Trial to Examine the Effect of Two Doses of GRI-0621 in Patients With Chronic Liver Disease

Summary

Primary objectives: To evaluate the change in serum alanine transaminase \[ALT\] levels from Day 0 to Day 28, following daily doses of 4.5 or 6mg of GRI-0621 compared to placebo, in patients with chronic liver disease and elevated serum levels of ALT. Serum ALT level will be used as a marker of liver inflammation. To assess the safety and tolerability of GRI-0621 at these two doses. Secondary objectives: To assess the change in serum aspartate transaminase \[AST\] levels from baseline to Day 28, following daily doses of 4.5 or 6mg of GRI-0621 or matching placebo, in patients with chronic liver disease and elevated serum levels of AST. Serum AST level will be used as a second marker of liver inflammation. To evaluate the response to 4.5mg GRI-0621 versus 6mg GRI-0621 in terms of the change in serum ALT levels from baseline measured at the different trial time points. To assess changes in serum cytokeratin 18 \[CK-18\] levels from baseline to Day 28, following daily doses of 4.5 or 6mg of GRI-0621 or matching placebo, in patients with chronic liver disease. Serum CK-18 is used as a marker of hepatocyte cell death due to either necrosis or apoptosis. To measure Natural Killer T lymphocyte \[NKT\] cell activity at baseline and at Day 28 following daily doses of 4.5 or 6mg of GRI-0621 or matching placebo. To describe the steady-state pharmacokinetics \[PK\] of GRI-0621 in patients with chronic liver disease. Exploratory objectives: To assess the effect, if any, that the investigational product may have on serum triglyceride levels.

Timeline

Start

2015-09

Primary completion

2018-11

Completion

2019-06

Outcome

Outcome not reported

Stopped: “Administrative decision”

Drugs

Indications