A Study of NST-6179 in Subjects With Intestinal Failure-Associated Liver Disease (IFALD).
Start Date
1/15/2024
Completion Date
6/30/2025
Summary
This is a phase 2a, multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of NST-6179 in subjects with intestinal failure-associated liver disease (IFALD) receiving parenteral nutrition (PN). The study will be conducted in 2 sequential parts. Up to 36 subjects diagnosed with IFALD will be enrolled in the study, of which up to 18 subjects will be enrolled in each of the 2 parts and randomized (2:1) to receive NST-6179 (N=12/part) or matched placebo (N=6/part). Subjects in Part A will receive once daily (QD) oral administration of 800 mg (32 mL solution) NST-6179 or placebo for 4 weeks. The NST-6179 dose for Part B is planned to be 1200 mg QD for 12 weeks. Actual dose, however, will be determined during the safety review meeting.
Eligibility Criteria
Age Range: 16 years to No maximum
Interventions
NST-6179 Part A
NST-6179 Part B
Matched Placebo
Conditions
Locations
Mayo Clinic Scottsdale Campus
Scottsdale, Arizona 85259
United States
University of California San Francisco Medical Center
San Francisco, California 94143
United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia 20007
United States
Emory University School of Medicine
Atlanta, Georgia 30322
United States
The University of Chicago Medical Center
Chicago, Illinois 60637
United States
Boston Children's Hospital
Boston, Massachusetts 02115
United States
Henry Ford Hospital
Detroit, Michigan 48202
United States
Mayo Clinic Rochester Campus
Rochester, Minnesota 55905
United States
Mount Sinai Medical Center
New York, New York 10029
United States
Duke University Medical Center
Durham, North Carolina 27710
United States
The Cleveland Clinic
Cleveland, Ohio 44195
United States
Vanderbilt University School of Medicine
Nashville, Tennessee 37232
United States
University of Washington
Seattle, Washington 98195
United States