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The purpose of this study was to determine the safety, tolerability, pharmacokinetics and anti-viral activity of JTK-853 in hepatitis C virus genotype 1 infected subjects based on reduction in viral load (HCV RNA level) from baseline to end of treatment, followed by genotypic resistance monitoring for up to one year after study drug treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose 1 JTK-853 | Experimental |
| |
| Dose 2 JTK-853 | Experimental |
| |
| Dose 3 JTK-853 | Experimental |
| |
| Dose 4 JTK-853 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JTK-853 | Drug | Tablets, twice a day for 3 days |
| |
| Dose 2 JTK-853 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events | 1 week | |
| Maximum concentration (Cmax) of JTK-853 and metabolite M2 | 1 week | |
| Time to reach maximum concentration (tmax) for JTK-853 and metabolite M2 | 1 week | |
| Area under the concentration-time curve during the dosing interval (AUCtau) for JTK-853 and Metabolite M2 | 1 week | |
| Trough concentration during multiple dosing prior to next dose (Ctrough) for JTK-853 and metabolite M2 | 1 week | |
| Viral load change from baseline to end of treatment | 48 weeks | |
| Genotypic resistance assessment and viral load change from baseline over time | 48 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shoji Hoshino, D.V.M | Akros Pharma Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fundacion de Investigacion de Diego | San Juan | 00927 | Puerto Rico |
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| Drug |
Tablets, twice a day for 3 days |
|
| Dose 3 JTK-853 | Drug | Tablets, three times a day for 3 days |
|
| Dose 4 JTK-853 | Drug | Tablets, twice a day for 3 days |
|
| Placebo | Drug | Tablets, twice a day or three times a day for 3 days |
|
| 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 |
|---|---|
| C578010 | JTK-853 |
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