Clinical trial NCT01448200 (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: ppi-668, placebo
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        In order to participate in the study, volunteers for Part I and patients for Part II must
        meet all of the following key entry criteria, as well as other entry criteria specified in
        the full protocol:

        Key Inclusion Criteria

          1. Male or female, between 18 and 65 years of age. Female patients must be surgically
             sterile or two years post-menopausal.

          2. Body Mass Index (BMI) 18 - 35 kg/m2

          3. In good health, in the judgment of the Principal Investigator

          4. Able and willing to comply with all protocol requirements and to sign an informed
             consent.

        Key Exclusion Criteria:

          1. Seropositive for HIV antibody, or HBV surface antigen (HBsAg) at Screen. Volunteer
             subjects for Part I must also be negative for HCV antibody.

          2. Any medical condition that may interfere with the absorption, distribution or
             elimination of study drug (PPI-668), or with the clinical and laboratory assessments
             in this study.

          3. Poorly controlled or unstable hypertension; or sustained systolic BP > 150 or
             diastolic BP > 95 at Screen.

          4. History of Diabetes Mellitus treated with insulin or hypoglycemic agents

          5. History of alcohol abuse or illicit drug use which, in the investigator's judgment,
             could interfere with a patient's compliance, with the protocol requirements or with
             the safety or efficacy assessments of the study

          6. History of malignancy unless the malignancy has been in complete remission and without
             additional medical or surgical interventions during the preceding three years

          7. No clinically significant laboratory abnormalities at Screen for healthy volunteers in
             Part I. For Screen laboratory parameters for HCV patients in Part II, refer to the
             'Additional Criteria for HCV Patients' below.

        Additional Key Entry Criteria for HCV patients (Part II):

          1. Clinical diagnosis of chronic hepatitis C, documented by:

               1. Clinical findings compatible with chronic hepatitis C, and absence of other known
                  liver disease

               2. Seropositive for HCV antibody or HCV RNA at least once previously, and at Screen

               3. Serum HCV RNA > 5 log10 IU/mL at Screen, by the PCR assay at the central study
                  laboratory

               4. HCV genotype-1 (1a or 1b, or non-subtypable genotype-1), or HCV genotype-2a or
                  genotype-3a

          2. ALT must be <5 x ULN at screen

          3. No previous treatment with interferon, pegIFN, or ribavirin for genotype-1 patients

          4. No history of signs or symptoms of decompensated liver disease

          5. Any of the following laboratory values at Screening will be exclusionary for study
             participation:

               -  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 >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 Screen