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| ID | Type | Description | Link |
|---|---|---|---|
| IDX-06A-007 | Other Identifier | Idenix Protocol Number |
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| Name | Class |
|---|---|
| Janssen Research & Development, LLC | INDUSTRY |
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The purpose of this study is to evaluate the potential for a PK drug-drug interaction when IDX719, simeprevir, TMC647055 and low-dose ritonavir (RTV) are administered in combination. Safety and tolerability will also be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IDX719 + RTV | Experimental | Participants take IDX719 150 mg once daily (QD) + ritonavir 30 mg QD on Days 1-7, and then take IDX719 150 mg QD + simeprevir 75 mg QD + TMC647055 450 mg QD + RTV 30 mg QD on Days 8-14. |
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| Simeprevir/TMC647055 + RTV | Experimental | Participants take simeprevir 75 mg QD + TMC647055 450 mg QD + RTV 30 mg QD on Days 1-7, and then take IDX719 150 mg QD + simeprevir 75 mg QD + TMC647055 450 mg QD + RTV 30 mg QD on Days 8-14. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IDX719 | Drug | IDX719 will be supplied as a 50 mg tablet for oral administration. |
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| Measure | Description | Time Frame |
|---|---|---|
| Observed maximum plasma drug concentration (Cmax) | Up to 14 days | |
| Time to maximum concentration (Tmax) | Up to 14 days | |
| Area under the drug concentration-plasma time curve from time zero to last measurable concentration (AUC0-t) | Up to 14 days | |
| Predose trough concentration (Ctrough) | Up to 14 days | |
| Apparent terminal elimination rate constant | Up to 14 days | |
| Observed terminal half-life (T1/2) | Up to 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants experiencing serious adverse events (SAEs) | Up to 28 days | |
| Percentage of participants experiencing adverse events (AEs) | Up to 28 days | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| Simeprevir | Drug | Simeprevir will be supplied as 75 mg capsules for oral administration. |
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| TMC647055 | Drug | TMC647055 will be supplied as 150 mg capsules for oral administration. |
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| RTV | Drug | RTV will be supplied as 80 mg/mL solution for oral administration. |
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| Percentage of participants with Grade 1-4 laboratory abnormalities |
| Up to 28 days |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| 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 |
| 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 |
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| ID | Term |
|---|---|
| C000597389 | samatasvir |
| D000069616 | Simeprevir |
| C575713 | 27-cyclohexyl-12,13,16,17-tetrahydro-22-methoxy-11,17-dimethyl-10,10-dioxide-2,19-methano-3,7:4,1-dimetheno-1H,11H-14,10,2,9,11,17-benzoxathiatetraazacyclo docosine-8,18(9H,15H)-dione |
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D013844 | Thiazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
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