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The purpose of this study is to determine the pharmacokinetic and safety profiles of an experimental HCV protease inhibitor with and without ritonavir in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | ABT-450 |
|
| 2 | Placebo Comparator | Placebo for ABT-450 |
|
| 3 | Active Comparator | ABT-450/ritonavir |
|
| 4 | Placebo Comparator | Placebo for ABT-450/placebo for ritonavir |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-450 | Drug | capsules,QD, one dose, see Arm Descriptions for more information |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (blood draws, pre- and post-dose) | 4 days | |
| Safety and Tolerability (ECGs, AEs, vitals, physical exams, routine labs) | 10 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adebayo A Lawal, MD | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 15981 | Waukegan | Illinois | 60085 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26710243 | Result | Menon RM, Klein CE, Podsadecki TJ, Chiu YL, Dutta S, Awni WM. Pharmacokinetics and tolerability of paritaprevir, a direct acting antiviral agent for hepatitis C virus treatment, with and without ritonavir in healthy volunteers. Br J Clin Pharmacol. 2016 May;81(5):929-40. doi: 10.1111/bcp.12873. Epub 2016 Feb 24. |
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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 |
|---|---|
| C585405 | paritaprevir |
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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| ritonavir |
| Drug |
capsules, QD, one dose, escalating doses, see Arm Descriptions for more information |
|
|
| placebo for ABT-450 | Drug | capsules, QD, one dose |
|
|
| Placebo for ritonavir | Drug | capsules, QD, one dose |
|
|
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |