Clinical trial NCT01554085 (phase 1, status: terminated)
Conditions: hepatitis c, chronic
ICD codes: B18.2, B18.0, B18.1, B18.8, B18.9, K71.3, K71.4
Drugs: als-002158, placebo
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Reason stopped: 
    als-2158 showed insufficient antiviral activity to warrant proceeding with further clinical
    development.
  
Eligibility criteria:

        Inclusion Criteria:

          -  Subject has provided written consent.

          -  Subject is in good health as deemed by the investigator

          -  Creatinine clearance of greater than 50 mL/min (Cockcroft- Gault).

          -  Male or female, 18-55 years of age for HV and 18-65 years of age for subjects with
             CHC.

          -  Body mass index (BMI) 18-32 kg/m2 inclusive for HV and 18-36 kg/m2 for subjects with
             CHC, minimum weight 50 kg in both populations.

          -  A female is eligible to participate in this study if she is of non-childbearing
             potential.

          -  If male, subject is surgically sterile or practicing specific forms of birth control.

        Additional inclusion criteria for subjects with CHC genotype 1 infection:

          -  Positive HCV antibody and a positive HCV RNA at screening.

          -  Documentation of CHC infection of greater than 6 months duration at screening.

          -  CHC genotype 1 infection at screening.

          -  HCV RNA viral load ≥ 105 and ≤ 108 IU/mL using a sensitive quantitative assay

          -  Liver biopsy within two years or Fibroscan evaluation within 6 months prior to
             screening that clearly excludes cirrhosis. Fibroscan liver stiffness score must be <
             12 kPa.

          -  Absence of hepatocellular carcinoma as indicated by an abdominal ultrasound scan
             during screening.

          -  No prior treatment for CHC.

          -  Absence of history of clinical hepatic decompensation.

          -  Laboratory values include:

               -  prothrombin time < 1.5 × ULN.

               -  platelets > 120,000/mm3.

               -  albumin > 3.5 g/dL, bilirubin < 1.5 mg/dL at screening (subjects with documented
                  Gilbert's disease allowed).

               -  Serum ALT concentration < 5 × ULN.

               -  Alpha Fetoprotein (AFP) concentration ≤ ULN. If AFP is ≥ ULN, absence of a
                  hepatic mass must be demonstrated by ultrasound within the screening period.

        Exclusion Criteria:

          -  Clinically significant cardiovascular, respiratory, renal, gastrointestinal,
             hematologic, neurologic, thyroid, or any uncontrolled medical illness or psychiatric
             disorder.

          -  Positive test for HAV IgM, HBsAg, HCV Ab (HV only), or HIV Ab.

          -  Abnormal screening laboratory results that are considered clinically significant by
             the investigator.

          -  Clinically significant drug allergy such as, but not limited to, sulfonamides and
             penicillins, including those experienced in previous trials with experimental drugs.

          -  Participation in an investigational drug trial or having received an investigational
             vaccine within 30 days or 5 half lives (whichever is longer) prior to receiving study
             medication.

          -  Clinically significant blood loss or elective blood donation of significant volume.

          -  Laboratory abnormalities including:

               -  Thyroid Stimulating Hormone (TSH) >ULN.

               -  Hematocrit < 34 %.

               -  White blood cell counts < 3,500/mm3.

          -  For healthy volunteers, history of regular use of tobacco.

          -  The subject has a positive pre-study drug screen.