Recruiting
Phase 1

18F-TPP

Sponsor:

Yale University

Code:

NCT07506616

Conditions

Membrane Potential Mapping

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Accepted

Interventions

18F-TPP

Study Details

Brief summary:

In this study, investigators propose to use PET imaging to study the pharmacokinetics of 18F-TPP and develop methods for imaging membrane potential (ΔΨT) in humans.

Conditions

Membrane Potential Mapping

Study ID

NCT07506616

Start date

Aug, 2026

Status verified date

Sep, 2025

Completion date

Aug, 2033

Anticipated

Primary completion date

Aug, 2033

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Willing and able to give voluntary written informed consent
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • In good general health as evidenced by medical history, physical examination, ECG, serum/urine biochemistry and hematology tests.
  • If female of childbearing potential, must agree to use an acceptable method of birth control, as determined by the principal investigator, for the duration of the study.

Exclusion Criteria:

  • Know structural heart disease (e.g. myocardial infarction)
  • Abnormal and clinically significant ECG (as determined by the Investigator or his/her designee) at screening.
  • Laboratory tests with clinically significant abnormalities at screening
  • Pregnancy or Lactation
  • MRI incompatible implants (i.e., such as pacemaker, artificial joints, non-removable body piercings) and other contraindications for MRI, such as claustrophobia, having implanted or embedded metal objects/fragments or fragments in the head or body that would present a risk during the MRI scanning procedure, or have worked with ferrous metals either as a vocation or hobby (for example, as a sheet metal worker, welder, or machinist).
  • Participation in other research studies involving ionizing radiation within one year of the PET scans that would cause the subject to exceed the yearly dose limits followed by the Yale University PET Center.
  • Subject who has current, past, or anticipated exposure to radiation in the workplace within one year of the proposed research scans that in combination with the study tracer would result in a cumulative exposure that exceeds recommended exposure limits.
  • Has any condition that, in the opinion of the investigator, would prevent compliance with the study protocol.
  • Arterial Line Exclusion: Blood donation within eight weeks of the start of the study.
  • Arterial Line Exclusion: History of a bleeding disorder or are currently taking anticoagulants (such as Coumadin, Heparin, Pradaxa, Xarelto).
  • Arterial Line Exclusion: Prothrombin Time (PT) and Partial Thromboplastin Time (PTT) greater than 5msec above the upper limit of normal.
  • Arterial Line Exclusion: Unable to safely discontinue or hold aspirin and other NSAID use

Study Design

Enrollment

24 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: 18F-TPP

PET imaging to study the pharmacokinetics of 18F-TPP and develop methods for imaging membrane potential (ΔΨT) in humans. Each scan may or may not have arterial blood sampling for measurement of the time course of radioactivity in the whole-blood, plasma and radiometabolite analysis on selected plasma samples.

Interventions

18F-TPP

radiotracer specific for imaging mitochondrial membrane potential (ΔΨm) administered intravenously

Primary outcome measure

  • Tracers volume of distribution (VT) [ Time Frame: Visit 2 (up to 90 days post screening visit 1) ]

Central Contacts and Locations

Central contacts

Shannan Henry

(203) 737-5278shannan.henry@yale.edu

Kristen Torres, BS

203-785-4799kristen.torres@yale.edu

Locations

Yale University PET Center

Recruiting

New Haven, Connecticut, United States, 06510

More Information

Sponsor

Yale University

Last update posted

Aug 31, 2026

Last verified

Sep, 2025

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 2026-08-31.