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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Other | Single dose of ABT-072, dose escalation ranging from 10 mg to 320 mg or placebo in healthy volunteers |
|
| 2 | Other | HCV positive subjects administered 160mg ABT-072 or placebo, multi-dose, QD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-072 | Drug | Capsule or powder drug substance from the capsule mixed in an alternative vehicle. For additional information refer to Arm Description. |
|
| 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 |
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Inclusion Criteria:
Criteria for Healthy Adults:
Criteria for HCV-infected Adults:
Exclusion Criteria:
Criteria for Healthy Adults:
Criteria for HCV-infected Adults:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Global Medical Information | Abbott Park | Illinois | 60064 | 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 | Capsule, or powder drug substance from the capsule mixed in an alternative vehicle. For additional information refer to Arm Description. |
|
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |