Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01157104 | A Drug-Drug Interaction Study Evaluating the Combination of IDX320 and IDX184 in Healthy Participants (MK-6844-002) | PHASE1 | COMPLETED | 20 | — | — | Jun 1, 2010 | Aug 1, 2010 | Jan 22, 2016 | - | — |
| Arm | Type | Description |
|---|---|---|
| IDX320 + PBO → IDX320 + IDX184 | EXPERIMENTAL | 400 mg IDX320 and IDX184 matching placebo (PBO) once daily for 7 days; followed by 400 mg IDX320 and 100 mg IDX184 once daily for 7 days |
| IDX184 + PBO → IDX184 + IDX320 | EXPERIMENTAL | 100 mg IDX184 and IDX320 matching PBO for 7 days; followed by 100 mg IDX184 and 400 mg IDX320 for 7 days |
| IDX320 PBO + IDX184 PBO | PLACEBO_COMPARATOR | IDX320 matching PBO + IDX184 matching PBO for 14 days |
| Name | Type | Description |
|---|---|---|
| IDX320 | DRUG | IDX320 400 mg in tablets (8x50 mg) administered orally once daily |
| IDX184 | DRUG | IDX184 100 mg in capsules (2x50 mg) administered orally once daily |
| IDX184 placebo | DRUG | IDX184 matching placebo in capsules administered orally once daily |
| IDX320 placebo | DRUG | IDX320 matching placebo in tablets administered orally once daily |
Inclusion Criteria: To participate in the study, participants must meet the following requirements: 1. Must be a healthy male or female between 19 and 65 years of age with body mass index (BMI) between 18 and 35 kg/m2. 2. Must be a non-smoker. 3. Must agree to use an acceptable double-barrier meth...