Ignite Creation Date:
2024-05-06 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06181760
Status:
COMPLETED
Last Update Posted:
2024-02-23
First Post:
2023-10-25
Brief Title:
A Study to Evaluate the Safety of Fenretinide in Healthy Volunteers
Sponsor:
Island Pharmaceuticals
Organization:
Island Pharmaceuticals
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:
2024-02
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 is to learn about a single dose of fenretinide in healthy volunteers in both a fasted and fed state The main questions it aims to answer are 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 Researchers will compare active fenretinide to placebo to see if fenretinide is more or less tolerable than placebo
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 Researchers 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 will also be administered ISLA101 under fed conditions in a cross-over manner Cohort 4 Proposed doses are 300 600 and 900 mgm2 equivalent to 81 162 and 243 mgkg 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
The study will include a 5-day stay in the clinical research unit followed by a final safety follow-up visit at Day 8
Study Oversight
Has Oversight DMC:
None
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?:
None