Title: Evaluation of a Novel PET Radioligand for Phosphodiesterase-4D (PDE4D)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03861000|
Recruitment Status : Recruiting
First Posted : March 4, 2019
Last Update Posted : May 27, 2019
The brain enzyme phosphodiesterase-4D (PDE4D) may affect thinking and depression. Drugs with some radioactivity can attach to enzymes and be seen on a scan. Researchers want to test a new radioactive drug, 11C-T-1650, to measure PDE4D in the brain and body. They also want to see if the new drug BPN14770 blocks 11C-T-1650 from the brain. They want to learn more about psychiatric disorders and possible treatments.
To study how well 11C-T-1650 helps show PDE4D on a scan and to see if BPN14770 blocks it.
Healthy adults at least 18 years old
Participants will be screened in other protocols.
Some participants will have 1 body PET scan.
Some participants will have 2 brain PET scans and 1 brain MRI within 1 year.
Some participants (ages 18 55) will:
Have 3 brain PET scans and 1 MRI
Take BPN14770 by mouth twice daily for 3 7 days
Have blood and urine tests
Have a follow-up physical exam and heart test
PET (positron emission tomography) scans will take 2 3 hours. Participants will:
Have a thin plastic tube (catheter) placed in an arm vein by needle.
Get a small amount of 11C-T-1650 injected via catheter. Another catheter may be placed to draw blood.
Lie quietly on a bed that slides into a donut-shaped scanner without sleeping. They may get a short break.
Have heart and vital signs monitored.
Have blood and urine tests.
Learn about drinking fluids and urinating after the scan
MRI (magnetic resonance imagining) scans will take 30 60 minutes:
Participants will lie on a table that slides into a metal cylinder in a magnetic field.
Sponsoring Institute: National Institute of Mental Health
|Condition or disease||Intervention/treatment||Phase|
|Depression||Drug: [C-11]T-1650 Drug: BPN14770||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of a Novel PET Radioligand for Phosphodiesterase-4D (PDE4D)|
|Actual Study Start Date :||March 12, 2019|
|Estimated Primary Completion Date :||March 11, 2022|
|Estimated Study Completion Date :||December 7, 2022|
- Binding of [C-11]T-1650 and binding site occupancy of BPN14770 [ Time Frame: 3 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03861000
|Contact: Holly Giesen||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||Robert B Innis, M.D.||National Institute of Mental Health (NIMH)|