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| ID | Type | Description | Link |
|---|---|---|---|
| IDX-06A-004 | Other Identifier | Idenix Protocol Number |
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The purpose of this 3-part study is to evaluate the potential impact of simeprevir and food on pharmacokinetics (PK) of IDX719 in healthy participants. Part 1 will evaluate potential PK interactions between IDX719 and simeprevir. Part 2 will evaluate the effect of food on the PK of IDX719 in combination with simeprevir. Part 3 will evaluate the impact of high- versus low-fat meals on the PK of IDX719.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: IDX719 then IDX719/Simeprevir | Experimental | Healthy participants take IDX719 150 mg once daily (QD) on Days 1-7 and IDX719 150 mg QD + simeprevir 150 mg QD on Days 8-14. |
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| Group B: Simeprevir then IDX719/Simeprevir | Experimental | Healthy participants take simeprevir 150 mg QD on Days 1-7 and IDX719 150 mg QD + simeprevir 150 mg QD on Days 8-14. |
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| Group C: IDX719 | Experimental | Healthy participants take IDX719 150 mg QD on Days 1-14. |
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| Group D: IDX719/Simeprevir | Experimental | Participants from Groups A and B will be asked to return for Group D. Participants take IDX719 and simeprevir QD on Days 1-7 to determine the impact of food on single-dose (on Day 1) and steady state (Day 7) PK. |
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| Group E: High-Fat then Low-Fat PK | Experimental | Participants from Group C will return to determine the PK of IDX719 after high-fat (Day 1) and low-fat (Day 7) meals (Days 2-6 are drug-free washout). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IDX719 | Drug | 50 mg tablet for oral administration |
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| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curve (AUC) at steady-state over dosing interval (AUCss) | Up to 30 days | |
| Maximum observed plasma concentration (Cmax) | Up to 30 days | |
| AUC from time zero to infinity | Up to 30 days | |
| Trough plasma concentration (Ctrough) | Up to 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants experiencing serious adverse events (SAEs) | Up to 30 days | |
| Percentage of participants experiencing adverse events (AEs) | Up to 30 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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| 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 |
|---|---|
| C000597389 | samatasvir |
| D000069616 | Simeprevir |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Group F: Low-Fat then High-Fat PK | Experimental | Participants from Group C will return to determine the PK of IDX719 after low-fat (Day 1) and high-fat (Day 7) meals (Days 2-6 are drug-free washout). |
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| Simeprevir | Drug | 150 mg capsule for oral administration |
|
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| Percentage of participants experiencing Grade 1-4 laboratory abnormalities |
| Up to 30 days |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D006575 |
| Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |