A Study to Evaluate the Safety of Fenretinide in Healthy Volunteers
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.
Timeline
- Start
- 2023-11-22
- Primary completion
- 2024-02-13
- Completion
- 2024-02-13
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | fenretinide | Small molecule | 300 mg/m2 | Oral |
| Comparator | fenretinide | Small molecule | 600 mg/m2 | Oral |
| Comparator | fenretinide | Small molecule | 900 mg/m2 | Oral |
Indications
No indication recorded.