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The purpose of this study is to determine the bioavailability, pharmacokinetic and safety profiles of an experimental Hepatitis C virus (HCV) polymerase inhibitor in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. ABT-333 Capsule vs ABT-333 Tablet | Active Comparator | 400mg ABT-333 Tablet, QD, single dose vs eight 50mg ABT-333 Capsules, QD, single dose |
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| 2. ABT-333 Tablet | Active Comparator | ABT-333 400mg Tablet, QD, single ascending doses (1200mg, 1600mg, 2400mg) |
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| 3. Placebo | Placebo Comparator | Placebo tablets, QD, single ascending doses |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-333 Tablet | Drug | See Arm Description for more information. |
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| Measure | Description | Time Frame |
|---|---|---|
| To determine relative bioavailability of the ABT-333 tablet formulation compared to the FIH capsule formulation | 2 days post dosing | |
| To evaluate single dose safety and tolerability of a ABT-333 tablet formulation relative to placebo | 2 days post dosing | |
| To evaluate single dose pharmacokinetics of a ABT-333 tablet formulation | 2 days post dosing | |
| Pharmacokinetics | 5 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Cohen, MD | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 19441 | Waukegan | Illinois | 60085 | United States |
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| Placebo | Drug | See Arm Description for more information. |
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| ABT-333 Capsule | Drug | See arm description for more information |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C588260 | dasabuvir |
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