Safety Study of INX-08189, Pharmacokinetic and Pharmacodynamic With Ribavirin and Food Effect Study, in Chronically-infected Genotype 1 Hepatitis C Virus, Treatment-naïve Subjects

screening visit (Visit1), subject criteria:

Advanced liver disease, cirrhosis, or signs of decompensated liver disease such as variceal bleeding, ascites, hepatic encephalopathy, active jaundice defined by a total bilirubin \> 2, or other evidence of decompensated liver disease;

Co-infection with hepatitis B virus (HBV)or human immunodeficiency virus (HIV) (positive test for hepatitis B surface antigen \[HBsAg\] or anti-HIV antibody \[Ab\]);

Acute cardiac ischemia, unstable heart disease or clinically symptomatic cardiac abnormalities apparent on electrocardiogram (ECG) and physical exam, or a QTcF interval at Visit 1 of ≥ 450 ms by Fridericia's correction, or a personal or family history of Torsades de pointes;

Use of the following medications concurrently or within the 30 days prior Screening (Visit 1) associated with QT prolongation: macrolides, antiarrhythmic agents, azoles, fluoroquinolones, and tricyclic anti-depressants (note: methadone use is not allowed);

Use of immunosuppressive or immune-modulating agents (including corticosteroids and immunosuppressive agents) or presence of an immunologically-mediated autoimmune disease (other than asthma) or history of solid organ or bone marrow transplantation (note: inhaled steroids for asthma and topical steroid for minor skin conditions allowed and washout period for PO/IM/IV corticosteroid use is 8 weeks; washout periods for other immunosuppressives determined by Medical Monitor);

Use of strong Cytochrome P (CYP)3A4-inhibiting protease inhibitors (specifically atazanavir, indinavir, nelfinavir, saquinavir, and ritonavir), strong CYP3A4 inhibitors (specifically clarithromycin, itraconazole, ketoconazole, nefazodone, telithromycin), or strong CYP3A4 inducers (specifically rifampin, efavirenz, etravirine, phenobarbital, phenytoin, and carbamazepine);

Absolute neutrophil count of \< 1,800 cells/mm3, or platelet count \< 130,000 cells/mm3, or hemoglobin \< 12 g/dl for women and \< 13 g/dl for men, or a history of anemia, sickle cell anemia, or thalassemia; (note: if baseline value within 5% of minimum qualifying value, 1 re-test allowed for the purpose of qualifying for study);

A history of abnormal thyroid function that is not adequately controlled (defined as thyroid stimulating hormone \[TSH\] levels \< 0.8 x lower limit of normal \[LLN\] or \> 1.2 x the upper limit of normal \[ULN\]);

Serum creatinine concentration ≥ 1.5 times the upper limit of normal, or albumin ≤ 3 g/dl;

Any history of suicide attempt, receipt of professional counseling for suicidal ideation or any current suicidal ideation, or other serious psychiatric disorders (ie, bipolar disorder, severe depression, psychosis) requiring or having required hospitalization or medication

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;

Alcohol abuse within the past 2 years or an alcohol use pattern that will interfere with the study conduct;

Drug abuse within the last 6 months.

Current lactation or breastfeeding;

Major surgery within 30 days prior Visit 1;

Participation in another clinical trial of an investigational drug or device within 6 months prior to visit 1 unless that prior participation involved exposure only to placebo by clear and available documentation;

Donation of blood or plasma within 30 days prior to Visit 1.

What this study is about