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First received: October 25, 2023

Clinical Trial: A Study to Evaluate the Safety of Fenretinide in Healthy Volunteers

Study Status: Completed

Recruit Status: RECRUITING

Condition: Safety and Tolerability

Study Type: INTERVENTIONAL


Official Title: A Phase 1a, Randomized, Double-blind Placebo-controlled Study to Evaluate Safety and Tolerability and to Characterize the Pharmacokinetic Profile of Single Ascending Doses of Fenretinide Oral Capsules

Brief Summary: The goal of this clinical trial is to learn about a single dose of fenretinide in healthy volunteers, in both a fasted and fed state.The main questions it aims to answer are: •How well is a single dose of fenretinide tolerated?AND •How is a single dose of fenretinide metabolized in healthy volunteers?Participants will be asked to:Remain confined in a clinical research unit for 5 days after dosing.Provide blood samples for intense PK sampling and safety labs.Fast for 10 hours prior to administration of study drug…

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