Study of the Safety & PK of INX-08189 in Chronically-infected HCV, Treatment-naïve Subjects

Exclusion Criteria

• •At the screening visit subjects will not meet any of the following criteria:
• •1. Advanced liver disease, cirrhosis, or with signs of decompensated liver disease such as variceal bleeding, ascites, hepatic encephalopathy, active jaundice (total bilirubin \> 2, or other evidence of decompensated liver disease;
• •2. Co-infection with HBV or HIV (positive test for HBsAg or anti-HIV Ab);
• •3. Acute cardiac ischemia, unstable heart disease or clinically symptomatic cardiac abnormalities apparent on ECG \& PE, or a QTcB interval at Visit 1 of ≥ to 450ms by Bazette's correction, or personal or family history of Torsades de pointes;
• •4. Use of the following medications concurrently or within the 30 days prior to Screening associated with QT prolongation: macrolides, antiarrhythmic agents, azoles, fluoroquinolones, \& tricyclic anti-depressants (methadone use allowed);
• •5. Use of immunosuppressive or immune-modulating agents (including corticosteroids \& immunosuppressive agents) or presence of an immunologically-mediated autoimmune disease (other than asthma) or history of organ transplantation (inhaled steroids for asthma \& topical steroid for minor skin conditions allowed);
• •6. Use of strong CYP3A4-inhibiting protease inhibitors (specifically atazanavir, indinavir, nelfinavir, saquinavir, \& ritonavir), strong CYP3A4 inhibitors (specifically clarithromycin, itraconazole, ketoconazole, nefazodone, telithromycin), or strong CYP3A4 inducers (specifically rifampin, efavirenz, etravirine, phenobarbital, phenytoin, \& carbamazepine);
• •7. Absolute NEUT count of \<1800 cells/mm3 (or \< 1500 cells/mm3 for African Americans), or platelet count \<130,000 cells/mm3, or hemoglobin \<11g/dl for women and \<13g/dl for men;
• •8. A history of abnormal thyroid function not adequately controlled (defined as TSH levels \< 0.8 x LLN or \> 1.2 x the ULN);
• •9. Serum creatinine concentration \> 1.5 times the upper limit of normal, or albumin \< 3g/dl;
• •10. Presence or history of severe, or uncontrolled, or hospitalization-requiring psychiatric disease including severe depression, suicide attempts or any severity of psychosis;
• •11. Any malignancy within the last 5 years other than treated cervical carcinoma in situ or treated basal cell carcinoma with no more than 20% risk of recurrence within 2 years;
• •12. Alcohol abuse (investigator assessment) within the past 2 years or an alcohol use pattern that will interfere with the study conduct;
• •13. Drug abuse (investigator assessment)within the last 6 months with exception of methadone;
• •14. Current lactation or breastfeeding;
• •15. Major surgery within 30 days prior Visit 1;
• •16. Participation in another clinical trial of an investigational drug or device within 6 months prior to visit 1;
• •17. Donation of blood or plasma within 30 days prior to Visit 1