A Study of ABT-072 in Healthy and Hepatitis C Virus Genotype 1-Infected Adults

Study Overview
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Brief Summary
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To evaluate the safety, tolerability and pharmacokinetics of ABT-072 in healthy volunteers and its anti-viral activity in HCV infected subjects.

Detailed Description
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A blinded, randomized, placebo-controlled trial to study the safety, tolerability, antiviral activity and pharmacokinetic profiles of ABT-072 in healthy and HCV genotype-1 infected adults.

Conditions
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Hepatitis C

Intervention / Treatment
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* Drug: ABT-072
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Criteria for Healthy Adults: Informed consent has been obtained Subject is in general good health If female, then postmenopausal If female, then not pregnant If male, must be surgically sterile or both he and the partner must use birth control Body Mass Index is 18 to 29, inclusive Criteria for HCV-infected Adults: Infected with HCV for at least 6 months as shown by either detectable HCV RNA or reactive antibody, or liver biopsy with pathology indicative of HCV infection, or disclosure of a risk factor Subject is infected with HCV genotype 1 with detectable HCV RNA of > 50,000 IU/mL Exclusion Criteria: Criteria for Healthy Adults: If female, then pregnant or breast feeding Positive HAV-IgM, HBs-Ag, HCV Ab or HIV Ab Within 6 months of start of study, drug or alcohol abuse and use of nicotine products Alcohol intake within 48 hours prior to study drug administration Criteria for HCV-infected Adults: Need for prescription or over-the-counter medication Child Pugh score > 5 or clinical evidence of cirrhosis No other cause for liver disease other than HCV infection ALT or AST > 4 x ULN Creatinine > ULN Clinically significant abnormal ECG HCV RNA levels above the level of assay quantification TSH values outside normal range

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>Single dose of ABT-072, dose escalation ranging from 10 mg to 320 mg or placebo in healthy volunteers | Drug: ABT-072<br>* Capsule or powder drug substance from the capsule mixed in an alternative vehicle. For additional information refer to Arm Description.<br>Drug: placebo<br>* Capsule, or powder drug substance from the capsule mixed in an alternative vehicle. For additional information refer to Arm Description.<br>|
| Other: 2<br>HCV positive subjects administered 160mg ABT-072 or placebo, multi-dose, QD | Drug: ABT-072<br>* Capsule or powder drug substance from the capsule mixed in an alternative vehicle. For additional information refer to Arm Description.<br>Drug: placebo<br>* Capsule, or powder drug substance from the capsule mixed in an alternative vehicle. For additional information refer to Arm 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. |  | 2 weeks | 
| 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. |  | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phase 1