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A Single and Repeat Dose Trial in Participants With Hepatic Impairment

NCT05009680 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2023-05-11

No results posted yet for this study

Summary

This study is a a single (open-label) and repeat dose (randomised, placebo controlled) trial to assess the safety, tolerability and pharmacokinetics of GB1211 (Gal-3 inhibitor) in participants with hepatic impairment (Child Pugh B and Child Pugh C)

Conditions

  • Hepatic Impairment

Interventions

DRUG

GB1211

GB1211 is a galectin-3 inhibitor an orally available small molecule anti-fibrotic. It is administered orally twice a day

DRUG

Placebo

Placebo is administered orally twice a day

Sponsors & Collaborators

  • Comac Medical

    collaborator INDUSTRY

  • Galecto Biotech AB

    lead INDUSTRY

Principal Investigators

  • Zahariy Krastev, MD · Comac Medical

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-09
Primary Completion
2022-07-18
Completion
2023-07-04

Countries

  • Bulgaria

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05009680 on ClinicalTrials.gov