Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Domperidone · 1 trial · 1 indication
The QT interval corrected for heart rate (QTc interval) using Fridericia method will be measured by electrocardiograms (ECG).
| Arm | Type | Description |
|---|---|---|
| Sequence 1 | EXPERIMENTAL | Participants will be randomly assigned to 1 of 4 treatment sequence groups based on a computer generated randomization schedule and will receive the following 4 treatments in order specified by randomization: Treatment A (1 domperidone 10 mg tablet 3 times a day (tid) + 1 placebo tablet tid on Days 1 to 3 and a single dose of 1 domperidone 10 mg tablet +1 placebo tablet in the morning of Day 4), Treatment B (2 domperidone 10 mg tablets tid on Days 1 to 3 and a single dose of 2 domperidone 10 mg tablets in the morning of Day 4), Treatment C (2 placebo tablets tid on Days 1 to 3 and a single dose of 2 placebo tablets in the morning of Day 4) and Treatment D (2 placebo tablets tid on Days 1 to 3 and a single dose of 2 placebo tablets + 1 moxifloxacin 400 mg tablet in the morning of Day 4). |
| Sequence 2 | EXPERIMENTAL | Participants will be randomly assigned to 1 of 4 treatment sequence groups based on a computer generated randomization schedule and will receive the following 4 treatments in order specified by randomization: Treatment A (1 domperidone 10 mg tablet 3 times a day (tid) + 1 placebo tablet tid on Days 1 to 3 and a single dose of 1 domperidone 10 mg tablet +1 placebo tablet in the morning of Day 4), Treatment B (2 domperidone 10 mg tablets tid on Days 1 to 3 and a single dose of 2 domperidone 10 mg tablets in the morning of Day 4), Treatment C (2 placebo tablets tid on Days 1 to 3 and a single dose of 2 placebo tablets in the morning of Day 4) and Treatment D (2 placebo tablets tid on Days 1 to 3 and a single dose of 2 placebo tablets + 1 moxifloxacin 400 mg tablet in the morning of Day 4). |
| Sequence 3 | EXPERIMENTAL | Participants will be randomly assigned to 1 of 4 treatment sequence groups based on a computer generated randomization schedule and will receive the following 4 treatments in order specified by randomization: Treatment A (1 domperidone 10 mg tablet 3 times a day (tid) + 1 placebo tablet tid on Days 1 to 3 and a single dose of 1 domperidone 10 mg tablet +1 placebo tablet in the morning of Day 4), Treatment B (2 domperidone 10 mg tablets tid on Days 1 to 3 and a single dose of 2 domperidone 10 mg tablets in the morning of Day 4), Treatment C (2 placebo tablets tid on Days 1 to 3 and a single dose of 2 placebo tablets in the morning of Day 4) and Treatment D (2 placebo tablets tid on Days 1 to 3 and a single dose of 2 placebo tablets + 1 moxifloxacin 400 mg tablet in the morning of Day 4). |
| Sequence 4 | EXPERIMENTAL | Participants will be randomly assigned to 1 of 4 treatment sequence groups based on a computer generated randomization schedule and will receive the following 4 treatments in order specified by randomization: Treatment A (1 domperidone 10 mg tablet 3 times a day (tid) + 1 placebo tablet tid on Days 1 to 3 and a single dose of 1 domperidone 10 mg tablet +1 placebo tablet in the morning of Day 4), Treatment B (2 domperidone 10 mg tablets tid on Days 1 to 3 and a single dose of 2 domperidone 10 mg tablets in the morning of Day 4), Treatment C (2 placebo tablets tid on Days 1 to 3 and a single dose of 2 placebo tablets in the morning of Day 4) and Treatment D (2 placebo tablets tid on Days 1 to 3 and a single dose of 2 placebo tablets + 1 moxifloxacin 400 mg tablet in the morning of Day 4). |
| Name | Type | Description |
|---|---|---|
| Domperidone | DRUG | Domperidone 10 mg or 20 mg tablets will be administered. |
| Placebo | DRUG | Matching placebo will be administered. |
| Moxifloxacin | DRUG | Moxifloxacin 400 mg tablet will be administered. |
Inclusion Criteria: * Participant must be healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at Screening. If there are abnormalities, they must be consistent with the underlying illness in the study population. This determinati...
Domperidone is a small molecule drug being developed by Johnson & Johnson (JNJ). It is currently in Phase 1 clinical development. The drug has been studied in healthy participants, and its therapeutic area is classified as Other.
Domperidone is being investigated for use in healthy participants. It is not approved for any specific indication. The drug is in Phase 1 clinical development, meaning it is still in early-stage testing.
Domperidone is being developed by Johnson & Johnson, which trades under the ticker JNJ. The company is conducting clinical trials to evaluate the drug's effects.
Domperidone is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is still undergoing early-stage clinical testing.
Domperidone has one completed clinical trial, NCT02816853, which studied its effects on cardiac repolarization in Chinese healthy participants. The trial was a randomized, double-blind, controlled study with 44 participants.
Domperidone is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The drug has not completed the clinical trials necessary to seek regulatory approval.