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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-006263-22 | EudraCT Number |
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This study is being done to assess the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of MK-8325 in male hepatitis C virus (HCV)-infected participants. There will be 3 parts to this study. Part I will enroll only genotype 1 (GT1) HCV patients, Part II will enroll only genotype 3 (GT3) HCV-infected participants, and Part III will enroll only GT1a HCV-infected participants. All parts may run concurrently, or may be staggered as needed by the clinical sites.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Panel A (GT1 10 mg) | Experimental |
| |
| Panel B (GT1 50 mg) | Experimental |
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| Panel C (GT1 100 mg) | Experimental |
| |
| Panel D (GT1 200 mg) | Experimental |
| |
| Panel E (GT3 10 mg) | Experimental |
| |
| Panel F (GT3 50 mg) | Experimental |
| |
| Panel G (GT3 100 mg) | Experimental |
| |
| Panel H (GT3 200 mg) | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-8325 | Drug | MK-8325 capsules, orally, once per day for 5 days, at a dose determined by panel assignment (10-200 mg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to Day 5 in plasma HCV ribonucleic acid (RNA) in GT1 participants | Day 1 predose and 2, 4, 8, 12, 24 and 36 hours post-dose, Days 3 and 4 predose, Day 5 predose and 2, 4, 8, 12, and 24 hours post-dose. | |
| Mean maximum reduction from baseline through Day 5 in HCV ribonucleic acid (RNA) in GT3 participants | Day 1 predose and 2, 4, 8, 12, 24 and 36 hours post-dose, Days 3 and 4 predose, Day 5 predose and 2, 4, 8, 12, and 24 hours post-dose. | |
| Number of participants experiencing at least one adverse event | Day 1 up to 56 days | |
| Number of participants discontinuing study drug due to an adverse event | Days 1-5 |
| Measure | Description | Time Frame |
|---|---|---|
| Trough plasma concentration (C24hr) of MK-8325 | Day 1 predose and 0.25 0.5, 1, 2, 4, 5, 6, 7, 8, 12, 16 and 24 hours post-dose and Day 5 predose and 0.25, 0.5, 1, 2, 4, 5, 6, 7, 8, 12, 16, 24, 36,48, 72, 96, 120, 144, 168, 192, 216, and 240 hours post-dose | |
| Area under the concentration curve from Hour 0 to Hour 24 (AUC0-24hr) for MK-8325 |
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Inclusion criteria:
Exclusion criteria:
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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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| ID | Term |
|---|---|
| C000620696 | MK-8325 |
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| Panel I (GT1a 10 mg) | Experimental |
|
| Panel J (GT1a 50 mg) | Experimental |
|
| Placebo Panel | Placebo Comparator |
|
| Placebo | Drug | Placebo to match MK-8325 capsules, orally, once per day for 5 days |
|
| Day 1 predose and 0.25 0.5, 1, 2, 4, 5, 6, 7, 8, 12, 16 and 24 hours post-dose and Day 5 predose and 0.25, 0.5, 1, 2, 4, 5, 6, 7, 8, 12, 16 and 24 hours post-dose |
| Maximum plasma concentration (Cmax) of MK-8325 | Day 1 predose and 0.25 0.5, 1, 2, 4, 5, 6, 7, 8, 12, 16 and 24 hours post-dose and Day 5 predose and 0.25, 0.5, 1, 2, 4, 5, 6, 7, 8, 12, 16, 24, 36,48, 72, 96, 120, 144, 168, 192, 216, and 240 hours post-dose |
| 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 |