NCT06181760

A Study to Evaluate the Safety of Fenretinide in Healthy Volunteers

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 in Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Island Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial was to learn about a single dose of fenretinide in healthy volunteers, in both a fasted and fed state. The main questions to answer were: * 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 (fasted cohorts). * Consume a high fat meal prior to administration of study drug (fed cohort). * Return to the clinic for a single follow-up visit for safety assessments. The study will compare active fenretinide to placebo to see if fenretinide is more or less tolerable than placebo.

Detailed description

This study is a randomized, double-blind, placebo-controlled single ascending dose study. There are 3 planned dose-level cohorts (Cohorts 1-3). Each dose-level cohort will consist of 8 subjects (6 active + 2 placebo), who will be treated under fasted conditions. The subjects in the highest tolerated dose-level cohort (determined by the Safety Review Committee) will also be administered ISLA101 or placebo under fed conditions, in a cross-over manner (Cohort 4). Proposed doses are 300, 600, and 900 mg/m\^2 (equivalent to 8.1, 16.2, and 24.3 mg/kg). Each subject will be allocated to 1 dose level only. The study will include a 5-day stay in the clinical research unit followed by a final safety follow-up visit at Day 8, where subjects will be under fasted conditions when they are dosed on Study Day 1. For cohort 4, the study will again include a 5-day stay in the clinical research unit followed by a final safety follow-up visit at Day 17, where subjects will be under fed conditions when they are dosed on Study Day 10.

Conditions

• Safety and Tolerability

Interventions

Type	Name	Description
DRUG	Fenretinide	Ascending single doses of oral fenretinide
DRUG	Placebo	Single oral dose of matching placebo capsules

Timeline

• Start date: 2023-11-22
• Primary completion: 2024-02-13
• Completion: 2024-02-13
• First posted: 2023-12-26
• Last updated: 2025-01-27
• Results posted: 2025-01-27

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated drug study