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A Single and Repeat Dose Trial in Participants With Hepatic Impairment

Hepatic Impairment Clinical Trial

Official title:
GULLIVER-2 - A Single (Open-label) and Repeat Dose (Randomised, Placebo-controlled) Trial to Assess the Safety, Tolerability and Pharmacokinetics of GB1211 in Participants With Hepatic Impairment (Child Pugh B & C)

Clinical Trial 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)

Clinical Trial Description

PART 1 A single dose, open-label safety and PK study of GB1211 administered to participants with moderate hepatic impairment (Child Pugh B) and to matched healthy participants (controls). PART 2 A randomised, double-blind, placebo-controlled study in participants with moderate hepatic impairment (Child Pugh B). GB1211 or placebo will be administered daily for 12 weeks. PART 3 A single dose, open-label safety and PK study of GB1211 administered to participants with severe hepatic impairment (Child Pugh C) and to healthy participants (controls). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05009680
Study type Interventional
Source Galecto Biotech AB
Contact
Status Active, not recruiting
Phase Phase 1/Phase 2
Start date September 9, 2021
Completion date July 4, 2023
View Details
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