Study to Examine Multiple Doses of TMC647055 in Combination With Telaprevir

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess safety, tolerability, pharmacokinetics (how the drug is absorbed into the bloodstream) and antiviral activity of repeated doses of TMC647055 given in combination with telaprevir in HCV infected patients. TMC647055 is being investigated for the treatment of hepatitis C infection. Telaprevir has recently been approved in the USA and in Europe for the treatment of chronic hepatitis C infected patients.

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

Details

• Lead Sponsor: Janssen R&D Ireland

Criteria

Inclusion Criteria:

• genotype 1a or 1b HCV infection with HCV RNA level > 100,000 IU/mL

• A documented prior relapser patient to previous treatment regimens or treatment-naïve

• Patient must have documentation of a liver biopsy within 3 years before the screening visit or must agree to have a fibroscan/elastography examination within the screening period

• Patient is judged to be medically stable on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening

Exclusion Criteria:

• Evidence of liver cirrhosis

• Evidence of decompensated liver disease

• Evidence of any other cause of significant liver disease in addition to hepatitis C

• receiving or having received any treatment for HCV during the 6 months before screening

• History or evidence of current abuse of alcohol, barbiturate, amphetamine, recreational or narcotic drug use, which in the investigator's opinion would compromise subject's safety and/or compliance with the study procedures