[18F]GATT-44 for Imaging

Overseen By Kayla R Cottiers

Age: 18 - 65

Sex: Any

Trial Phase: Phase < 1

Sponsor: Yale University

Must not be taking: Anticoagulants

Disqualifiers: Pregnant, Breastfeeding, Bleeding disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

32 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Richard E Carson, PhD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

Inclusion Criteria

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

I am in good overall health based on recent medical tests.

I am willing to use birth control during the study.

Exclusion Criteria

Pregnant or breastfeeding

I am younger than 18 years old.

I have a history of bleeding problems or I am currently taking blood thinners.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Test/Retest

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

2 days

2 visits (in-person)

Test-Blocking

Conduct a test-blocking study to assess specific binding levels of [18F]GATT44 in humans

1 day

1 visit (in-person)

Whole Body Imaging

Estimate human dosimetry of [18F]GATT44 by performing whole-body imaging studies

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• [18F]GATT-44

How Is the Trial Designed?

Group I: Healthy Control - Whole Body Experimental Treatment 1 Intervention

In Part 3, human dosimetry of \[18F\]GATT44 will be estimated by performing whole-body imaging studies

Group II: Healthy Control - Test/Retest Experimental Treatment 1 Intervention

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

Group III: Healthy Control - Test-Blocking Experimental Treatment 1 Intervention

In Part 2, we will conduct a test-blocking study to assess specific binding levels of \[18F\]GATT44 in humans.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+