NCT05009680

A Single and Repeat Dose Trial in Participants With Hepatic Impairment

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)

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Galecto Biotech AB · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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)

Detailed 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).

Conditions

• Hepatic Impairment

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-09-09
• Primary completion: 2022-07-18
• Completion: 2023-07-04
• First posted: 2021-08-17
• Last updated: 2023-05-11

Locations

4 sites across 1 country: Bulgaria