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Assessment of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SCH 900518 in Naive or Treatment-Experienced Subjects Infected With Hepatitis C Virus Genotype 1 (Protocol No. P04695)
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Inclusion criteria
Subject infected with HCV genotype 1 (any sub-type) virus who is:
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
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:
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)
Primary purpose
Allocation
Interventional model
Masking
41 participants in 4 patient groups
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Data sourced from clinicaltrials.gov
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