NCT04532489

Positron Emission Tomography (PET) Imaging of Cholesterol Trafficking: Clinical Evaluation of [18F]FNP-59 in Normal Human Subjects (Group 1)

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: Benjamin Viglianti · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Radiotracer
• Hypertension
• Cholesterol

Interventions

Type	Name	Description
DRUG	FNP-59	FNP-59, a radiotracer, is administered for PET/CT scans.

Timeline

• Start date: 2021-01-18
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2020-08-31
• Last updated: 2025-12-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study