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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05197062 | A Study of 14C JNJ-67953964 in Healthy Adult Male Participants | PHASE1 | COMPLETED | 8 | — | — | Jan 14, 2022 | Mar 2, 2022 | Apr 27, 2025 | 1 | Netherlands |
Plasma samples will be analyzed to determine concentrations of aticaprant and its Metabolite M3 using a validated, specific, and sensitive liquid chromatography (LC)-mass spectrometry (MS)/MS method.
Duodenal fluid samples will be analyzed to determine concentrations of aticaprant and its Metabolite M3 using a, specific, and sensitive (LC-MS/MS) method.
Urine samples will be analyzed to determine concentrations of aticaprant and its metabolite M3 using a, specific, and sensitive (LC-MS/MS) method.
Total radioactivity concentration of 14C-aticaprant in whole blood will be performed via liquid scintillation counting.
Total radioactivity concentration of 14C-aticaprant in plasma will be performed via liquid scintillation counting.
Total radioactivity concentration of 14C-aticaprant in duodenal fluid samples will be performed via liquid scintillation counting.
Amount of total radioactivity of 14C-aticaprant in urine will be performed via liquid scintillation counting.
Amount of total radioactivity of 14C-aticaprant in feces will be performed via liquid scintillation counting.
| Arm | Type | Description |
|---|---|---|
| 14C-aticaprant | EXPERIMENTAL | Participants in Group A (without duodenal fluid collection) and Group B (with duodenal fluid collection) will receive a single oral dose of 14C-aticaprant on Day 1. |
| Name | Type | Description |
|---|---|---|
| 14C-aticaprant | DRUG | 14C-aticaprant will be administered orally as capsule on Day 1. |
Inclusion Criteria: * Healthy on the basis of physical examination, medical history (screening only), vital signs, and electrocardiogram (ECG) performed at screening and admission to the study site on Day -1. Minor abnormalities in ECG, which are not considered to be of clinical significance by the...