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This is a Phase 1 Open-Label, Parallel-Group, Single-Dose Study to evaluate the Pharmacokinetics of GS-5816 in subjects with normal hepatic function and moderate or severe hepatic impairment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | (N = 20 Moderately Impaired / Normal Hepatic Function) 100 mg GS-5816. |
|
| Cohort 2 | Experimental | (N = 20 Severely Impaired / Normal Hepatic Function) up to 100 mg GS-5816. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GS-5816 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters of GS-5816 | The primary outcome measure is the pharmacokinetic parameters of GS-5816 which will include AUClast, AUCinf, and Cmax. | Up to one year |
| Measure | Description | Time Frame |
|---|---|---|
| Incidences of adverse events and laboratory abnormalities | The secondary outcome measure is the number of incidences of adverse events and laboratory abnormalities. | Up to one year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Diana Brainard, M.D. | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site | Miami | Florida | 33014 | United States | ||
| Investigational Site |
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| Miami |
| Florida |
| 33169 |
| United States |
| Investigational Site | Orlando | Florida | 32806 | United States |
| Investigational Site | Orlando | Florida | 32809 | United States |
| Investigational Site | San Antonio | Texas | 78215 | United States |
| Investigational Site | San Juan | Puerto Rico | 00927 | Puerto Rico |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| D006526 | Hepatitis C |
| D007239 | Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000604171 | velpatasvir |
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