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The primary purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and activity of escalating, multiple, oral doses of GS-5885 in subjects with chronic genotype 1 Hepatitis C Virus (HCV) infection. Each participant in the study will be sequestered in the clinic for the initial 5 days of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Active Comparator | GS-5885 (3 mg), once daily or matching placebo, once daily |
|
| Cohort 2 | Active Comparator | GS-5885 (10 mg), once daily or matching placebo, once daily |
|
| Cohort 3 | Active Comparator | GS-5885 (30 mg), once daily or matching placebo, once daily |
|
| Cohort 4 | Active Comparator | GS-5885 ( up to 90 mg), once daily or matching placebo, once daily |
|
| Cohort 5 | Active Comparator | GS-5885 (up to 90 mg), once daily or matching placebo, once daily |
|
| Cohort 6 (optional) | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GS-5885 | Drug | tablet, oral, 3 mg once daily for 3 days |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects reporting an adverse event or experiencing a laboratory abnormality | Safety and tolerability assessments will be performed up to Study Day 14 following administration of multiple doses of GS-5885 or placebo for 3 days | |
| Antiviral activity measures: measured by change in plasma HCV RNA levels form baseline | Assessed up to Study Day 14 following administration of multiple doses of GS-5885 or placebo for 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Measure of GS-5885 plasma concentration over time | Assessed up to Study Day 14 following administration of multiple doses of GS-5885 or placebo for 3 days | |
| Emergence of viral resistance | Up to 48 weeks following Study Day 14 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Diana Brainard, MD | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anaheim | California | 92801 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23877691 | Derived | Wong KA, Worth A, Martin R, Svarovskaia E, Brainard DM, Lawitz E, Miller MD, Mo H. Characterization of Hepatitis C virus resistance from a multiple-dose clinical trial of the novel NS5A inhibitor GS-5885. Antimicrob Agents Chemother. 2013 Dec;57(12):6333-40. doi: 10.1128/AAC.02193-12. Epub 2013 Jul 22. |
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GS-5885 (up to 90 mg), once daily or matching placebo, once daily
|
| Drug |
tablet, oral, once daily for 3 days |
|
| GS-5885 | Drug | tablet, oral, 10 mg once daily for 3 days |
|
| Placebo | Drug | tablet, oral, once daily for 3 days |
|
| GS-5885 | Drug | tablet, oral, 30 mg once daily for 3 days |
|
| Placebo | Drug | tablet, oral, once daily for 3 days |
|
| GS-5885 | Drug | tablet, oral, up to 90 mg once daily for 3 days |
|
| Placebo | Drug | tablet, oral, once daily for 3 days |
|
| GS-5885 | Drug | tablet, oral, up to 90 mg once daily for 3 days |
|
| Placebo | Drug | tablet, oral, once daily for 3 days |
|
| GS-5885 | Drug | tablet, oral, up to 90 mg once daily for 3 days |
|
| Placebo | Drug | tablet, oral, once daily for 3 days |
|
| Cypress |
| California |
| 90630 |
| United States |
| National City | California | 91950 | United States |
| Washington D.C. | District of Columbia | 20010 | United States |
| DeLand | Florida | 32720 | United States |
| Miami | Florida | 33169 | United States |
| Orlando | Florida | 32809 | United States |
| St Louis | Missouri | 63104 | United States |
| Portland | Oregon | 97239 | United States |
| Philadelphia | Pennsylvania | 19139 | United States |
| Houston | Texas | 77030 | United States |
| San Antonio | Texas | 78215 | United States |
| Tacoma | Washington | 98418 | United States |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C586541 | ledipasvir |
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