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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 developed for the treatment of chronic hepatitis C infection. It was studied in adults with chronic HCV, including treatment-naive patients, and was evaluated both as monotherapy and in combination with pegylated interferon and ribavirin. It is not an approved therapy.
IDX184 is being developed by Merck & Company, Inc., which trades under the ticker MRK. Merck's involvement is reflected in the MK-2355 study identifiers attached to the clinical program. The drug originated as a small molecule antiviral candidate for chronic hepatitis C.
IDX184 reached Phase 2 clinical development. Two Phase 2 trials were completed, along with earlier Phase 1 studies, and no trials are currently active. It is an investigational agent and has not been approved by the FDA for any indication.
IDX184 has been studied in completed trials including NCT01371604 and NCT01011166, both Phase 2 studies of the drug combined with pegylated interferon and ribavirin in chronic hepatitis C. Earlier Phase 1 trials include NCT00807001 in treatment-naive HCV patients and NCT00730431 in healthy volunteers.
Across the reported IDX184 studies, total enrollment was 109 participants. The Phase 2 trial NCT01371604 enrolled 68 patients and NCT01011166 enrolled 81 patients, while the Phase 1 studies NCT00807001 and NCT00730431 enrolled 41 and 48 participants respectively. Several trials used randomized, double-blind, controlled designs.
No. IDX184 is an investigational small molecule that remains in clinical development for chronic hepatitis C infection and has not been approved for marketing. Its Phase 2 trials in combination with pegylated interferon and ribavirin have been completed, and no studies of the drug are currently active.