Safety Study of Fenretinide in Adult Patients With Cystic Fibrosis

PHASE1CompletedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

April 30, 2014

Primary Completion Date

February 28, 2015

Study Completion Date

February 28, 2015

Conditions
Cystic Fibrosis
Interventions
DRUG

Fenretinide

Fenretinide oral capsules of 100mg, each selected dose being administered once daily for 21 days (treatment cycle). Up to three total daily dose levels will be assessed in the study, as follows: 100mg of Fenretinide (one capsule) for the first treatment cycle, 200mg of Fenretinide (two capsules) in the second treatment cycle, and 300mg or 400mg of Fenretinide (3 or 4 capsules) will be selected for the third treatment cycle, based on safety and PK data collected.

DRUG

Placebo

A matching placebo will be used to keep the study double-blind.

Trial Locations (1)

H2X 2P4

Montreal Chest Institute, Montreal

All Listed Sponsors
lead

Elias Matouk

OTHER

NCT02141958 - Safety Study of Fenretinide in Adult Patients With Cystic Fibrosis | Biotech Hunter | Biotech Hunter