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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05387759 | A Thorough QT Study of Aticaprant (JNJ-67953964) in Healthy Adult Participants | PHASE1 | COMPLETED | 60 | — | — | May 30, 2022 | Oct 4, 2022 | Apr 27, 2025 | 1 | Belgium |
Change from baseline in QTc at each time point will be reported.
| Arm | Type | Description |
|---|---|---|
| Treatment Sequence 1 | EXPERIMENTAL | Healthy participants will receive single oral dose of Aticaprant (Dose 1) (Treatment A) in Treatment Period 1, followed by Moxifloxacin (Dose 2) (Treatment D) in Treatment Period 2, followed by Aticaprant (Dose 3) (Treatment B) in Treatment Period 3 and then placebo (Treatment C) in Treatment Period 4, on Day 1 of each treatment period. There will be a wash-out period up to 7-15 days between each treatment period. |
| Treatment Sequence 2 | EXPERIMENTAL | Healthy participants will receive single oral dose of Treatment B in Treatment Period 1, followed by Treatment A in Treatment Period 2, followed by Treatment C in Treatment Period 3 and then Treatment D in Treatment Period 4, on Day 1 of each treatment period. There will be a wash-out period up to 7-15 days between each treatment period. |
| Treatment Sequence 3 | EXPERIMENTAL | Healthy participants will receive single oral dose of Treatment C in Treatment Period 1, followed by Treatment B in Treatment Period 2, followed by Treatment D in Treatment Period 3 and then Treatment A in Treatment Period 4, on Day 1 of each treatment period. There will be a wash-out period up to 7-15 days between each treatment period. |
| Treatment Sequence 4 | EXPERIMENTAL | Healthy participants will receive single oral dose of Treatment D in Treatment Period 1, followed by Treatment C in Treatment Period 2, followed by Treatment A in Treatment Period 3 and then Treatment B in Treatment Period 4, on Day 1 of each treatment period. There will be a wash-out period up to 7 to 15 days between each treatment period. |
| Name | Type | Description |
|---|---|---|
| Aticaprant Supratherapeutic Dose | DRUG | Aticaprant supratherapeutic dose capsule will be administered orally. |
| Aticaprant Therapeutic Dose | DRUG | Aticaprant therapeutic dose capsule will be administered orally. |
| Placebo | DRUG | Placebo will be administered orally. |
| Moxifloxacin | DRUG | Moxifloxacin capsule will be administered orally. |
Inclusion Criteria: * Healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and admission to the study center on Day -1 of the first treatment period. Minor abnormalities in ECG, which are not considered to be of clini...