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

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ClinicalTrials.gov Identifier: NCT00696904
Recruitment Status : Completed
First Posted : June 13, 2008
Last Update Posted : November 21, 2017
Sponsor:
Information provided by:
AbbVie

Brief 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.

Condition or disease Intervention/treatment Phase
HCV Infection Drug: ABT-333 Drug: Placebo Phase 1

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 133 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Study Start Date : June 2008
Primary Completion Date : February 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Dasabuvir
U.S. FDA Resources

Arm Intervention/treatment
1
Healthy volunteers, receiving 10-1200 mg ABT-333 or placebo, single dose
Drug: ABT-333
Capsule, see arms for intervention description
Drug: Placebo
Capsule, see arms for intervention description
2
HCV+ treatment-naive subjects receiving 100-300 mg ABT-333 or placebo, multi-dose, QD or BID
Drug: ABT-333
Capsule, see arms for intervention description
Drug: Placebo
Capsule, see arms for intervention description
3
Healthy volunteers, receiving 100 mg ABT-333, multi-dose, food effect
Drug: ABT-333
Capsule, see arms for intervention description



Primary Outcome Measures :
  1. Analysis of pharmacokinetic variables and mean change in HCV RNA level from baseline. [ Time Frame: approximately 1 week or less ]
  2. 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 ]

Secondary Outcome Measures :
  1. Analysis of variance of pharmacokinetic variables for subjects fasting or nonfasting. [ Time Frame: approximately 1 week ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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