A Single and Repeat Dose Trial in Participants With Hepatic Impairment

Phase 1/2 Unknown 54 enrolled Galecto Biotech AB Comac Medical · collab

RandomizedParallel-groupSingle-blindTreatment

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)

Timeline

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

Publications

Aslanis V, Gray M, Slack RJ, Zetterberg FR, Tonev D, Phung D, Smith B, Jacoby B, Schambye H, Krastev Z, Ungell AL, Lindmark B. Single-Dose Pharmacokinetics and Safety of the Oral Galectin-3 Inhibitor, Selvigaltin (GB1211), in Participants with Hepatic Impairment. Clin Drug Investig. 2024 Oct;44(10):773-787. doi: 10.1007/s40261-024-01395-7. Epub 2024 Oct 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Selvigaltin	Small molecule	100 mg	Oral

Indications

No indication recorded.