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A Study to Evaluate the Safety of Fenretinide in Healthy Volunteers

NCT06181760 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-01-27

Study results available
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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.

Conditions

  • Safety and Tolerability

Interventions

DRUG

Fenretinide

Ascending single doses of oral fenretinide

DRUG

Placebo

Single oral dose of matching placebo capsules

Sponsors & Collaborators

  • Beyond Drug Development

    collaborator UNKNOWN

  • Island Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Christopher Argent, MD · Scientia Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-22
Primary Completion
2024-02-13
Completion
2024-02-13
FDA Drug
Yes

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06181760 on ClinicalTrials.gov