Study in HCV-Infected Patients to Determine the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of JNJ-47910382

• Status: Terminated
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the safety, tolerability, pharmacokinetics (what the body does to the medication) and antiviral activity of JNJ-47910382 when administered in different dosing regimens in Caucasian genotype-1 chronic HCV-infected patients.

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

Details

• Lead Sponsor: Janssen R&D Ireland
• Treatments: Antiviral Agents

Criteria

Inclusion Criteria:

• Chronic (diagnosis of hepatitis C more than or 6 months before the screening period) HCV infection. Geno- and subtype should be determined or confirmed at screening, and should be 1a or 1b

• Never received (Peg) IFN, RBV or any other approved or investigational antiviral treatment for chronic HCV infection

• HCV RNA level of >100,000 IU/mL at screening (as assessed by standard quantitative in vitro nucleic acid amplification assay)

• Patients having good accessible veins

Exclusion Criteria:

• Evidence of liver cirrhosis or decompensated liver disease

• Patient coinfected with HIV-1 or HIV-2, or hepatitis A or B virus infection, or active tuberculosis at study screening

• Patient infected/coinfected with non-genotype-1 HCV at study screening

• Patient with any cardiac disease at screening, or any active clinically significant disease, or medical history or physical examination findings during screening

• Patient having uncontrolled/unstable disease such as diabetes, epilepsy, a manifest psychiatric disease, thyroid disease or disorders