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
  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)

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 01, 2014