Last updated on December 2016

A Study of CDI-31244: A Novel NNI in HV and HCV Infected Subjects


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Hepatitis C
  • Age: Between 18 - 65 Years
  • Gender: Male or Female
  • Other:
    Main Inclusion Criteria:
    HV and HCV INFECTED SUBJECTS:
    Male or female aged ≥ 18 to ≤ 65 years;
    Body mass index ≥ 18.5 to ≤ 35.0 kg/m2;
    Body weight ≥ 50 kg;
    Negative screening for alcohol and drugs of abuse;
    Normal results on 12-lead electrocardiogram (ECG);
    For females, negative result on a pregnancy test.
    HCV INFECTED SUBJECTS:
    HCV treatment-naïve subjects must have not received prior direct acting agent (DAA)
    treatment for hepatitis C infection;
    Documented clinical history compatible with chronic hepatitis C;
    HCV Genotype 1 by HCV genotyping performed at Screening;
    Plasma HCV RNA ≥ 5.0 log10 IU/mL at Screening;
    Laboratory evidence of no cirrhosis (negative liver biopsy or fibroscan or FibroTest,
    F2 or lower) within one year prior to study), if these are not available, do a
    FibroTest at screening, which must be F2 or lower.
    Main Exclusion Criteria:
    HV and HCV INFECTED SUBJECTS:
    Females who are pregnant or are lactating;
    Co-infected with hepatitis B virus (HBV, HBsAg positive) and/or human
    immunodeficiency virus (HIV);
    Abuse of alcohol and/or drugs that could interfere with adherence to study
    requirements as judged by the investigator;
    Positive screen result for drugs of abuse or alcohol on Day -1. Use of other
    investigational drugs within 60 days of dosing;
    Subject with intestinal malabsorption;
    Presence of out-of-range cardiac interval on the screening ECG or other clinically
    ignificant ECG abnormalities;
    Serum creatinine > upper limit of normal (ULN);
    Any clinically significant medical condition that, in the opinion of the
    investigator, would jeopardize the safety of the subject or impact the validity of
    the study results.
    HEALTHY VOLUNTEERS:
    Positive screen for anti-HCV antibody
    HCV INFECTED SUBJECTS:
    Clinical (in the opinion of the investigator) or laboratory evidence of cirrhosis;
    History or signs of decompensated liver disease: ascites, variceal bleeding, hepatic
    encephalopathy, spontaneous bacterial peritonitis, or other clinical signs of portal
    hypertension or hepatic insufficiency;
    History of hepatocellular carcinoma (HCC) or findings suggestive of possible HCC;
    Active clinically significant diseases.

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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