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Study of ABT-267 in both healthy volunteers and Hepatitis C virus (HCV) genotype 1 infected subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Ascending Dose (SAD) | Placebo Comparator | Healthy volunteers, receiving single ascending doses of ABT-267 or placebo. |
|
| Multiple Ascending Dose (MAD) | Placebo Comparator | Healthy volunteers, receiving multiple ascending doses of ABT-267 or placebo, OR, multiple doses of ABT-267 + single dose of a Cytochrome P450 inhibitor or placebo + single dose of a Cytochrome P450 inhibitor. |
|
| Food Effect (FE) | Active Comparator | Healthy volunteers, receiving ABT-267, multi-dose, food effect. |
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| Antiviral Activity | Placebo Comparator | HCV genotype 1-infected treatment naïve subjects receiving multiple ascending doses of ABT-267 or placebo monotherapy for 3 days. |
|
| Resistance Monitoring | No Intervention | HCV genotype 1-infected treatment naïve subjects, receiving at least one dose of ABT-267 or placebo in the "Antiviral Activity" arm, follow-up to monitor resistance developed to ABT-267, no treatment and only blood samples will be collected |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-267 | Drug | See arm description |
|
| Measure | Description | Time Frame |
|---|---|---|
| Analysis of pharmacokinetic variables and mean change in HCV RNA level from baseline. | Up to 15 days or less | |
| Analysis of safety measures including but not limited to tabulation of adverse events, physical exam, vital signs, ECGs, continuous cardiac monitoring, and clinical lab results (including chemistry, hematology and urine). | Update to 20 days or less |
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Inclusion Criteria
Main Selection Criteria for Healthy Volunteers:
Main Selection Criteria for HCV Genotype 1-infected Volunteers:
Main Selection Criteria for Volunteers in the Resistance Monitoring Portion of the Study:
Exclusion Criteria
Main Exclusion Criteria for Healthy Volunteers:
Main Exclusion Criteria for HCV Genotype 1-infected Volunteers:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Campbell, MD | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 42708 | Orlando | Florida | 32809 | United States | ||
| Site Reference ID/Investigator# 43322 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25451055 | Derived | Krishnan P, Beyer J, Mistry N, Koev G, Reisch T, DeGoey D, Kati W, Campbell A, Williams L, Xie W, Setze C, Molla A, Collins C, Pilot-Matias T. In vitro and in vivo antiviral activity and resistance profile of ombitasvir, an inhibitor of hepatitis C virus NS5A. Antimicrob Agents Chemother. 2015 Feb;59(2):979-87. doi: 10.1128/AAC.04226-14. Epub 2014 Dec 1. |
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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 |
|---|---|
| C586094 | ombitasvir |
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| Placebo | Drug | See arms description |
|
| Blood Sample Collection | Procedure | See arm description |
|
| Cytochrome P450 inhibitor | Drug | See arm description |
|
| Waukegan |
| Illinois |
| 60085 |
| United States |
| Site Reference ID/Investigator# 42707 | San Antonio | Texas | 78215 | United States |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |