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This proof of concept study is designed to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of TD-6450 in treatment naïve subjects with GT-1, GT-2 or GT-3 chronic HCV.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TD-6450 | Experimental | TD-6450 capsules |
|
| Placebo | Placebo Comparator | Placebo capsules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TD-6450 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Number, type, severity, and association of treatment emergent adverse events. | 28 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Cmax | 28 Days |
| Tmax | Tmax | 28 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Theravance Biopharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Liver Institute | San Antonio | Texas | 78215 | United States |
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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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|
| AUC0-t |
| 28 Days |
| AUC0-∞ | AUC0-∞ | 28 Days |
| AUC0-24 | 28 Days |
| Antiviral Activity | Change from baseline in HCV RNA | 28 Days |
| t1/2 | t1/2 | 28 Days |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |