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IDX184 · 4 trials · 4 indications
Monitoring of adverse events, physical examination, routine safety laboratory parameters and electrocardiograms. 1=mild, 2=moderate, 3=severe, 4=potentially life-threatening
| Arm | Type | Description |
|---|---|---|
| IDX184 50 mg + Peg-IFN/RBV | EXPERIMENTAL | IDX184 50 mg and matching placebo once daily plus peginterferon alfa-2a (Peg-IFN) weekly and ribavirin (RBV) daily for 12 weeks followed by Peg-IFN weekly and RBV daily for an additional 12 or 36 weeks. |
| IDX184 100 mg + Peg-IFN/RBV | EXPERIMENTAL | IDX184 100 mg once daily plus Peg-IFN weekly and RBV daily for 12 weeks followed by Peg-IFN weekly and RBV daily for an additional 12 or 36 weeks. |
| IDX184 50 mg QD + Peg-IFN/RBV | EXPERIMENTAL | Participants randomized 4:1 (active:placebo) to receive IDX184 50 mg or placebo once daily (QD) in combination with Peg-IFN/RBV on Days 14-28 and Peg-IFN/RBV on Days 14-28. |
| IDX184 100 mg QD + Peg-IFN/RBV | EXPERIMENTAL | Participants randomized 4:1 (active:placebo) to receive IDX184 50 mg or placebo QD in combination with Peg-IFN/RBV on Days 1-14 and Peg-IFN/RBV alone on Days 14-28. |
| IDX184 100 mg BID + Peg-IFN/RBV | EXPERIMENTAL | Participants randomized 4:1 (active:placebo) to receive IDX184 100 mg or placebo twice daily (BID) in combination with Peg-IFN/RBV on Days 1-14 and Peg-IFN/RBV alone on Days 14-28. |
| IDX184 150 mg QD + Peg-IFN/RBV | EXPERIMENTAL | Participants randomized 4:1 (active:placebo) to receive IDX184 150 mg or placebo QD in combination with Peg-IFN/RBV on Days 1-14 and Peg-IFN/RBV on Days 14-28. |
| IDX184 200 mg QD + Peg-IFN/RBV | EXPERIMENTAL | Participants randomized 4:1 (active:placebo) to receive IDX184 100 mg or placebo QD in combination with Peg-IFN/RBV on Days 1-14 and Peg-IFN/RBV on Days 14-28. |
| IDX184 200 mg BID + Peg-IFN/RBV | EXPERIMENTAL | Participants randomized 4:1 (active:placebo) to receive IDX184 200 mg or placebo BID in combination with Peg-IFN/RBV on Days 1-14 and Peg-IFN/RBV on Days 14-28. |
| Cohort A | EXPERIMENTAL | Subjects randomized 8:2 (active:placebo) to receive one 25 milligrams (mg) capsule of IDX184 per day for 3 days. Fourteen days after treatment, subjects were offered a course of pegylated interferon and ribavirin according to local standard of care. |
| Cohort B | EXPERIMENTAL | Subjects randomized 8:2 (active:placebo) to receive two 25 mg capsules of IDX184 per day for 3 days. Fourteen days after treatment, subjects were offered a course of pegylated interferon and ribavirin according to local standard of care. |
| Cohort C | EXPERIMENTAL | Subjects randomized 8:2 (active:placebo) to receive three 25 mg capsules of IDX184 per day for 3 days. Fourteen days after treatment, subjects were offered a course of pegylated interferon and ribavirin according to local standard of care. |
| Cohort D | EXPERIMENTAL | Subjects randomized 8:2 (active:placebo) to receive four 25 mg capsules of IDX184 per day for 3 days. Fourteen days after treatment, subjects were offered a course of pegylated interferon and ribavirin according to local standard of care. |
| IDX184 5 mg | EXPERIMENTAL | Healthy participants will be administered a single 5 mg dose of IDX184. |
| IDX184 10 mg | EXPERIMENTAL | Healthy participants will be administered a single 10 mg dose of IDX184. |
| IDX184 25 mg | EXPERIMENTAL | Healthy participants will be administered a single 25 mg dose of IDX184. |
| IDX184 50 mg | EXPERIMENTAL | Healthy participants will be administered a single 50 mg dose of IDX184. |
| IDX184 75 mg | EXPERIMENTAL | Healthy participants will be administered a single 75 mg dose of IDX184. |
| IDX184 100 mg | EXPERIMENTAL | Healthy participants will be administered a single 100 mg dose of IDX184. |
| Placebo | PLACEBO_COMPARATOR | Healthy participants will be administered placebo matching IDX184. |
| Name | Type | Description |
|---|---|---|
| IDX184 | DRUG | IDX184 50 mg tablet administered orally |
| Peginterferon alfa-2a (Peg-IFN) | BIOLOGICAL | Peginterferon alfa-2 180 microgram prefilled syringe administered subcutaneously once weekly |
| Ribavirin (RBV) | DRUG | Ribavirin 200 mg tablets administered orally as a divided dose twice daily. Total daily dose to administered will be 1000 or 1200 mg based on body weight. |
| Placebo | DRUG | Matching placebo to IDX184 50 mg tablet administered orally |
Inclusion Criteria: * Males and females with documented genotype 1, chronic hepatitis C infection. * Must agree to use double-barrier method of birth control for at least 6 months after the last dose of study drugs. * Has not received prior antiviral treatment for HCV. * Written informed consent by...
IDX184 is an investigational small molecule being developed for the treatment of chronic hepatitis C infection, including chronic hepatitis C (HCV) and hepatitis C. It has been studied in clinical trials as a monotherapy and in combination with pegylated interferon and ribavirin for patients with chronic hepatitis C.
IDX184 is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The drug is an investigational small molecule in clinical development for the treatment of chronic hepatitis C infection.
IDX184 has completed Phase 1 and Phase 2 clinical trials. It is an investigational drug, meaning it is not approved by the FDA and is still in clinical development. All trials listed for IDX184 have been completed, with no active trials currently ongoing.
IDX184 has been studied in four completed clinical trials: NCT00730431, a single-dose escalation study in healthy volunteers; NCT00807001, a dose-escalation study in treatment-naive chronic hepatitis C subjects; NCT01011166, a safety and antiviral activity study in combination with pegylated interferon and ribavirin; and NCT01371604, a 12-week combination study.
IDX184 is a small molecule designed to treat chronic hepatitis C infection. While the specific molecular target is not disclosed in the available data, it is being studied for its antiviral activity against hepatitis C virus, both alone and in combination with standard therapies.
IDX184 is also referred to as MK-2355 in clinical trial titles. The trials NCT00730431, NCT01011166, and NCT01371604 include MK-2355 in their official titles, indicating that IDX184 and MK-2355 are alternative names for the same investigational drug.