Clinical trial NCT01590407 (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: als-002200, placebo
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  Subject has provided written consent.

          -  In the investigator's opinion, the subject is able to understand and comply with
             protocol requirements, instructions, and protocol stated restrictions and is likely to
             complete the study as planned.

          -  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 for greater than 6 months 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 ultrasound scan conducted
             during screening

          -  No prior treatment for CHC

          -  Absence of history of clinical hepatic decompensation.

          -  Laboratory values include:

               -  Prothrombin time < 1.5x 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 alanine aminotransferase (ALT) concentration < 5 x ULN

               -  Alpha Fetoprotein (AFP) concentrations ≤ 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.

          -  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 study
             medication.

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

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

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

          -  Laboratory abnormalities including:

               -  Thyroid Stimulating Hormone (TSH) > ULN

               -  Hematocrit < 34 %

               -  White blood cell counts < 3,500/mm3