(18F)FCWAY and the Blood-Brain Barrier

NCT01386476 | Completed

• 2 other identifiers: 11019511-M-0195
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Background: \- The blood-brain barrier helps protect the brain from infections and toxins in the blood stream. But it can also prevent certain drugs from reaching the brain to treat diseases or other problems. Researchers are interested in chemicals that will help show how the barrier works. One possible chemical, (18F)FCWAY, may be useful for studying the barrier. More tests are needed to determine how effective it is. Objectives: \- To test whether (18F)FCWAY can be used to help study the blood-brain barrier. Eligibility: \- Healthy volunteers between 18 and 50 years of age. Design:

• This study requires a screening visit and two scanning visits.
• Participants will be screened with a physical exam and medical history. They will also have blood and urine tests.
• At the first scanning visit, participants will have a magnetic resonance imaging scan to provide baseline images of the brain.
• Before the second visit, some participants will stay overnight in the hospital. They will receive the drug tariquidar, which may help the (18F)FCWAY show the blood-brain barrier more clearly.
• At the second scanning visit, all participants will have a positron emission tomography scan with (18F)FCWAY to see how well the drug shows the blood-brain barrier on the scan.

Conditions

Drug Resistance

Keywords

5-HT1A Receptors; Blood Brain Barrier; Drug Resistance; Healthy Volunteer; HV

Outcome Measures

Primary Outcomes (1)

• Tariquidar will increase uptake of 18F-FCWAY in brain

Secondary Outcomes (1)

• Tariquidar will delay brain peak of 18F-FCWAY

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects must be 18 to 50 years old.
• Subjects must be currently healthy, based on history, physical exam, and laboratory testing.
• With the exception of birth control pills, subjects must agree not to take any medication, prescription or over-the-counter, one week before and one week after receiving tariquidar.
• Subjects must be able and willing to give written informed consent.

You may not qualify if:

• Subjects routinely taking prescription medications, except birth control pills. That is, subjects should not discontinue mediations merely to participate in this study.
• Subjects taking recreational or over-the-counter drugs.
• Subjects will be excluded if they have any current Axis I diagnosis, including a current diagnosis of alcohol or substance abuse.
• History of psychotic symptoms or suicide attempt.
• Head trauma resulting in a period of unconsciousness lasting longer than 10 minutes or a history of seizures, because seizures may increase the function of P-gp.
• Recent exposure to radiation (i.e., PET from other research) which when combined with this study would be above the allowable limits.
• Pregnancy or breast feeding.
• Positive urine drug screen.
• Unlikely to tolerate small, enclosed spaces, as in the MRI.
• Metallic foreign bodies that would be affected by the MRI magnet or fear of enclosed spaces likely to make the subject unable to complete an MRI scan.
• Positive HIV status.
• Inability to lie flat on camera bed for about 2 (Omega) hours.

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

Related Publications (3)

• Kannan P, John C, Zoghbi SS, Halldin C, Gottesman MM, Innis RB, Hall MD. Imaging the function of P-glycoprotein with radiotracers: pharmacokinetics and in vivo applications. Clin Pharmacol Ther. 2009 Oct;86(4):368-77. doi: 10.1038/clpt.2009.138. Epub 2009 Jul 22.

  PMID: 19625998 BACKGROUND

• Zhang XY, Yasuno F, Zoghbi SS, Liow JS, Hong J, McCarron JA, Pike VW, Innis RB. Quantification of serotonin 5-HT1A receptors in humans with [11C](R)-(-)-RWAY: radiometabolite(s) likely confound brain measurements. Synapse. 2007 Jul;61(7):469-77. doi: 10.1002/syn.20392.

  PMID: 17415792 BACKGROUND

• Liow JS, Lu S, McCarron JA, Hong J, Musachio JL, Pike VW, Innis RB, Zoghbi SS. Effect of a P-glycoprotein inhibitor, Cyclosporin A, on the disposition in rodent brain and blood of the 5-HT1A receptor radioligand, [11C](R)-(-)-RWAY. Synapse. 2007 Feb;61(2):96-105. doi: 10.1002/syn.20348.

  PMID: 17117422 BACKGROUND

Study Officials

• Robert B Innis, M.D.

  National Institute of Mental Health (NIMH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: OTHER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2011
• First Posted: July 1, 2011
• Study Start: June 15, 2011
• Study Completion: September 1, 2016
• Last Updated: July 5, 2018

Record last verified: 2016-09-01

Locations

US (1)