A Study of NST-6179 in Subjects With Intestinal Failure-Associated Liver Disease (IFALD).

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
NorthSea Therapeutics B.V.
Study ID
NCT05919680
Phase
PHASE2
Status
Recruiting
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Conditions

  • Intestinal Failure Associated Liver Disease

Eligibility Criteria

Sex
ALL
Age
16 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • NST-6179 Part A — DRUG
    Once daily (QD) oral administration of 800mg (32 mL solution) of NST-6179 for 4 weeks
  • NST-6179 Part B — DRUG
    Once daily (QD) oral administration of 1200mg of NST-6179 for 12 weeks
  • Matched Placebo — OTHER
    Matched placebo for administration in Part A or Part B

Study Details

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.

Key Dates

Start date
Jan 15, 2024
Status verified
Jan 2025
Primary completion
Jun 30, 2025
Completion
Jun 30, 2025

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A-800 mg NST-6179
    up to 12 subjects
  • Experimental: Part A matched NST-6179 placebo
    up to 6 subjects
  • Experimental: Part B- 1200mg NST-6179
    up to 12 subjects
  • Experimental: Part B matched NST-6179 placebo
    up to 6 subjects

Primary Outcome Measure

To assess the safety and tolerability of NST-6179 [ Time Frame: Up to 14 Weeks ]

Central Contacts

Locations (13)

FacilityCityStateZIPSite coordinators
Mayo Clinic Scottsdale CampusScottsdaleArizona85259
John DiBaise, MD
University of California San Francisco Medical CenterSan FranciscoCalifornia94143
Kendall Beck, MD
MedStar Georgetown University HospitalWashington D.C.District of Columbia20007
Sukanya Subramanian
Emory University School of MedicineAtlantaGeorgia30322
Thomas Ziegler, MD
The University of Chicago Medical CenterChicagoIllinois60637
Carol Semrad, MD
Boston Children's HospitalBostonMassachusetts02115
Mark Puder, MD
Henry Ford HospitalDetroitMichigan48202
Syed-Mohammed Jafri, MD
Mayo Clinic Rochester CampusRochesterMinnesota55905
Manpreet Mundi, MD
Mount Sinai Medical CenterNew YorkNew York10029
Kishore Iyer, MD
Duke University Medical CenterDurhamNorth Carolina27710
Maria Segovia, MD
The Cleveland ClinicClevelandOhio44195
Don Kirby, MD
Vanderbilt University School of MedicineNashvilleTennessee37232
Dawn Adams
University of WashingtonSeattleWashington98195
Lei Yu, MD

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