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IDX719 · 4 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| Cohort 1: Child-Pugh Class A | EXPERIMENTAL | Participants with mild hepatic impairment (Child-Pugh Class A score = 5-6) will receive a single dose of 100 mg IDX719 by mouth on Day 1. |
| Cohort 2: Child-Pugh Class B | EXPERIMENTAL | Participants with moderate hepatic impairment (Child-Pugh Class B score = 7-9) will receive a single dose of 100 mg IDX719 by mouth on Day 1. |
| Cohort 3: Child-Pugh Class C | EXPERIMENTAL | Participants with severe hepatic impairment (Child-Pugh Class C score = 10-15) will receive a single dose of 100 mg IDX719 by mouth on Day 1. |
| 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. |
| 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. |
| 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. |
| 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. |
| Group C: IDX719 | EXPERIMENTAL | Healthy participants take IDX719 150 mg QD on Days 1-14. |
| 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. |
| 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). |
| 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). |
| Group A: Healthy Participants | EXPERIMENTAL | Healthy participants take IDX719 (5 mg - 100 mg) or matching placebo by mouth as either 1 single dose or as 7 daily doses. |
| Group B: HCV Participants | EXPERIMENTAL | Treatment-naive participants infected with HCV genotype (GT) 1, GT2, or GT3 take IDX719 (1 mg - 100 mg) or matching placebo as either 1 single dose or as 7 daily doses. |
| Name | Type | Description |
|---|---|---|
| IDX719 | DRUG | IDX719 supplied as 50 mg tablets. |
| Simeprevir | DRUG | Simeprevir will be supplied as 75 mg capsules for oral administration. |
| TMC647055 | DRUG | TMC647055 will be supplied as 150 mg capsules for oral administration. |
| RTV | DRUG | RTV will be supplied as 80 mg/mL solution for oral administration. |
| Placebo | DRUG | Placebo liquid suspension matching IDX719 taken by mouth. |
Inclusion Criteria: * Read and sign the written informed consent form (ICF) after the nature of the study has been fully explained. * All subjects of childbearing potential must have agreed to use a double method of birth control (one of which must be a barrier) from Screening through at least 90 d...
IDX719 is an investigational small molecule being developed for the treatment of chronic hepatitis C infection. It is a nonstructural protein 5A (NS5A) inhibitor, which means it targets the NS5A protein of the hepatitis C virus to interfere with viral replication. The drug is currently in Phase 1 clinical development.
IDX719 targets the nonstructural protein 5A (NS5A) of the hepatitis C virus. By inhibiting this protein, the drug aims to disrupt the viral replication process. This mechanism is being studied in the context of chronic hepatitis C infection, where the goal is to reduce or eliminate the virus from the body.
IDX719 is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The drug is currently in Phase 1 clinical trials, and Merck is conducting studies to evaluate its safety, tolerability, and pharmacokinetics in healthy volunteers and patients with chronic hepatitis C.
IDX719 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials. All Phase 1 trials for IDX719 have been completed, with no active trials currently ongoing.
IDX719 has been studied in four completed Phase 1 clinical trials. These include NCT01508156, which evaluated the drug in healthy and HCV-infected participants; NCT01813513 and NCT01907724, which assessed drug-drug interactions with other hepatitis C medications; and NCT01919125, which examined pharmacokinetics in participants with normal and impaired hepatic function.
Yes, IDX719 is also known as MK-1894. The clinical trials for this drug are registered under the MK-1894 protocol numbers, such as MK-1894-001, MK-1894-004, MK-1894-007, and MK-1894-008. Both names refer to the same investigational NS5A inhibitor being developed by Merck for chronic hepatitis C.