Specific PET Radioligand Binding to Translocator Protein

• Status: Completed
• Trial end date: 2016-11-23
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Institute of Mental Health (NIMH)

Criteria

• INCLUSION CRITERIA:

1. Male or female subjects between 18 to 55 yrs of age and able to give written informed consent.

2. Subjects must be healthy based on medical history, physical examination and laboratory testing.

3. Be able to provide own consent.

4. Agree to use contraception for 30 days after emapunil administration.

EXCLUSION CRITERIA:

1. Any past or present Axis I psychiatric disorder. Any history of alcohol or substance dependence, except nicotine dependence, within the past 6 months

2. Serious medical problems including but not limited to chronic neurological disease such as multiple sclerosis, autoimmune diseases, or serious cardiopulmonary disease.

3. Active seizure disorder, as defined as having had a seizure in the past year or being on antiepileptic medications for seizures.

4. Positive HIV test.

5. Recent research-related exposure to radiation (i.e., PET from other research) which when combined with this study would be above the allowable limits.

6. 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.

7. Claustrophobia

8. Positive urine drug screen at time of enrollment.

9. 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.

10. Prescription or over-the counter medication use; psychotropic herb use (e.g., St. John s Wort).

11. Are not able to comfortably lie flat on the back for at least two and a half hours at a time