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

Study Identifier
M10-351
CT.gov Identifier
NCT00696904
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Hepatitis
    • Study Drug
  • ABT-333
  • Placebo
    • Phase
    Phase 1
    Sex
    Female & Male
    Age
    18 - 65 Years
    Inclusion and Exclusion Criteria
    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

    Protocol Summary

    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.

    Study Locations

    No locations found.