Clinical trial NCT01081158 (phase 1, status: completed)
Conditions: hepatitis c, chronic
ICD codes: B18.2, B18.0, B18.1, B18.8, B18.9, K71.3, K71.4
Drugs: drug: sch 900518 biologic: peginterferon alfa-2b(pegintron), drug: sch 900518 biologic: peginterferon alfa-2b, drug: sch 900518 drug: ritonavir (rtv) biologic: peginterferon alfa-2b (pegintron), drug: sch 900518 drug: ritonavir (rtv) drug: ritonavir (rtv) biologic: peginterferon alfa-2b (pegintron)
SMILES: NC(=O)C1=NN(C=N1)[C@@H]1O[C@H](CO)[C@@H](O)[C@H]1O, NC(=O)C1=NN(C=N1)[C@@H]1O[C@H](CO)[C@@H](O)[C@H]1O, CC(C)[C@H](NC(=O)N(C)CC1=CSC(=N1)C(C)C)C(=O)N[C@H](C[C@H](O)[C@H](CC1=CC=CC=C1)NC(=O)OCC1=CN=CS1)CC1=CC=CC=C1, CC(C)[C@H](NC(=O)N(C)CC1=CSC(=N1)C(C)C)C(=O)N[C@H](C[C@H](O)[C@H](CC1=CC=CC=C1)NC(=O)OCC1=CN=CS1)CC1=CC=CC=C1
Eligibility criteria:

        Inclusion Criteria:

          -  Subject infected with HCV genotype 1 (any sub-type) virus who is:

               -  treatment naïve (eg. to interferon and ribavirin); or

               -  treatment experienced (non-responder and relapser): subject who received
                  interferon based therapy and continued to have detectable HCV RNA levels at the
                  end of follow-up, a subject who did not attain a 2 log decline in HCV RNA levels
                  at ~12 weeks and discontinued treatment, or subject who had no detectable viral
                  load while on treatment but had a detectable viral load post treatment.

          -  Subject with acceptable medical history, physical examination, and clinical laboratory
             evaluations consistent with CHC, compensated liver disease, and any associated
             diseases (diabetes, hypertension, etc).

          -  Subjects with an HCV RNA viral load of >10^5 copies/mL or equivalent international
             units

        BMI of 18 to 40 kg/m^2, men and women, ages 18-65 years inclusive

          -  Female must be non-lactating and have a negative pregnancy test at Screening and Day
             -1 and either be of nonchildbearing potential or if of childbearing potential, must be
             practicing effective double-barrier contraceptive methods from at least 2 weeks prior
             to Day -1 until 30 days after study completion.

          -  Male must be willing to practice barrier contraception from Day 1 through 3 months
             following treatment with SCH 900518.

          -  Subject must have an ECG recording showing no clinically significant findings at
             Screening.

          -  Subject with chronic stable hemophilia may enroll

          -  Subject on stable methadone treatment may enroll in this study (evaluation by
             investigator includes history of stable clinical management for >3 months).

        Exclusion Criteria:

          -  Subject has a significant acute or chronic medical illness which is not stable or is
             not controlled with medication (excluding prohibited medications).

          -  Subject has received an organ transplant.

          -  Subject has evidence of decompensated liver disease by physical exam (encephalopathy,
             ascites, caput medusae, etc).

          -  Subject has at anytime received an HCV NS3-specific protease inhibitor.

          -  Subject has a platelet count <80,000/mm^3 (confirmed by repeat analysis) at Screening.

          -  Subject has a serum hemoglobin of <10.0 g/dL (confirmed by repeat analysis) at
             Screening.

          -  Subject has a serum AST /ALT value >5 x ULN (confirmed by repeat analysis) at
             Screening.

          -  Subject has a serum alkaline phosphatase value >2 x ULN (confirmed by repeat analysis)
             at Screening.

          -  Two or more of the following criteria (confirmed by repeat analysis) at Screening:

               -  Total serum bilirubin >2.0 mg/dL.

               -  Serum albumin <3.5 g/dL.

               -  INR >1.7 (with the exception of hemophiliacs).

          -  Subject has a neutrophil count <1,000/mm^3 (confirmed by repeat analysis) at
             Screening.

          -  Creatinine clearance (as estimated by method of Cockcroft and Gault) less than 50
             mL/min at Screening.

          -  Subject who has a history of any clinically significant local or systemic infectious
             disease within 1 week prior to screening (other than HCV-infection).

          -  Male subject whose female partner intends on becoming pregnant within 3 months of the
             study.

          -  Subject is positive for HIV antibodies or hepatitis B surface antigen.

          -  Subject has a clinically significant allergy or intolerance to foods or drugs, or is
             known or suspected to have hypersensitivity to any ingredient in the investigational
             product.

          -  Subject has a clinically significant history of auto-immune hepatitis.

          -  Subject has used any investigational drugs or donated blood within 30 days prior to
             study drug administration.

          -  Subject who received any of the following treatments: known inhibitor of CYP3A4
             metabolism (2 weeks of prior to randomization), known inducer of CYP3A4 metabolism (2
             weeks prior to randomization) and treatment for HCV infection (1 month prior to
             randomization)