Evaluation of [18F]GATT-44 for Positron Emission Tomography Imaging of the GABA Transporter-1

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT07457736
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Healthy Adult Participants

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • [ 18F]GATT-44 — DRUG
    First in human radiotracer being evaluated in this study.

Study Details

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.

Key Dates

Start date
Apr 30, 2026
Status verified
Jan 2026
Primary completion
Jan 31, 2030
Completion
Jan 31, 2030

Study Design

Enrollment
32 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Healthy Control - Test/Retest
    In Part 1 we will conduct a test/retest study of the novel GABA Transporter (GAT-1) imaging tracer \[18F\]GATT44 in humans, to characterize its pharmacokinetic behavior and determine the reliability and reproducibility of in vivo pharmacokinetic parameter measurements
  • Experimental: Healthy Control - Test-Blocking
    In Part 2, we will conduct a test-blocking study to assess specific binding levels of \[18F\]GATT44 in humans.
  • Experimental: Healthy Control - Whole Body
    In Part 3, human dosimetry of \[18F\]GATT44 will be estimated by performing whole-body imaging studies

Primary Outcome Measure

Test-Retest reproducibility calculations [ Time Frame: PET Day 1 and PET Day 2 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Yale University PET CenterNew HavenConnecticut06519
Shannan Henry
[email protected]
+1 (203) 737-5278
Kayla R Cottiers
[email protected]
203-737-7496
Richard E Carson, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Yale University PET Center· New Haven, CT

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