Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Loperamide · 1 trial · 1 indication
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...
Loperamide is a small molecule drug being studied for use in drug interaction trials and in healthy participants. It is developed by Johnson & Johnson (JNJ). The drug is currently in Phase 1 clinical development, with studies focused on evaluating its effects and interactions in controlled settings.
Loperamide is developed by Johnson & Johnson, a company traded under the ticker JNJ. The drug is currently in Phase 1 clinical development, with ongoing studies evaluating its effects in healthy participants and drug interaction scenarios.
Loperamide is in Phase 1 clinical development. It has completed two Phase 1 trials, one studying drug interaction and another evaluating its effects on electrocardiogram intervals in healthy participants. The drug is investigational and not yet approved for any indication.
Loperamide has been studied in two completed Phase 1 trials. NCT00806299 examined grapefruit juice interaction, and NCT04225078 evaluated its effects on electrocardiogram intervals in healthy adults. Both trials were completed, with a combined enrollment of 99 participants.
Loperamide is not FDA approved for the indications being studied. It is an investigational drug currently in Phase 1 clinical development, with completed trials focusing on drug interactions and healthy participant safety. Approval status beyond these studies is not established.