Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-26 @ 12:44 AM
Study NCT ID:
NCT06181760
Status:
COMPLETED
Last Update Posted:
2025-01-27
First Post:
2023-10-25
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Safety of Fenretinide in Healthy Volunteers
Sponsor:
Island Pharmaceuticals
Organization:
Study Overview
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 in Healthy Adult Volunteers
Status:
COMPLETED
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
* 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: