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

NCT00550849 | Terminated Phase 1

• 1 other identifier: RTA 402-C-0701
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Liver Disease

Outcome Measures

Primary Outcomes (1)

• To evaluate the safety and tolerability of multiple-dose oral administration of RTA 402 in patients with hepatic dysfunction.

  28 days

Secondary Outcomes (1)

• To correlate the biological activity of RTA 402 with drug concentration in plasma.

  28 days

Study Arms (3)

1

EXPERIMENTAL

RTA 402

Drug: RTA 402

2

EXPERIMENTAL

RTA 402

Drug: RTA 402

3

EXPERIMENTAL

RTA 402

Drug: RTA 402

Interventions

RTA 402 DRUG

5 mg oral capsules

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogen: lead

Study Sites (1)

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• Thomas C. Marbury, MD

  Orlando Clinical Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2007
• First Posted: October 30, 2007
• Study Start: April 30, 2007
• Primary Completion: November 30, 2007
• Study Completion: November 30, 2007
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)