Assessment of [11C]ER176 to Image Translocator Protein in Brain and Whole Body of Healthy People

Completed · Early Phase 1

Conditions studied: Pharmacokinetics, Adult

In brief

Background: \- A protein called translocator protein may play a role in brain inflammation. Sometimes it is present at higher levels in the lungs than in the brain. Researchers want to see if a drug called \[11C\]ER176 can provide an image of this protein in the brain. Objective: \- To test the ability of a drug to image a protein, and test how it is distributed in the body. Eligibility: \- Healthy adults over age 18. Design: * Participants will be screened with medical history, physical exam, and blood and urine tests. * Participants will have a PET scan of the brain using \[11C\]ER176. It will be injected through an intravenous tube into 1-2 arm veins. A tube may also be put into an artery at the wrist or elbow. Some participants will also have a lung scan. * For the PET, participants will lie on a bed that slides in and out of a doughnut-shaped scanner. A plastic mask will be molded to their face and head. They may be wrapped with restraining sheets. The scan will last about 120 minutes. Blood may be taken during the scan. * Blood and urine will be taken before and after the scan. * During another visit, participants will have an MRI scan of the brain. Participants will lie on a table that slides in and out of a metal cylinder. A strong magnetic field and radio waves will take pictures of the brain. The scanner makes loud knocking noises. Participants will be given earplugs. * Some participants will have only a whole-body PET scan using \[11C\]ER176.

Key facts

Study ID

NCT02147392

Run by

National Institute of Mental Health (NIMH)

People needed

16

Starts

2014-05-14

Expected to finish

2016-06-16

Last updated by the study team

2018-07-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• Any current Axis I diagnosis.
• Clinically significant laboratory abnormalities.
• Positive test for HIV.
• Unable to have a MRI scan.
• History of neurologic illness or injury with the potential to affect study data interpretation.
• History of seizures, other than in childhood and related to fever.
• Recent exposure to radiation (i.e., PET from other research) which when combined with this study would be above the allowable limits.
• Inability to lie flat on camera bed for at least two hours.
• Pregnancy or breast feeding.
• Drug/alcohol abuse or dependence
• Current use of prescription or chronic (more than 3 continuous weeks) use of over-the-counter medications for pain, fever or other inflammation including prednisolone (Orapred), aspirin (Ecotrin), ibuprofen (Advil), and acetaminophen (Tylenol). The medications will be reviewed to see if subject can be in the study. If the subject is taking any medication that is not permitted, he/she may be in the study if the medication can be safely stopped for three weeks. The subject s primary care doctor will be contacted to stop a medication if necessary. A written permission will be obtained from the subject to contact his/her doctor.
• Please note that exclusion criteria for the dosimetry subjects are the same reported above, except for MRI contraindications, because an MRI will not be performed in these subjects.

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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