A Phase 1a/1b Study of PPI-383 in Healthy Adults and Hepatitis C Patients

Part I volunteers (single and multiple dose) - key inclusion criteria * Healthy males * Age 18 to 55 years * Body mass index (BMI)18 to 32 kg/m2 Part II patients- key inclusion criteria * Males, or females of non-childbearing potential * Age 18 to 65 years * Chronic hepatitis C, and absence of other known liver disease * Seropositive for HCV antibody (HCV Ab) or HCV RNA at least once previously * Seropositive for HCV Ab at screening * Serum HCV RNA \> 5 log10 IU/mL at screening * HCV gt-1 * Treatment-naïve for hepatitis C: * BMI 18 to 35 kg/m2 * Otherwise in good health, without severe or clinically significant chronic or recurrent conditions requiring frequent medical intervention or continual pharmacologic management, except for anti-hypertensive use * No medical or psychosocial conditions that would potentially interfere with the subject's ability to comply with the study assessments or visit schedule. Part II patients - key exclusion criteria * Seropositive for human immunodeficiency virus (HIV) antibody or hepatitis B virus (HBV) surface antigen (HBsAg) * Signs or symptoms of decompensated liver disease * Evidence of cirrhosis or hepatocellular carcinoma * Diabetes Mellitus treated with insulin or hypoglycemic agents * Asthma requiring hospital admission within the preceding 12 months * History of alcohol abuse or illicit drug use which could interfere with a patient's compliance with the protocol requirements * Any of the following laboratory values at screening * Haemoglobin (Hgb) \<11 g/dL in women or 12 g/dL in men * White blood cell count \<4,000/mm3 * Absolute neutrophil count (ANC) \< 1800 per mm3 * Platelet count \<100,000 per mm3 * Serum creatinine \> upper limit of normal (ULN) at the central study laboratory * Serum albumin \<3.4 g/dL * Total bilirubin \>2.0 mg/dL * Clinically significant abnormality in the electrocardiograms (ECGs) at screening