A Study in Healthy Adult Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of ABT-333

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-333 under nonfasting conditions in healthy adult subjects, and to determine the effect of single dose administration of ketoconazole on steady state ABT-333 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-333

Conditions
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HCV Infection

Intervention / Treatment
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* Drug: ABT-333
* Drug: 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: See above for main selection criteria

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>Healthy volunteers, receiving daily doses of 200 mg ABT-333 or placebo, BID for 10 days; and on Study Day 11 receiving a single dose of 200 mg ABT-333 or placebo + 400 mg ketoconazole | Drug: ABT-333<br>* Capsule, or powder drug substance from the capsule powder mixed in an alternate vehicle. For additional information refer to arm description.<br>Drug: ketoconazole<br>* Tablet, see arms for intervention description<br>Drug: placebo<br>* Capsule or powder drug substance from the capsule powder mixed in an alternative vehicle. For additional information refer to arm description.<br>|
| Other: 2<br>Healthy volunteers, receiving 400 mg ABT-333 or placebo, BID | Drug: ABT-333<br>* Capsule, or powder drug substance from the capsule powder mixed in an alternate vehicle. For additional information refer to arm description.<br>Drug: placebo<br>* Capsule or powder drug substance from the capsule powder mixed in an alternative vehicle. For additional information refer to arm description.<br>|
| Other: 3<br>Healthy volunteers, receiving 600mg ABT-333 or placebo, BID | Drug: ABT-333<br>* Capsule, or powder drug substance from the capsule powder mixed in an alternate vehicle. For additional information refer to arm description.<br>Drug: placebo<br>* Capsule or powder drug substance from the capsule powder mixed in an alternative vehicle. For additional information refer to arm description.<br>|
| Other: 4<br>Healthy volunteers, receiving 1000mg ABT-333 or placebo, BID | Drug: ABT-333<br>* Capsule, or powder drug substance from the capsule powder mixed in an alternate vehicle. For additional information refer to arm description.<br>Drug: placebo<br>* Capsule or powder drug substance from the capsule powder mixed in an alternative vehicle. For additional information refer to arm description.<br>|
| Other: 5<br>Healthy volunteers, receiving 1600mg ABT-333 or placebo, BID* *After review of the data from previous groups, and in accordance with the protocol, this arm was not dosed. | Drug: ABT-333<br>* Capsule, or powder drug substance from the capsule powder mixed in an alternate vehicle. For additional information refer to arm description.<br>Drug: placebo<br>* Capsule or powder drug substance from the capsule powder 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. |  | Approximately 1 week. | 
| 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 single dose administration of ketoconazole on steady state ABT-333 pharmacokinetics. |  | Approximately 1 week. |