MedTrace Logo

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

NCT02949375 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2019-08-09

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Placebo Comparator

Placebo gel capsule to be taken daily for 28 days

DRUG

Active Comparator:4.5mg GRI-0621

4.5mg GRI-0621 gel capsule to be taken daily for 28 days

DRUG

Active Comparator: 6.0mg GRI-0621

6.0mg GRI-0621 gel capsule to be taken daily for 28 days

Sponsors & Collaborators

  • GRI Bio Operations, Inc.

    lead INDUSTRY

Principal Investigators

  • Mpho K Kgomo, MBBCH · Department Head; Gastroenetrology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
FACTORIAL

Eligibility

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

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2018-11-30
Completion
2019-06-30

Countries

  • South Africa

Study Locations

More Related Trials

Entities

Diseases

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 NCT02949375 on ClinicalTrials.gov