NCT07625345 Evaluation of [11C]ZTP-1 to Image PDE4B
| NCT ID | NCT07625345 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | National Institute of Mental Health (NIMH) |
| Condition | Healthy |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2026-07-01 |
| Primary Completion | 2029-03-19 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 40 participants in total. It began in 2026-07-01 with a primary completion date of 2029-03-19.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Background: PDE4B is a protein in cells that helps turn off certain chemical signals after they ve done their job. It controls inflammation, immune responses, and some brain signaling. Measuring PDE4B levels in the body can help doctors manage a disease or know if a treatment is working. Researchers want to find out if a new tracer (a radioactive substance injected during imaging scans) can help them measure PDE4B in people more effectively. Objective: To test a new tracer (\[11C\]ZTP-1) during imaging scans of the brain and body in healthy people. Eligibility: Healthy people aged 18 and older. They must have been screened under protocols 01M-0254 or 17M0181. Design: Participants will have either 1 or 2 clinic visits. During their first visit, all participants will have a positron emission tomography (PET)/computed tomography (CT) scan. Prior to the scan, they will have blood and urine tests and a test of their heart function. The study tracer will be given through a tube attached to a needle inserted into a vein in the arm. They will lie on a padded bed that fits inside a doughnut-shaped machine; the machine uses x-rays to create images of the inside of the body. Some participants will have a PET/CT scan of their whole body. They will need only 1 visit. The visit will last up to about 8 hours. Some participants will have a PET/CT scan of only their brain. They will also have a magnetic resonance imaging (MRI) scan of the brain. They may need to return for a second visit for the MRI scan. Participants will receive a follow-up call to check on their well-being after their PET/CT scans.
Eligibility Criteria
* INCLUSION CRITERIA: To be eligible to participate in this study, an individual must meet the following criteria: * Aged 18 years or older. * Must have undergone a screening assessment under protocol 01M-0254, "The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Participants or protocol 17M0181 Recruitment and Characterization of Healthy Research Volunteers for NIMH Intramural Studies." * Be healthy based on medical history, physical examination, and laboratory testing. * Able to provide informed consent. * Willingness to complete all study procedures including MRI tests. * Have had their radial artery pulse checked for the presence of adequate ulnar collateral flow and the absence of any metal or foreign objects in both wrists. * Agree to adhere to the lifestyle considerations EXCLUSION CRITERIA: An individual who meets any of the following criteria will be excluded from participation in this study: * Clinically significant abnormalities on EKG or laboratory testing. This includes CBC and acute care panel (Na, K, Cl, CO2, creatinine, glucose, urea nitrogen). * History of neurologic illness or injury with the potential to affect study data interpretation. * History of seizures, other than in childhood and related to fever. * Recent exposure to radiation (i.e., PET from other research) that, when combined with this study, would be above the allowable limits. * Inability to lie flat on camera bed for at least two hours, including claustrophobia and weight greater than the maximum for the scanner (500 lbs). * HIV infection. * Pregnancy or breastfeeding. * Must not have substance use disorder or alcohol use disorder. * Unable to travel to the NIH. * Unable to have an MRI scan (e.g., because of pacemakers or other implanted electrical devices, brain stimulators, dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pumps, shrapnel fragments, or metal fragments in the eye. * Known hypersensitivity to phosphodiesterase-4 (PDE-4) inhibitors (e.g. apremilast, roflumilast, nerandomilast, crisborole). * Taking CYP3A4 inhibitors (e.g. grapefruit juice, clarithromycin, erythromycin, ritonavir); CYP3A4 inducers (e.g. phenobarbital St. John's Wort, rifampicin) or oral contraceptives containing gestodene and ethinyl estradiol. EXCLUSION OF CHILDREN: Inclusion of children is not appropriate, because this protocol has more than minimal risk from radiation exposure without the possibility of direct benefit. EXCLUSION OF PREGNANT OR BREASTFEEDING WOMEN: Pregnant women will be excluded because this protocol involves exposure to ionizing radiation. Lactating women will be excluded because radioisotopes may be excreted in milk. We will perform a pregnancy test at screening and prior to all procedures to ensure participants are not pregnant. The test must be negative in order to continue on the study. In addition to completing a negative urine pregnancy test, on the day of PET scanning prior to PET scan procedures, participants of childbearing potential will undergo a clinical pregnancy screening interview with a licensed independent practitioner to confirm lack of pregnancy. EXCLUSION OF PARTICIPANTS WHO ARE HIV POSITIVE: Persons with HIV infection are excluded because HIV infection itself may change cAMP signaling.
Contact & Investigator
Robert B Innis, M.D.
PRINCIPAL INVESTIGATOR
National Institute of Mental Health (NIMH)
Frequently Asked Questions
Who can join the NCT07625345 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 101 Years, studying Healthy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07625345 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07625345 currently recruiting?
Yes, NCT07625345 is actively recruiting participants. Contact the research team at tara.turon@nih.gov for enrollment information.
Where is the NCT07625345 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT07625345 clinical trial?
NCT07625345 is sponsored by National Institute of Mental Health (NIMH). The principal investigator is Robert B Innis, M.D. at National Institute of Mental Health (NIMH). The trial plans to enroll 40 participants.