A Pilot Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of ABT-450 With Ritonavir (ABT-450/r) Dosed in Combination With ABT-072 and Ribavirin (RBV)

Study Identifier
M12-267
CT.gov Identifier
NCT01221298
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Scientific Result Summary
Available Language(s): English
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Study Details

Medical Condition
  • Hepatitis
    • Study Drug
  • ABT-450
  • ABT-072
  • Ribavirin
  • Ritonavir
    • Phase
    Phase 2
    Sex
    Female & Male
    Age
    18 - 65 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Chronic hepatitis C, genotype 1 infection with interleukin 28B (IL28B) rs12979860 genotype C/C. * Liver biopsy within 3 years with histology consistent with hepatitis C virus (HCV) - induced liver damage, with no evidence of cirrhosis or liver pathology due to any cause other than chronic HCV. * Treatment naïve male or female between the ages of 18 and 65. * Females must be postmenopausal for at least 2 years or surgically sterile. * Be in a condition of general good health, as perceived by the investigator, other than hepatitis C virus infection. * Body mass index 18 to \< 35 kg/m\^2 .
    Exclusion Criteria:
    * Significant sensitivity to any drug. * Use of herbal supplements within 2 weeks prior to study drug dosing. * Positive screen for certain drugs or alcohol. * Positive hepatitis B surface antigen or anti-human immunodeficiency virus (HIV) antibody. * Use of strong cytochrome P450 3A (CYP3A), cytochrome P450 2C8 (CYP2C8), and organic anion transporting polypeptide 1B1 (OATP1B1) enzyme inducers or inhibitors within 1 month of dosing. * Prior treatment with any investigational or commercially available anti-hepatitis C virus agents. * Abnormal laboratory tests. * Cirrhosis or extensive bridging fibrosis. * History of cardiac disease.

    Protocol Summary

    The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of ABT-450 with ritonavir (ABT-450/r) dosed in combination with ABT-072 and ribavirin (RBV) in treatment-naïve participants with genotype 1 chronic hepatitis C virus (HCV) infection.

    Study Locations

    Location
    Status
    Location
    Site Reference ID/Investigator# 41128
    Los Angeles, California, United States, 90048
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 42262
    Chicago, Illinois, United States, 60637
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 41127
    San Antonio, Texas, United States, 78215
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 43182
    Seattle, Washington, United States, 98101
    Status
    Not applicable