Study of ABT-333 in Both Healthy Volunteers and Hepatitis C Virus (HCV) + Genotype 1 Infected Subjects
- Registration Number
- NCT00696904
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 133
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Placebo HCV+ treatment-naive subjects receiving 100-300 mg ABT-333 or placebo, multi-dose, QD or BID 1 Placebo Healthy volunteers, receiving 10-1200 mg ABT-333 or placebo, single dose 3 ABT-333 Healthy volunteers, receiving 100 mg ABT-333, multi-dose, food effect 1 ABT-333 Healthy volunteers, receiving 10-1200 mg ABT-333 or placebo, single dose 2 ABT-333 HCV+ treatment-naive subjects receiving 100-300 mg ABT-333 or placebo, multi-dose, QD or BID
- Primary Outcome Measures
Name Time Method 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. approximately 1 week Analysis of pharmacokinetic variables and mean change in HCV RNA level from baseline. approximately 1 week or less
- Secondary Outcome Measures
Name Time Method Analysis of variance of pharmacokinetic variables for subjects fasting or nonfasting. approximately 1 week