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NCT04332432

A Single-dose, Open-label, Pharmacokinetic Study of Belapectin (GR-MD-02) in Subjects With Normal Hepatic Function and Subjects With Varying Degrees of Hepatic Impairment

Completed Phase 1 Last updated 28 March 2022
What this trial tests

Phase 1 trial testing belapectin in Hepatic Impairment in 38 participants. Completed in 9 March 2022.

Timeline
16 June 2020
Primary endpoint
9 March 2022
9 March 2022

Quick facts

Lead sponsorGalectin Therapeutics Inc.
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment38
Start date16 June 2020
Primary completion9 March 2022
Estimated completion9 March 2022
Sites4 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Galectin Therapeutics Inc. — full company profile →

Who can join

Adults 18 to 75, any sex, with Hepatic Impairment. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study will assess the pharmacokinetics of belapectin in subjects with mild, moderate, or severe hepatic impairment according to 3 different Child-Pugh categories: mild, moderate, or severe impairment, compared to matched healthy control subjects.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Inhibition of galectins in cancer: Biological challenges for their clinical application.
    Laderach DJ, Compagno D. · · 2022 · cited 26× · PMID 36703969 · DOI 10.3389/fimmu.2022.1104625
  2. Galectins in the Pathogenesis of Common Retinal Disease.
    Caridi B, Doncheva D, Sivaprasad S, Turowski P. · · 2021 · cited 6× · PMID 34079467 · DOI 10.3389/fphar.2021.687495
  3. Glycobiology-driven therapeutic targeting of glycan-binding proteins: mechanisms, diseases, and clinical translation.
    Popatia AM, Sharanek A, Jahani-Asl A. · · 2026 · PMID 42248861 · DOI 10.1038/s41392-026-02768-4

Verify or expand the search:

Other trials of belapectin

Trials testing the same drug.

Other recruiting trials for Hepatic Impairment

Currently open trials in the same condition.

Other Galectin Therapeutics Inc. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04332432.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing