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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-006296-18 | EudraCT Number |
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This is a multiple dose study of the safety and efficacy of MK-2748 to be done in 2 Parts. Part I will enroll genotype 1 (GT1) hepatitis C virus (HCV)-infected participants and Part II will enroll genotype 3 (GT3) HCV-infected participants. Both Parts may run concurrently or may be staggered.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Panel A: GT1, low dose | Experimental | Participants with genotype 1 (GT1) Hepatitis C Virus (HCV) will receive low dose MK-2748 daily for 7 days. |
|
| Panel B: GT1, lower dose | Experimental | Participants with GT1 HCV will receive lower dose MK-2748 daily for 7 days. |
|
| Panel C: GT1, dose based on Panels A+B | Experimental | Participants with GT1 HCV will be dosed with MK-2748 daily for 7 days based on the safety, pharmacokinetic, and/or pharmacodynamic data from Panels A (low dose) and B (lower dose). |
|
| Panel G: GT1, dose based on Panels A+B+C | Experimental | Participants with GT1 HCV will be dosed with MK-2748 daily for 7 days based on the safety, pharmacokinetic, and/or pharmacodynamic data from Panels A (low dose), B (lower dose), and C. |
|
| Panel H: GT1, dose based on Panels A+B+C+G | Experimental | Participants with GT1 HCV will be dosed with MK-2748 daily for 7 days based on the safety, pharmacokinetic, and/or pharmacodynamic data from Panels A (low dose), B (lower dose), C, and G. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-2748 | Drug | MK-2748 tablets, orally, once daily for 7 days, dose level dependent on Panel assignment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in HCV RNA viral load (log 10 copies/mL) in GT1 HCV-infected participants | Predose on Day 1 through Day 56 | |
| Change from baseline in HCV RNA viral load (log 10 copies/mL) in GT3 HCV-infected participants | Predose on Day 1 through Day 56 | |
| Number of participants experiencing clinical or laboratory adverse events (AEs) | From first dose up to 21 days | |
| Number of participants discontinued from study treatment due to AEs | From Day 1 through Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration curve from Hour 0 to Hour 24 (AUC0-24hr) for MK-2748 | Day 1 and Day 7, predose through 24 hours post-dose | |
| Plasma concentration of MK-2748 (C24) on Day 7 of dosing | 24 hours post-dose on Day 7 |
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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 |
|---|---|
| C000603531 | MK-2748 |
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| Panel D: GT3, low dose (Omitted) | Experimental | Participants with genotype 3 (GT3) HCV were to receive low dose MK-2748 daily for 7 days. Panel D was omitted from the study design and participants were not enrolled in this panel. |
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| Panel E: GT3, high dose | Experimental | Participants with genotype 3 (GT3) HCV will receive high dose MK-2748 daily for 7 days. |
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| Panel F: GT3, dose based on Panel E | Experimental | Participants with GT3 HCV will be dosed with MK-2748 daily for 7 days based on the safety, pharmacokinetic, and/or pharmacodynamic data from Panel E (high dose). |
|
| Panel I: GT3, dose based on Panels E+F | Experimental | Participants with GT3 HCV will be dosed with MK-2748 daily for 7 days based on the safety, pharmacokinetic, and/or pharmacodynamic data from Panels E (high dose) and F. |
|
| Panel J: GT3, dose based on Panels E+F+I | Experimental | Participants with GT3 HCV will be dosed with MK-2748 daily for 7 days based on the safety, pharmacokinetic, and/or pharmacodynamic data from Panels E (high dose), F, and I. |
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| Placebo | Drug | Placebo tablets, orally, once daily for 7 days |
|
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |