days after completion of their first session to enter the LEV arm.
Cohort 3:void Cohort 4:Subjects will take oral BRV (25-100 mg bid) for 4 days and a single dose of BRV on Day 5. Pre-/post-block scans will be obtained at the first dose, one post-block scan after the last dose. Additional post-block scans may be obtained 8-10 and 28h or later after last dose; if last scan not needed, subject will return 7 to 28 days later for a post-block scan. Dose range for LEV in Cohort 4 will be 250 to \<1500mg.
[11C]UCB-J
* Pharmaceutical form: Sterile solution for intravenous infusion
* Concentration: 20 mCi
* Route of Administration: iv
Brivaracetam
* Pharmaceutical form: Sterile solution for intravenous infusion
* Concentration: 10 mg/ml
* Route of Administration: iv
Brivaracetam
* Pharmaceutical form: Tablets for oral intake
* Concentration: 25 mg
* Route of Administration: oral
Interventions
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[11C]UCB-J
* Pharmaceutical form: Sterile solution for intravenous infusion
* Concentration: 20 mCi
* Route of Administration: iv
Brivaracetam
* Pharmaceutical form: Sterile solution for intravenous infusion
* Concentration: 10 mg/ml
* Route of Administration: iv
Levetiracetam
* Pharmaceutical form: Sterile solution for intravenous infusion
* Concentration: 100 mg/ml
* Route of Administration: iv
Brivaracetam
* Pharmaceutical form: Tablets for oral intake
* Concentration: 25 mg
* Route of Administration: oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
55 Years
ALL
Yes
Sponsors
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PRA Health Sciences
INDUSTRY
Yale University
OTHER
UCB Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Cares
Role: STUDY_DIRECTOR
+1-844-599-2273(UCB)
Locations
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Ep0074 001
New Haven, Connecticut, United States
Countries
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References
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Finnema SJ, Rossano S, Naganawa M, Henry S, Gao H, Pracitto R, Maguire RP, Mercier J, Kervyn S, Nicolas JM, Klitgaard H, DeBruyn S, Otoul C, Martin P, Muglia P, Matuskey D, Nabulsi NB, Huang Y, Kaminski RM, Hannestad J, Stockis A, Carson RE. A single-center, open-label positron emission tomography study to evaluate brivaracetam and levetiracetam synaptic vesicle glycoprotein 2A binding in healthy volunteers. Epilepsia. 2019 May;60(5):958-967. doi: 10.1111/epi.14701. Epub 2019 Mar 29.
Other Identifiers
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EP0074
Identifier Type: -
Identifier Source: org_study_id