Specific PET Radioligand Binding to Translocator Protein

NCT02181582 | Completed Phase 1

• 2 other identifiers: 14014114-M-0141
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Health Humans; Receptor Occupancy

Outcome Measures

Primary Outcomes (1)

• Signal noise ratio [C-11](R)-PK 11195

  2 moths

Study Arms (1)

Emapunil Administration

EXPERIMENTAL

Single Arm Study

Drug: Emapunil; Device: PET

Interventions

Emapunil DRUG

Single peroral administration

Emapunil Administration

PET DEVICE

Positron emission tomography, which creates images by detecting radioactivity.

Emapunil Administration

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female subjects between 18 to 55 yrs of age and able to give written informed consent.
• Subjects must be healthy based on medical history, physical examination and laboratory testing.
• Be able to provide own consent.
• Agree to use contraception for 30 days after emapunil administration.

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

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Study Officials

• Masahiro Fujita, M.D.

  National Institute of Mental Health (NIMH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2014
• First Posted: July 4, 2014
• Study Start: June 24, 2014
• Primary Completion: June 16, 2016
• Study Completion: November 23, 2016
• Last Updated: September 27, 2018

Record last verified: 2016-11-23

Locations

US (1)