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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-023687-40 | EudraCT Number |
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This is a 2 part study of the safety, pharmacokinetics and pharmacodynamics of MK-6325 in HCV-infected participants. Part I of the study will be for Genotype (GT) 1 HCV-infected participants who will be randomized to receive either MK-6325 or placebo. If the drug is shown to be safe and efficacious in Part I, Part II will enroll GT 3 HCV-infected participants who will be randomized to receive either MK-6325 or placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GT1-HCV 200 mg | Experimental |
| |
| GT1-HCV 400 mg | Experimental |
| |
| GTI-HCV 800 mg | Experimental |
| |
| GT3-HCV 200 mg | Experimental |
| |
| GT3-HCV 400 mg | Experimental |
| |
| GT3-HCV 800 mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-6325 | Drug | Two 100 mg capsules, orally, once per day for 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants experiencing clinical and laboratory adverse events (AEs) (Parts I and II) | Up to 15 days after last dose of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Viral load reduction in GT1 HCV-infected participants (Part I) | 7 Days | |
| Viral load reduction in GT3 HCV-infected participants (Part II) | 7 Days |
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Inclusion criteria:
Exclusion criteria:
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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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| ID | Term |
|---|---|
| C000600429 | MK-6325 |
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| Placebo to MK-6325 | Drug | Two 100 mg capsules, orally, once per day for 7 days |
|
| MK-6325 | Drug | Four 100 mg capsules, orally, once per day for 7 days |
|
| Placebo to MK-6325 | Drug | Four 100 mg capsules, orally, once per day for 7 days |
|
| MK-6325 | Drug | Eight 100 mg capsules, orally, once per day for 7 days |
|
| Placebo to MK-6325 | Drug | Eight 100 mg capsules, orally, once per day for 7 days |
|
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |