NCT03649555

Brief Summary

The purpose of this study is to understand the reliability of \[18F\]-FTC-146 brain uptake in healthy controls.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 2019

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 28, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2021

Completed
Last Updated

September 10, 2025

Status Verified

September 1, 2025

Enrollment Period

1.1 years

First QC Date

August 25, 2018

Last Update Submit

September 9, 2025

Conditions

Healthy Controls

Outcome Measures

Primary Outcomes (1)

  • Reliability under test retest conditions

    Regional brain uptake of \[18F\]FTC-146 will be analyzed by kinetic modeling with metabolite-corrected arterial input functions to establish stability and reproducibility of \[18F\] FTC-146 VT in humans (n=6) under test and retest conditions.

    1 week

Study Arms (1)

[18F]-FTC-146

EXPERIMENTAL

\[18F\]-FTC-146

Drug: [18F]-FTC-146

Interventions

[18F]-FTC-146DRUG

Two 5 mCi \[18F\]-FTC-146 doses will be administered intravenously on two separate scan days at least one week apart (total per study = 10 mCi) Participants who complete both test days will receive 10 mCi total dose; however, if a participant is unable to return for a second test day due to unforeseen circumstances, they will receive 5 mCi total dose.

Also known as: Sigma-1 receptor radioligand
[18F]-FTC-146

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ages 18-65
  • either gender and all ethno-racial categories
  • capacity to provide informed consent
  • Female participants are expected to use an effective method of birth control throughout the study

You may not qualify if:

  • Any current or lifetime psychiatric diagnosis
  • Current or past use of psychotropic medication
  • Pregnant or nursing females
  • Major medical or neurological problem
  • Presence of metal in the body that is contraindicated for MRI scans

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychiatry and Behavioral Sciences

Stanford, California, 94304, United States

Location

Related Links

MeSH Terms

Interventions

6-(3-fluoropropyl)-3-(2-(azepan-1-yl)ethyl)benzo(d)thiazol-2(3H)-one

Study Officials

  • Carolyn Rodriguez, MD, PhD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 25, 2018

First Posted

August 28, 2018

Study Start

February 1, 2019

Primary Completion

March 3, 2020

Study Completion

March 3, 2021

Last Updated

September 10, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)