A Study in Healthy Adult Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetic Profiles of Multiple Doses of ABT-072 Used to Treat Hepatitis C

Study Overview
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Brief Summary
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The purpose of this study is to determine multiple dose safety, tolerability and pharmacokinetics of ABT-072 under nonfasting conditions in healthy adult subjects, and to determine the effect of single dose administration of ketoconazole on steady state ABT-072 pharmacokinetics.

Detailed Description
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Phase 1, Blinded, Randomized, Placebo-controlled Study in Healthy Adult Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetic Profiles of Multiple Doses of ABT-072

Conditions
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HCV Infection

Intervention / Treatment
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* Drug: ABT-072
* Other: ketoconazole
* 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 for at least 2 years or surgically sterile. If female, subject is not pregnant and is not breast-feeding. Male or female between 18 and 55 years old, inclusive. If male, subject must be surgically sterile or practicing at least 1 method of birth control. Body Mass Index (BMI) is 18 to 29, inclusive. Exclusion Criteria: Use of medications including over the counter and vitamines. Abuse of alcohol, drugs, or nicotine. Current diseases or disorders. History of cardiac disease. If after consideration by the investigator, for any reason, that you are unsuitable to receive ABT-072.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>Healthy volunteers, receiving daily dose of 80 mg ABT-072 or placebo, QD for 10 days; and on Study Day 11 receiving a single dose of 80 mg ABT-072 or placebo + 400 mg ketoconazole | Drug: ABT-072<br>* Powder contents from capsules mixed in an alternative vehicle, for additional information refer to Arm Description.<br>Other: ketoconazole<br>* Tablet, see Arm Description for intervention information.<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>Healthy volunteers, receiving 160 mg ABT-072 or placebo, QD for 10 days. | Drug: ABT-072<br>* Powder contents from capsules 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: 3<br>Healthy volunteers, receiving 320 mg ABT-072 or placebo, QD for 10 days. | Drug: ABT-072<br>* Powder contents from capsules 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 results. |  | Study Days 1-13 | 
| 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. |  | Study Days -2 through 39 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of single dose administration of ketoconazole on steady state ABT-072 pharmacokinetics. |  | Study Day 11-13 |