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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
History of Changes
  Purpose

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 Intervention Phase
HCV Infection
 Drug: ABT-333
Drug: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Analysis of variance of pharmacokinetic variables for subjects fasting or nonfasting. [ Time Frame: approximately 1 week ] [ Designated as safety issue: No ]

Enrollment: 133
Study Start Date: June 2008
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Healthy volunteers, receiving 10-1200 mg ABT-333 or placebo, single dose
 Drug: ABT-333
Capsule, see arms for intervention description
Other Name: ABT-333
Drug: Placebo
Capsule, see arms for intervention description
Other Name: placebo
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
Other Name: ABT-333
Drug: Placebo
Capsule, see arms for intervention description
Other Name: placebo
3
Healthy volunteers, receiving 100 mg ABT-333, multi-dose, food effect
 Drug: ABT-333
Capsule, see arms for intervention description
Other Name: ABT-333

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00696904

Locations
United States, Illinois
Global Medical Information
Abbott Park, Illinois, United States, 60064
Sponsors and Collaborators
Abbott
  More Information

No publications provided

Responsible Party: Daniel Cohen, MD, Study Medical Director, Abbott
ClinicalTrials.gov Identifier: NCT00696904     History of Changes
Other Study ID Numbers: M10-351
Study First Received: June 11, 2008
Last Updated: October 19, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis C
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
 RNA Virus Infections
Hepatitis
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on June 13, 2013