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14C-aticaprant · 1 trial · 1 indication
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...
14C-aticaprant is an investigational small molecule being developed by Johnson & Johnson (JNJ). It is a radiolabeled form of aticaprant, used in clinical research to study the drug's absorption, distribution, metabolism, and excretion in the body. It is currently in Phase 1 clinical development.
14C-aticaprant is used in clinical research to study the pharmacokinetics of aticaprant in healthy adult male participants. It is not intended for therapeutic use; rather, it serves as a research tool to understand how the body processes the drug. The study is conducted in healthy volunteers.
14C-aticaprant is developed by Johnson & Johnson, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker JNJ. The company is conducting clinical trials to evaluate the drug's properties in healthy participants.
14C-aticaprant is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and pharmacokinetic profile in humans.
14C-aticaprant has one completed clinical trial, identified as NCT05197062, titled 'A Study of 14C JNJ-67953964 in Healthy Adult Male Participants.' This Phase 1 study enrolled 8 healthy male participants in the Netherlands and was completed. The trial was uncontrolled and not randomized or double-blinded.
14C-aticaprant is a radiolabeled version of aticaprant, where the carbon-14 isotope is incorporated into the molecule. This labeling allows researchers to track the drug's movement and metabolism in the body. It is used specifically for pharmacokinetic studies in healthy volunteers.