drugset / Trial / NCT02181582

Specific PET Radioligand Binding to Translocator Protein

NCT02181582

Phase 1 Completed 32 enrolled National Institute of Mental Health (NIMH)
Non-randomizedSingle-groupOpen-labelDiagnostic

Summary

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.

Timeline

Start
2014-06-24
Primary completion
2016-06-16
Completion
2016-11-23

Drugs

EvaluationDrugModalityDoseRoute
Subject Emapunil Small molecule 15 mg Oral
Subject Emapunil Small molecule 90 mg Oral

Indications

No indication recorded.