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NCT03861000 · ClinicalTrials.gov registry record · Phase 1
Title: Evaluation of a Novel PET Radioligand for Phosphodiesterase-4D (PDE4D)
A Phase 1 study, sponsored by National Institute of Mental Health (NIMH).
- Completed
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
NCT03861000: Completed Phase 1 study, sponsored by National Institute of Mental Health (NIMH).
NCT03861000 is a Phase 1 study that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 3 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03861000, a Phase 1 study, has completed, sponsored by National Institute of Mental Health (NIMH).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
Background: 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. Objectives: To study how well 11C-T-1650 helps show PDE4D on a scan and to see if BPN14770 blocks it. Eligibility: Healthy adults at least 18 years old Design: 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 ...
Primary Outcome
To determine whether the uptake of 11C-T-1650 in brain reflects the distribution of PDE4D
Interventions
- DRUG BPN14770
- DRUG [C-11]T-1650
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2019-03-12 |
| Est. Completion | 2020-02-11 |
| Phase | Phase 1 |
What the finished NCT03861000 record still lists
NCT03861000 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which BPN14770 is the first listed.
NCT03861000 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03861000 about?
NCT03861000 is a clinical study titled "Title: Evaluation of a Novel PET Radioligand for Phosphodiesterase-4D (PDE4D)". Background: 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 ...
What is the current status of trial NCT03861000?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2019-03-12. Estimated completion is 2020-02-11.
What interventions are being tested in trial NCT03861000?
The interventions under investigation include: BPN14770 (DRUG), [C-11]T-1650 (DRUG).
Who is sponsoring clinical trial NCT03861000?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03861000's enrollment target sits among peer trials
3 1999th of 2000 higher than 1 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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