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To assess the safety, tolerability and pharmacokinetics of the ABT-072 tablet formulation administered as a single dose and then administered as multiple doses for 7 days. The effect of food on the safety, tolerability and pharmacokinetics of the ABT-072 tablet will also be evaluated.
The study consists of two substudies. Substudy 1 is a two-period, single ascending dose (SAD) and multiple ascending dose (MAD) blinded, randomized, placebo-controlled, non-fasting study. Designated groups that participate in Period 1 (SAD) will also participate in Period 2 (MAD). Substudy 2 is an open-label, randomized two-period, crossover study to examine the effect of food on the pharmacokinetics of ABT 072.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | ABT-072 tablet single ascending dose |
|
| 2 | Experimental | Placebo tablet |
|
| 3 | Experimental | ABT-072 tablet administered under non-fasting conditions. |
|
| 4 | Experimental | ABT-072 tablet administered under fasting conditions |
|
| 5 | Experimental | ABT-072 tablet multiple ascending dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-072 | Drug | See Arms information for a detailed description. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To determine the single and multiple dose safety and tolerability of the ABT-072 tablet formulation under non-fasting conditions. | Up to 14 days post last dose. | |
| To determine the single and multiple dose safety pharmacokinetics of the ABT-072 tablet formulation under non-fasting conditions. | 72 hours post last dose. |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the effect of food on the pharmacokinetics of the ABT-072 tablet formulation. | 72 hours post last dose. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Cohen | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 23742 | Waukegan | Illinois | 60085 | United States |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| C000625346 | ABT-072 |
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| Placebo | Drug | See Arms information for a detailed description. |
|
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |