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

Study Overview
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Brief Summary
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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
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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.

Conditions
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HCV Infection

Intervention / Treatment
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* Drug: ABT-333
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of pharmacokinetic variables and mean change in HCV RNA level from baseline. |  | approximately 1 week or less | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of variance of pharmacokinetic variables for subjects fasting or nonfasting. |  | approximately 1 week |