Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED Phase 1

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

NCT04332432 · View on ClinicalTrials.gov ↗

Study Summary

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.

Conditions Studied

Interventions

  • DRUG belapectin

Study Locations (4)

Texas

  • Texas Liver Institute — San Antonio
  • Pinnacle Clinical Research — San Antonio

California

  • Inland Empire Clinical Trials — Rialto

Florida

  • Clinical Pharmacology of Miami, Inc — Miami

Trial Details

FieldValue
Enrollment Target 38 participants
Start Date 2020-06-16
Est. Completion 2022-03-09
Phase Phase 1

Sponsor

Galectin Therapeutics

1 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04332432

The ClinicalTrials.gov registry entry for NCT04332432 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Galectin Therapeutics, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Hepatic Impairment appearing as the primary indexed condition, and to 1 intervention — of which belapectin is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04332432 reports 4 study locations spanning 3 distinct geographic areas — top geographies include Texas, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04332432 about?

NCT04332432 is a clinical study titled "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". 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.

What is the current status of trial NCT04332432?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2020-06-16. Estimated completion is 2022-03-09.

What conditions does trial NCT04332432 study?

This clinical trial studies the following conditions: Hepatic Impairment. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04332432?

The interventions under investigation include: belapectin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04332432?

This trial is sponsored by Galectin Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04332432 being conducted?

This trial has 4 study locations across California, Florida, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial