Study to Assess the Safety, Tolerability, and Pharmacodynamics of RTA 402 in Patients With Hepatic Dysfunction

• Status: Terminated
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This study assesses the safety and tolerability of RTA 402 in patients with liver disease.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Reata Pharmaceuticals, Inc.

Criteria

Inclusion Criteria:

• Chronic liver disease.

• An estimated creatinine clearance of ≥ 60 mL/min.

• Serum alanine transaminase (ALT) or aspartate transaminase (AST) elevation must be above the upper limit of normal and below 5 times the upper limit of normal for patients with underlying liver disease; Child-Pugh score 5 to 9 (mild to moderate impairment).

• Patient must agree to practice effective contraception during the entire study period.

• Patient is willing to avoid strenuous physical activity from 24 hours prior to the study start, throughout the study, and for 2 weeks after the administration of the dose of study drug

• Patient is willing to avoid any alcohol consumption for the 24 hours prior to, and the 48 hours after administration of study drug; and avoid excessive alcohol consumption for the duration of the follow-up period.

• Patient must be able and willing to sign informed consent form.

Exclusion Criteria:

• Patient with clinically significant illnesses or recent hospitalization (within 60 days) which could compromise participation in the study in the judgment of the investigator, including: uncontrolled diabetes; active or uncontrolled infection; Confirmed diagnosis of HIV infection; uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within the past 6 months, or uncontrolled cardiac arrhythmia.

• Patient with any other auto immune disease, major chronic inflammatory disease or syndrome requiring significant treatment within the past year.

• Patients who are pregnant or breast feeding

• Patient receiving or has received any investigational drug within 30 days prior (or is currently using an investigational device)

• Patients with prior (within 4 weeks) or concurrent treatment with oral steroids, or protein-based therapy (i.e. TNFa)

• Patients with positive urine screen for drugs of abuse except when receiving a prescribed medication for a known indication

• Patients with Grade 2 or above hepatic encephalopathy.

• Patients who donated blood or experienced a significant blood loss (>450 mL) within 8 weeks of screening

• Patients with a history of bleeding varices within 12 weeks of screening.

• Patients with psychiatric illness or other condition that would limit compliance with study requirements.