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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02152332 | A Study to Evaluate the Effects of JNJ-54861911 on Electrocardiogram Intervals in Healthy Particiants | PHASE1 | COMPLETED | 64 | — | — | Jul 1, 2014 | Oct 1, 2014 | Nov 24, 2014 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| Treatment Sequence Group ADBC | EXPERIMENTAL | Participant will receive Treatment A (JNJ-54861911, 50 milligram (mg) once daily for 7 days plus moxifloxacin-matched placebo on Day 7) followed by Treatment D (JNJ-54861911-matched placebo once daily for next 7 days plus moxifloxacin 400 mg on Day 7 of second treatment regimen, then Treatment B (JNJ-54861911, 150 mg once daily for next 7 days plus moxifloxacin-matched placebo on Day 7 of third treatment regimen followed by Treatment C (JNJ-54861911-matched placebo once daily for next 7 days plus moxifloxacin-matched placebo on Day 7 of fourth treatment regimen). |
| Treatment Sequence Group BACD | EXPERIMENTAL | Participant will receive Treatment B (JNJ-54861911, 150 mg once daily for 7 days plus moxifloxacin-matched placebo on Day 7) followed by Treatment A (JNJ-54861911, 50 mg once daily for next 7 days plus moxifloxacin-matched placebo on Day 7 of second treatment regimen), then Treatment C (JNJ-54861911-matched placebo once daily for next 7 days plus moxifloxacin-matched placebo on Day 7 of third treatment regimen) followed by followed by Treatment D (JNJ-54861911-matched placebo once daily for next 7 days plus moxifloxacin 400 mg on Day 7 of fourth treatment regimen). |
| Treatment Sequence Group CBDA | EXPERIMENTAL | Participant will receive Treatment C (JNJ-54861911-matched placebo once daily for next 7 days plus moxifloxacin-matched placebo on Day 7) followed by Treatment B (JNJ-54861911, 150 mg once daily for next 7 days plus moxifloxacin-matched placebo on Day 7 on second treatment regimen), then Treatment D (JNJ-54861911-matched placebo once daily for next 7 days plus moxifloxacin 400 mg on Day 7 of third treatment regimen) followed by Treatment A (JNJ-54861911, 50 mg once daily for next 7 days plus moxifloxacin-matched placebo on Day 7 of fourth treatment regimen). |
| Treatment Sequence Group DCAB | EXPERIMENTAL | Participant will receive Treatment D (JNJ-54861911-matched placebo once daily for 7 days plus moxifloxacin 400 mg on Day 7) followed by Treatment C (JNJ-54861911-matched placebo once daily for next 7 days plus moxifloxacin-matched placebo on Day 7 of second treatment regimen), then Treatment A (JNJ-54861911, 50 mg once daily for next 7 days plus moxifloxacin-matched placebo on Day 7 of third treatment regimen) followed by Treatment B (JNJ-54861911, 150 mg once daily for next 7 days plus moxifloxacin-matched placebo on Day 7 on fourth treatment regimen). |
| Name | Type | Description |
|---|---|---|
| JNJ-54861911-Therapeutic Dose | DRUG | JNJ-54861911 50 mg once daily for 7 days in all treatment sequence. |
| JNJ-54861911 - Supratherapeutic Dose | DRUG | JNJ-54861911 150 mg once daily for 7 days in all treatment sequence. |
| JNJ-54861911-Matched Placebo | DRUG | JNJ-54861911-matched placebo once daily for 7 days in all treatment sequence. |
| Moxifloxacin | DRUG | Moxifloxacin 400 mg on Day 7 in all treatment sequence. |
| Moxifloxacin Matched Placebo | DRUG | Moxifloxacin matched placebo, 400 mg on Day 7 in all treatment sequence. |
Inclusion Criteria: * Signed an informed consent document indicating they understand the purpose of and procedures required for the study, including the required pharmacogenomics component (which specifies testing of genes predisposing to long or short QT and related cardiac syndromes), and are wil...