A Pharmacokinetics/Pharmacodynamics Study of SCH 900518 in Previously Untreated Subjects With Genotype 1 Chronic Hepatitis C (Protocol No. P05104AM2)(COMPLETED) (NEXT-1)

Inclusion Criteria:

• Adult subjects with CHC HCV genotype 1 with no previous treatment for CHC
• 18 to 55 years of age
• Weight between 40 and 125 kg
• Previously documented CHC genotype 1 infection
• Liver biopsy within 2 years of Screening with histology consistent with chronic hepatitis C and no evidence of bridging fibrosis or cirrhosis
• Subject and subject's partner(s) must each agree to use acceptable methods of contraception for at least 2 weeks prior to Day 1 and continue until at least 6 months after last dose of study drug
• Subjects must be willing to give written informed consent

Exclusion Criteria:

• Prior treatment for hepatitis C other than herbal remedies
• HIV positive or known to be co-infected with hepatitis B
• Medically significant gallbladder or hepatobiliary findings on Screening ultrasound
• Use of any known significant inducers or substrates of CYP3A4 two weeks prior to start of study medications
• Use of herbal supplements (Milk Thistle permitted)
• Diabetic and hypertensive subjects with clinically significant ocular examination findings
• Current moderate or severe depression

• History of depression associated with any of the following:

  • Hospitalization for depression
  • Electroconvulsive therapy for depression.
  • Depression that resulted in a prolonged absence from work and/or significant disruption of daily functions
• Suicidal or homicidal ideation and/or attempt
• History of severe psychiatric disorders
• Past history or current use of lithium
• Clinical diagnosis of substance abuse of alcohol, intravenous drugs, inhalational (not including marijuana), psychotropics, narcotics, cocaine use, prescription or over-the-counter drugs within 5 years of Day 1
• Past or current use of opiate agonist substitution therapy
• Any known pre-existing medical condition (CNS, cardiac, pulmonary, immune mediated) that could interfere with the subject's participation in and completion of the study
• Active clinical gout within the last year
• Hemoglobinopathy or coagulopathy
• Myelodysplastic syndromes
• Organ transplants other than cornea and hair
• Poor venous access that precludes routine peripheral blood sampling or an indwelling venous catheter
• Subjects with a history of gastric surgery (eg, stapling, banding, bypass) or subjects with a history of malabsorption disorders (eg, celiac sprue disease)
• Evidence of active or suspected malignancy, or a history of malignancy, within the last 5 years (except adequately treated basal cell carcinoma of the skin). Subjects under evaluation for malignancy are not eligible.
• Subjects who are pregnant or nursing
• Subjects who intend to become pregnant during the study period
• Male subjects with partners who are, or intend to become, pregnant during the study period