Specific PET Radioligand Binding to Translocator Protein

Completed · Phase 1

Conditions studied: Baseline, Blocking Receptor Binding

In brief

Background: \- A brain protein called translocator protein (TSPO) shows changes in some brain diseases. A radioactive drug called 11C-(R)-PK 11195 is used to take pictures of TSPO using a camera called positron emission tomography (PET). Researchers want to find out how well 11C-(R)-PK 11195 takes the pictures. Objective: \- To evaluate the radioactive chemical 11C-(R)-PK 11195. Eligibility: \- Healthy volunteers ages 18-55. Design: * Participants will be screened with a medical exam. * Participants will have scans at up to 4 visits. * PET scan using 11C-(R)-PK 11195: * A small tube (catheter) will be put into an artery at the wrist or elbow, by a needle. The needle will be removed, leaving only the catheter in the artery. Blood samples will be taken through this catheter. * Another catheter will be placed into a vein in the arm or hand. * 11C-(R)-PK 11195 will be injected through the second catheter. * The PET scanner is shaped like a doughnut. Participants will lie on a bed that slides in and out of it. They may get a plastic mask for their face and head. * Participants will receive a dose of emapunil by mouth. Participants will then have another PET scan. * Participants may have a magnetic resonance imaging (MRI) scan. The MRI scanner is a metal cylinder surrounded by a magnetic field. The participant will lie on a table that can slide in and out of the cylinder. Participants will get earplugs for the loud knocking noises. * After each scan, participants will get a follow-up phone call. Two to seven days after taking emapunil, participants will return for a follow-up visit.

Key facts

Study ID

NCT02181582

Run by

National Institute of Mental Health (NIMH)

People needed

32

Starts

2014-06-24

Expected to finish

2016-11-23

Last updated by the study team

2018-09-27

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• Any past or present Axis I psychiatric disorder. Any history of alcohol or substance dependence, except nicotine dependence, within the past 6 months
• Serious medical problems including but not limited to chronic neurological disease such as multiple sclerosis, autoimmune diseases, or serious cardiopulmonary disease.
• Active seizure disorder, as defined as having had a seizure in the past year or being on antiepileptic medications for seizures.
• Positive HIV test.
• Recent research-related exposure to radiation (i.e., PET from other research) which when combined with this study would be above the allowable limits.
• Metallic foreign bodies that would be affected by the MRI magnet or fear of enclosed spaces likely to make the subject unable to undergo an MRI scan.
• Claustrophobia
• Positive urine drug screen at time of enrollment.
• Pregnancy at time of scan (beta-HCG will be measured in all female patients within 24 hours before start of scan and must be negative). Lactating women who are breast feeding.
• Prescription or over-the counter medication use; psychotropic herb use (e.g., St. John s Wort).
• Are not able to comfortably lie flat on the back for at least two and a half hours at a time

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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