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

Primary Purpose

Liver Disease

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

RTA 402

About this trial

This is an interventional treatment trial for Liver Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Orlando Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Arm Description

RTA 402

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00550849

First Posted

October 26, 2007

Last Updated

November 6, 2007

Sponsor

Reata Pharmaceuticals, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00550849

Brief Title

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

Official Title

Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Dose-Escalation Study to Assess the Safety, Tolerability, and Pharmacodynamics of RTA 402 (CDDO-Me) Administered Orally for 14 Days in Patients With Hepatic Dysfunction

Study Type

Interventional

2. Study Status

Record Verification Date

November 2007

Overall Recruitment Status

Terminated

Why Stopped

Enrollment discontinued after second cohort completed.

Study Start Date

April 2007 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

November 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Reata Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed Description

RTA 402 is a synthetic triterpenoid that is designed to suppress oxidative stress and inflammatory processes that play a significant role in a wide variety of diseases. It is a potent suppressor of inflammation and oxidative stress. Oxidative stress plays a role in the pathogenesis of hepatitis, and RTA 402 has demonstrated activity in a preclinical model of hepatitis, in addition to other models of inflammation. This is a 28-day, multiple-dose, dose-escalation study. It is anticipated that a total of 3 groups of 8 patients each will be enrolled, in which 6 patients in each group will be randomized to receive RTA 402, and 2 patients per group will be randomized to placebo (3:1). Patients will receive treatment daily for 14 days with a starting dose of 5mg, 25mg, or 50mg. Patients will return for follow up visits on Days 16 and 21, and complete end of study procedures on Day 28.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Liver Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

RTA 402

Arm Title

Arm Type

Experimental

Arm Description

RTA 402

Arm Title

Arm Type

Experimental

Arm Description

RTA 402

Intervention Type

Drug

Intervention Name(s)

RTA 402

Intervention Description

5 mg oral capsules

Intervention Type

Drug

Intervention Name(s)

RTA 402

Intervention Description

25 mg oral capsules

Intervention Type

Drug

Intervention Name(s)

RTA 402

Intervention Description

50 mg oral capsules

Primary Outcome Measure Information:

Title

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

Time Frame

28 days

Secondary Outcome Measure Information:

Title

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

Time Frame

28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas C. Marbury, MD

Organizational Affiliation

Orlando Clinical Research Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Orlando Clinical Research Center

City

Orlando

State/Province

Florida

ZIP/Postal Code

32809

Country

United States

12. IPD Sharing Statement

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

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