Study of ABT-333 in Both Healthy Volunteers and Hepatitis C Virus (HCV) + Genotype 1 Infected Subjects

• Analysis of pharmacokinetic variables and mean change in HCV RNA level from baseline. [ Time Frame: approximately 1 week or less ] [ Designated as safety issue: No ]
• Analysis of safety measures, including but not limited to tabulation of adverse events, physical exam, clinical lab results (include chemistry, hematology and urine) and vital signs. [ Time Frame: approximately 1 week ] [ Designated as safety issue: Yes ]

The purpose of this study is to assess the safety, tolerability, pharmacokinetics of ABT-333 in healthy volunteers and the antiviral activity in HCV infected subjects.

Phase 1, double-blind, randomized, placebo-controlled clinical trial in healthy and HCV genotype 1 infected adults to evaluate safety, tolerability, antiviral activity and pharmacokinetics of ABT-333.

• Drug: ABT-333
  Capsule, see arms for intervention description
  Other Name: ABT-333
• Drug: Placebo
  Capsule, see arms for intervention description
  Other Name: placebo

• 1
  Healthy volunteers, receiving 10-1200 mg ABT-333 or placebo, single dose
  Interventions:

  • Drug: ABT-333
  • Drug: Placebo
• 2
  HCV+ treatment-naive subjects receiving 100-300 mg ABT-333 or placebo, multi-dose, QD or BID
  Interventions:

  • Drug: ABT-333
  • Drug: Placebo
• 3
  Healthy volunteers, receiving 100 mg ABT-333, multi-dose, food effect
  Intervention: Drug: ABT-333

Inclusion Criteria:

• Main Selection Criteria for Healthy Volunteers:

  • Subject has provided written consent.
  • Subject is in general good health.
  • If female, subject is postmenopausal.
  • If female, subject is not pregnant and is not breast-feeding.

• Main Selection Criteria for HCV+ Subjects:

  • Subject is HAV-IgM, HBsAg or HIV Ab negative.
  • Subject is HCV genotype 1 with HCV RNA of > 50,000 IU/mL.
  • Subject is excluded if they have previously received antiviral therapy for HCV infection
  • Subjects must demonstrate chronic hepatitis C infection for at least 6 months prior to study enrollment
  • Subjects must have a prior liver biopsy with histology consistent with HCV induced liver damage, and with no evidence of cirrhosis or liver pathology due to any cause other than chronic HCV.

Exclusion Criteria:

See above for main selection criteria