NCT07457736 Evaluation of [18F]GATT-44 for Positron Emission Tomography Imaging of the GABA Transporter-1
| NCT ID | NCT07457736 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Yale University |
| Condition | Healthy Adult Participants |
| Study Type | INTERVENTIONAL |
| Enrollment | 32 participants |
| Start Date | 2026-04 |
| Primary Completion | 2030-01 |
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 32 participants in total. It began in 2026-04 with a primary completion date of 2030-01.
⚠ 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
Evaluate \[18F\]GATT-44 (aka \[18F\]GAT44), to characterize its pharmacokinetic, metabolic, and in vivo binding profile, and assess the reproducibility of kinetic and binding parameters. Assess specific binding levels of \[18F\]GATT-44 by conducting a test-block study in humans. Estimate human dosimetry of \[18F\]GATT-44 by performing whole-body imaging studies.
Eligibility Criteria
Inclusion Criteria: 1. Willing and able to give voluntary written informed consent; 2. Able to read and write, able to communicate effectively with the investigator, and comply with all study requirements, restrictions, and directions of the research staff; 3. Male or female, aged 18 to 60, at screening; 4. In good general health as evidenced by medical history, physical examination, ECG, serum/urine biochemistry, hematology, and serology tests; 5. Females of childbearing potential, and male subjects, must be willing to practice birth control for the duration of the study (unless medical documentation is provided confirming subject is permanently sterile). Exclusion: 1. Less than 18 years of age; 2. Pregnant or breastfeeding; 3. Any significant systemic illness or unstable medical condition; 4. Pre-existing medical conditions or claustrophobic reactions; 5. Research-related radiation exposure exceeds current PET Center guidelines; 6. History of a bleeding disorder or are currently taking anticoagulants.
Contact & Investigator
Richard E Carson, PhD
PRINCIPAL INVESTIGATOR
Yale University
Frequently Asked Questions
Who can join the NCT07457736 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Healthy Adult Participants. 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 NCT07457736 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 NCT07457736 currently recruiting?
Yes, NCT07457736 is actively recruiting participants. Contact the research team at shannan.henry@yale.edu for enrollment information.
Where is the NCT07457736 trial being conducted?
This trial is being conducted at New Haven, United States.
Who is sponsoring the NCT07457736 clinical trial?
NCT07457736 is sponsored by Yale University. The principal investigator is Richard E Carson, PhD at Yale University. The trial plans to enroll 32 participants.