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FNP-59 for High Cholesterol

Phase < 1

Recruiting

Led By Ben Viglianti, M.D, Ph.D.

Research Sponsored by Benjamin Viglianti

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Unable to do imaging

Known adrenal pathology

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 0

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a new imaging agent to see if it can help doctors better visualize the adrenal gland. This could lead to improved treatment of adrenal gland disorders.

Who is the study for?

This trial is for healthy individuals without any adrenal gland issues. They must not be pregnant, imprisoned, or unable to consent. Participants should not be on steroids, certain blood pressure medications (ACE inhibitors/ARBs), hormone treatments like oral contraceptives, or weigh over 400 lbs.

What is being tested?

[18F]FNP-59 is being tested as a new PET imaging agent that could potentially provide clearer images of the adrenal glands with less radiation exposure compared to current methods. This phase 0 study involves a single sub-therapeutic dose in normal subjects.

What are the potential side effects?

As this is an initial test of [18F]FNP-59 in humans primarily for imaging purposes and uses a sub-therapeutic dose, specific side effects are unknown but may include reactions at the injection site or allergic responses.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot undergo imaging tests.

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I have a diagnosed adrenal gland condition.

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I am currently taking steroids, birth control pills, hormone treatments, blood pressure medication, or hormone-like supplements.

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My body weight is over 400 lbs.

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I can give my own consent to participate.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 0

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 0

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Uptake for [18F]FNP-59 in the adrenal glands using the standardized uptake value (SUV) based on gland segmentation

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Group 1Experimental Treatment1 Intervention

These subjects, 6 planned (3 male, 3 female), will be to obtain normal tissue distribution of \[18F\]NP-59 and confirm calculated radiation dosimetry and optimal uptake time.

0 / 5Eligibility criteria met