NCT04532489EARLY_PHASE1RecruitingAccepts Healthy Volunteers
Positron Emission Tomography (PET) Imaging of Cholesterol Trafficking: Clinical Evaluation of [18F]FNP-59 in Normal Human Subjects (Group 1)
Benjamin Viglianti
Start Date
1/18/2021
Completion Date
12/1/2026
Summary
This exploratory, first-in-man, phase 0 study will evaluate the feasibility of using a sub-therapeutic dose of a fluorine-18 analogue of NP-59 (\[18F\]FNP-59) to image the adrenal gland in healthy normal subjects. The researchers believe that \[18F\]FNP-59 would greatly improve the imaging characteristics, by providing a PET imaging cholesterol analogue with significantly improved radiation dosimetry.
Detailed Description
Following the results of radiation dosimetry from this study then next steps will be taken for groups 2 \& 3 using hormone manipulation.
Eligibility Criteria
Age Range: 18 years to No maximum
Inclusion Criteria:
* Participants without any known adrenal pathology as normal controls for radiation dosimetry purposes
Exclusion Criteria:
* Pregnancy
* Unable to do imaging
* Body weight greater than 400 lbs (181 Kg)
* Prisoners are not eligible
* Subjects unable to provide own consent are not eligible
* Current use of steroids, Oral contraceptives (OCP), spironolactone, estrogen, androgen, progesterone, Angiotensin-converting enzyme (ACE inhibitors)/ Angiotensin II receptor blockers (ARBs), or supplements that are hormone analogues.
* Known adrenal pathology
Interventions
DRUG
FNP-59
Conditions
RadiotracerHypertensionCholesterol
Locations
University of Michigan
Ann Arbor, Michigan 48109
United States