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 candidate that Johnson & Johnson is developing. It is currently in Phase 1 clinical development, with one completed Phase 1 trial listed. The specific therapeutic indication for this program has not been disclosed, and the compound is identified in chemical databases under the ChEMBL ID CHEMBL219916.
Domperidone targets DRD2, the dopamine D2 receptor, and acts as an antagonist at that receptor. This target class places it among compounds that block dopamine D2 receptor signaling. The drug is a small molecule and is being developed by Johnson & Johnson.
Johnson & Johnson, which trades under the ticker JNJ, is the developer of Domperidone. The company is responsible for the clinical program, which is currently in Phase 1 development. No other development partners are identified for this asset.
Domperidone is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The program has not been approved by the FDA and remains investigational. The completed trial enrolled 44 participants and was conducted in China.
Domperidone has been studied in one completed Phase 1 trial, NCT02816853, titled a study to evaluate the effects of Domperidone on cardiac repolarization in Chinese healthy participants. The trial enrolled 44 healthy volunteers, was randomized, double blind, and controlled, and was conducted in China.