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The purpose of this study is to assess the safety, tolerability, pharmacokinetics of ABT-333 in healthy volunteers and the antiviral activity in HCV infected subjects.
Phase 1, double-blind, randomized, placebo-controlled clinical trial in healthy and HCV genotype 1 infected adults to evaluate safety, tolerability, antiviral activity and pharmacokinetics of ABT-333.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Other | Healthy volunteers, receiving 10-1200 mg ABT-333 or placebo, single dose |
|
| 2 | Other | HCV+ treatment-naive subjects receiving 100-300 mg ABT-333 or placebo, multi-dose, QD or BID |
|
| 3 | Other | Healthy volunteers, receiving 100 mg ABT-333, multi-dose, food effect |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-333 | Drug | Capsule, see arms for intervention description |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Analysis of pharmacokinetic variables and mean change in HCV RNA level from baseline. | approximately 1 week or less | |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Analysis of variance of pharmacokinetic variables for subjects fasting or nonfasting. | approximately 1 week |
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Inclusion Criteria:
Main Selection Criteria for Healthy Volunteers:
Main Selection Criteria for HCV+ Subjects:
Exclusion Criteria:
See above for main selection criteria
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26597291 | Result | Mensing S, Polepally AR, Konig D, Khatri A, Liu W, Podsadecki TJ, Awni WM, Menon RM, Dutta S. Population Pharmacokinetics of Paritaprevir, Ombitasvir, Dasabuvir, Ritonavir, and Ribavirin in Patients with Hepatitis C Virus Genotype 1 Infection: Combined Analysis from 9 Phase 1b/2 Studies. AAPS J. 2016 Jan;18(1):270-80. doi: 10.1208/s12248-015-9846-1. Epub 2015 Nov 23. |
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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 |
|---|---|
| C588260 | dasabuvir |
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| Placebo |
| Drug |
Capsule, see arms for intervention description |
|
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |