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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04225078 | A Study to Evaluate the Effects of Loperamide (JNJ-289679) on Electrocardiogram Intervals in Healthy Adult Participants | PHASE1 | COMPLETED | 66 | — | — | Jan 17, 2020 | Jan 12, 2022 | Mar 30, 2025 | 1 | Belgium |
Change from baseline in QTc intervals for loperamide at therapeutic and supratherapeutic doses will be reported.
The percentage of participants in each treatment having T-wave morphology changes from baseline that represent the appearance or worsening of the morphological abnormality will be reported.
The percentage of participants with the occurrence of abnormal U-waves morphology that represent the appearance or worsening of the morphological abnormality will be reported.
| Arm | Type | Description |
|---|---|---|
| Treatment Sequence 1: Treatment ADBC | EXPERIMENTAL | Participants will receive treatment A (Loperamide therapeutic dose) on Day 1 on treatment period 1, followed by Treatment D (Moxifloxacin) on Day 1 of treatment period 2 followed by Treatment B (Loperamide supratherapeutic dose) on Day 1 of treatment period 3 followed by Treatment C (placebo) on Day 1 of treatment period 4. Each treatment period will be separated by a minimum of 7-day washout period and no more than 21-day. |
| Treatment Sequence 2: Treatment BACD | EXPERIMENTAL | Participants will receive Treatment B on Day 1 of treatment period 1 followed by Treatment A on Day 1 of treatment period 2 then Treatment C on Day 1 of treatment period 3 and then Treatment D on Day 1 of treatment period 4. Each treatment period will be separated by a minimum of 7-day washout period and no more than 21-day. |
| Treatment Sequence 3: Treatment CBDA | EXPERIMENTAL | Participants will receive Treatment C on Day 1 of treatment period 1 followed by Treatment B on Day 1 of treatment period 2 then Treatment D on Day 1 of treatment period 3 and then Treatment A on Day 1 of treatment period 4. Each treatment period will be separated by a minimum of 7-day washout period and no more than 21-day. |
| Treatment Sequence 1: Treatment DCAB | EXPERIMENTAL | Participants will receive Treatment D on Day 1 of treatment period 1 followed by Treatment C on Day 1 of treatment period 2 then Treatment A on Day 1 of treatment period 3 and then Treatment B on Day 1 of treatment period 4. Each treatment period will be separated by a minimum of 7-day washout period and no more than 21-day. |
| Name | Type | Description |
|---|---|---|
| Loperamide | DRUG | Loperamide will be administered as a single oral dose at the expected therapeutic or supratherapeutic doses respectively. |
| Placebo | OTHER | Matching loperamide placebo capsules will be administered orally. |
| Moxifloxacin | DRUG | Moxifloxacin tablets will be administered orally. |
Inclusion Criteria: * All female participants, except if postmenopausal, must have a negative serum beta-human chorionic gonadotropin (beta hCG) pregnancy test at screening and a negative urine pregnancy test on Day 1 of each treatment period * A female participant must agree not to donate eggs (ov...