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Specific PET Radioligand Binding to Translocator Protein

NCT02181582 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2018-09-27

No results posted yet for this study

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.

Conditions

  • Baseline
  • Blocking Receptor Binding

Interventions

DRUG

Emapunil

Single peroral administration

DEVICE

PET

Positron emission tomography, which creates images by detecting radioactivity.

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    lead NIH

Principal Investigators

  • Masahiro Fujita, M.D. · National Institute of Mental Health (NIMH)

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02181582 on ClinicalTrials.gov