At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating Fenretinide and Placebo for Safety and Tolerability. Completed, enrolled 25 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Ascending single doses of oral fenretinide
Single oral dose of matching placebo capsules