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The purpose of this study it to evaluate the safety and tolerability of VX-985 in HCV subjects. This study will also evaluate the antiviral activity and pharmacokinetic profile of VX-985.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Panel 1: VX-985 Dose 1 | Experimental |
| |
| Panel 2: VX-985 Dose 2 | Experimental |
| |
| Panel 3: VX-985 Dose 3 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VX-985 or matching placebo | Drug | low dose |
| |
| VX-985 or matching placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability (vital signs, 12-lead electrocardiograms, physical examinations, laboratory assessments, and adverse events) | 10-13 days |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma pharmacokinetic parameters of VX-985 | 10-13 days | |
| HCV RNA levels | 5-7 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa Mahnke, MD, PhD | Vertex Pharmaceuticals Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kansas | Overland Park | Kansas | United States | |||
| Maryland |
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| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| Drug |
high dose |
|
| VX-985 or matching placebo | Drug | dose TBD |
|
| Baltimore |
| Maryland |
| United States |
| Washington | Tacoma | Washington | United States |
| 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 |