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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00696904
First received: June 11, 2008
Last updated: October 19, 2010
Last verified: September 2010

June 11, 2008
October 19, 2010
June 2008
February 2009   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00696904 on ClinicalTrials.gov Archive Site
Analysis of variance of pharmacokinetic variables for subjects fasting or nonfasting. [ Time Frame: approximately 1 week ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of ABT-333 in Both Healthy Volunteers and Hepatitis C Virus (HCV) + Genotype 1 Infected Subjects
Not Provided

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.

Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
HCV Infection
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
133
Not Provided
February 2009   (final data collection date for primary outcome measure)

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

Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00696904
M10-351
Not Provided
Daniel Cohen, MD, Study Medical Director, Abbott
Abbott
Not Provided
Not Provided
Abbott
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP