Recruiting
Early Phase 1

\[18F\]GATT-44

Sponsor:

Yale University

Code:

NCT07457736

Conditions

Healthy Adult Participants

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

Interventions

[ 18F]GATT-44

Study Details

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.

Conditions

Healthy Adult Participants

Study ID

NCT07457736

Start date

Jan 28, 2026

Status verified date

Jan, 2026

Completion date

Jan, 2030

Anticipated

Primary completion date

Jan, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

32 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

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

Interventions

[ 18F]GATT-44

First in human radiotracer being evaluated in this study.

Primary outcome measure

  • Test-Retest reproducibility calculations [ Time Frame: PET Day 1 and PET Day 2 ]
  • Specific binding levels of [18F]GATT44 in humans. [ Time Frame: PET Day 1 and PET Day 2 ]
  • Whole body radiation dosimetry calculated from PET-CT images [ Time Frame: PET Scan Day 1 ]

Central Contacts and Locations

Locations

Yale University PET Center

Recruiting

New Haven, Connecticut, United States, 06519

Contacts

Principal Investigator:

Richard E Carson, PhD

More Information

Sponsor

Yale University

Last update posted

Aug 20, 2026

Last verified

Jan, 2026

Keywords

  • gatt44
  • experimental radiotracer
  • first in human radiotracer
  • GAT-1
  • GATT-44

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2026-08-20.